CONTACT: A Non-Randomised Feasibility Study of Bluetooth Enabled Wearables for Contact Tracing in UK Care Homes During the COVID-19 Pandemic.

CONTACT: A Non-Randomised Feasibility Study of Bluetooth Enabled Wearables for Contact Tracing in UK Care Homes During the COVID-19 Pandemic. | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article CONTACT: A Non-Randomised Feasibility Study of Bluetooth Enabled Wearables for Contact Tracing in UK Care Homes During the COVID-19 Pandemic. Carl Thompson, Tom Willis, Amanda Farrin, Adam Gordon, Amrit Dafu-O'Reilly, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3242598/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 02 Oct, 2024 Read the published version in Pilot and Feasibility Studies → Version 1 posted 5 You are reading this latest preprint version Abstract Background: The need for effective non-pharmaceutical infection prevention measures such as contact tracing in pandemics remains in care homes, but traditional approaches to contact tracing are not feasible in care homes. The CONTACT intervention introduces Bluetooth Enabled wearable devices (BLE wearables) as a potential solution for automated contact tracing. Using structured reports and reports triggered by positive COVID-19 cases in homes we fed contact patterns and trends back to homes to support better-informed infection prevention decisions and reduce blanket application of restrictive measures. This paper reports on the evaluation of feasibility and acceptability of the intervention and a planned definitive cluster randomised trial of the CONTACT BLE wearable intervention. Methods: CONTACT was a non-randomised mixed-method feasibility study over two months in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection methods included routine data from the devices, case report forms, qualitative interviews (with staff and residents) and field observation of care and an adapted version of the NoMaD survey instrument to explore implementation using Normalisation Process Theory. Quantitative data were analysed using descriptive statistical methods. Qualitative data was thematically analysed using Normalisation Process Theory. Intervention and study delivery were evaluated against predefined progression criteria. Results: Of 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82.4% (n=178) participated. Device loss and damage were significant: 11% of resident devices were lost or damaged, ~50% were replaced. Staff lost fewer devices, just 6.5%, but less than 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Structured and reactive feedback was variably understood by homes but not likely to be acted on. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. Study participation benefits did not outweigh perceived burden and was amplified by the pandemic context. CONTACT did not meet its quantitative or qualitative progression criteria. Conclusion: CONTACT found a large-scale definitive trial of BLE wearables for contact tracing and feedback-informed IPC in care homes unfeasible and unacceptable - at least in the context of shifting COVID-19 pandemic demands. Future research should co-design interventions and studies with care homes, focusing more on successful intervention implementation than solely on technical effectiveness. ISRCTN registration : 11204126 registered 17/02/2021 Digital contact tracing care homes Bluetooth enabled wearables long term care feasibility COVID-19’ complex interventions. Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Key messages regarding feasibility What uncertainties existed regarding the feasibility? No one has undertaken a randomised clinical trial of Bluetooth enabled (BLE) wearables for contact tracing, a key non-pharmaceutical infection protection and control intervention in long-term care homes. Wearables have shown promise in simulation and modelling studies, but optimal implementation strategies and study procedures for homes participating in a cluster randomised trial are uncertain and untested. What are the key feasibility findings? Despite technical efficacy of the technology, real-world use of BLE wearables in a care home environment and standard procedures associated with cluster randomised trials were not feasible or acceptable to homes - at least not in a pandemic context. What are the implications of the feasibility findings for the design of the main study? The care home context, amplified by pandemic conditions and demands, mean any cluster randomised trial of BLE wearables needs to spend sufficient time on co-designing a theory and evidence-informed implementation strategy for any intervention as well as robust designs for evaluating effectiveness if it is to be acceptable and feasible to homes. Background COVID-19 disproportionately harmed residents and staff of long-term care homes (nursing and residential homes). In England and Wales, almost 17% of the 274,063 deaths in care homes between March 2020 and February 2022 were COVID-19 related, with the virus implicated in 14% of 9,175 deaths of social care staff. 1 Globally, COVID-19 accounted for 429,265 care home resident deaths between February 2020 and April 2022. 2 The highly transmissible, airborne nature of SARS-CoV-2 in confined spaces, and widespread frailty amongst residents, rendered care homes particularly vulnerable. 3 Vaccines have not eradicated COVID-19. Non-pharmaceutical infection prevention and control (IPC) measures such as entry regulation (lockdown and quarantine), contact regulation (contact tracing, physical distancing, isolation), transmission reduction measures (screens, masks, surface cleaning), and surveillance (regular testing), will remain important for homes in future waves of COVID-19 4 and for other respiratory infections prevalent and problematic for care homes – notably, influenza and respiratory syncytial virus (RSV). Homes vary, but IPC measures are often applied on a blanket basis to whole homes, despite needing more high-quality research to validate assumed effectiveness. 4 Contact tracing disrupts infection transmission by identifying and managing individuals exposed to infected people. Its effectiveness hinges on speed, timing, and population tracing comprehensiveness. 5,6 In addition to COVID-19, contact tracing can mitigate infections and deaths from communicable diseases like influenza, norovirus, salmonella, and streptococcus pyogenes, which account for over 50% of care home infections. 7 Traditional contact tracing involves recalling and stating recent contacts, analysing documentary or observational evidence, or using smartphone Bluetooth or GPS capabilities. Unrealistic methods for care homes as dementia and memory problems impact 70–80% of residents, 8 documentation is sometimes of questionable validity as a record of care delivered, 9 smartphone use by residents is far less than the ~ 60% population coverage required for effective tracing 10 and staff may be discouraged from using phones at work. An alternative approach are systems built around Bl uetooth E nabled wearable devices (BLE wearables). BLE wearables harness Bluetooth, low frequency wide area networks/LoRaWAN, and the Internet of Things (IoT) to collect and transmit data on contacts between wearables and IoT devices (who, when, duration, proximity, and location). Wearables can be deployed as fobs, wristwatches, brooches, or cards on lanyards (see Fig. 1 ). BLE wearables have shown promise for analysing proximity networks in healthcare 11 and modelling infections based on hypothetical adoption. 12 Wearables could provide a rapid, automated, and scalable solution for contact tracing in care homes. The CONTACT intervention The CONTACT intervention was a BLE wearable and IoT system for collecting data on contacts and feeding back information contact patterns and trends to care homes. BLE wearables and location markers were deployed to pinpoint contact locations. In collaboration with the PROTECT Covid-19 national core study team, we also installed air quality sensors (in two homes) to monitor CO2 levels, temperature, and humidity. 13 Sensor placement was based on home-supplied floor plans, focusing on areas with high foot traffic, such as communal lounges and dining rooms, and extending to selected bedrooms, staff areas, and key infrastructure (e.g. kitchens). Each system component had a unique QR code identifier allowing us to map each home’s system. Each system took two researchers approximately four hours to install. Consenting staff and residents wore a device while in the home. Each device and location marker’s unique identifier enabled secure de-anonymisation for contact and location tracing purposes by the homes. Contact events (data) from the wearables and location markers were transmitted via a “wave” 14 scanner to a Long-Range Wide Area Network (LoRaWAN) gateway and our commercial partner’s (MicroShare®) network. Anonymised data on devices, location marker IDs, and timestamps were sent to our Clinical Trials Research Unit for analysis: summaries of contacts, trends, and infection risks. These provided the basis of feedback to the homes (see Appendices A and B). Feedback was delivered in a structured monthly report (see appendix A), with ad hoc reports, triggered by notification of COVID-19 positive cases (appendix B) detailing contacts between infected residents and other users. Information was presented back to homes at individual and aggregate levels: who had contact with whom, when, where duration of contact, and mean numbers of contacts, aggregate COVID-19 risk, and where most contacts happened. Reports were based on principles of effective feedback, 15 and co-designed with homes' “study champions”: individuals, usually one sometimes two, appointed by homes to take the lead on CONTACT study tasks, advocated for the study and were a point of contact between home and researchers. Evolutionary changes based on staff feedback included adding key messages from the research team and simplifying the visual representation of infection trends. Reports were emailed to the homes. A researcher followed up three days later to address any questions, with interactions documented for our embedded process evaluation. Rationale BLE wearables make contact tracing in homes feasible by collecting and transmitting significant contact data, filling an information deficit for homes. 16,17 Providing accurate contact information to those in charge of a care home’s IPC could lead to better informed, higher-quality, decisions; potentially reducing infections and avoiding blanket application of often restrictive non-pharmaceutical interventions (“lockdowns”) regardless of individual infections risk levels. Research Aims CONTACT aimed to determine the feasibility and acceptability of a BLE wearable-based contact tracing system among care home residents and staff. We had three main objectives, informing our decision to proceed to a definitive cluster randomised controlled trial of CONTACT versus infection prevention and control as usual in homes: i) assess the acceptability and feasibility of intervention delivery processes, by evaluating a. the contact tracing devices and wider system b. the tailored feedback c. intervention delivery and site engagement ii) assess the acceptability and feasibility of study design/implementation processes, by evaluating a. system software b. main study delivery potential c. data collection iii) decide to progress (or not) to main trial by a. evaluating progress against predefined criteria Methods CONTACT was a non-randomised mixed-methods feasibility study 18 with an embedded parallel process evaluation. It followed a protocol available at https://njl-admin.nihr.ac.uk/document/download/2035361 , with ethical approval from the UK Health Research Authority (REC: 294390). A key change from protocol was an initially planned web-based "dashboard" for real-time, continuously updated reports for each home was dropped due to lack of demand from homes. Participants Eligibility CONTACT was a whole-home intervention. We included all residents, staff, and visitors willing to wear a device, barring exceptions such as residents with disorders like pica that could pose a risk. Eligible homes needed to assign a champion, promote the study, free staff for training, implement the intervention, provide data, and participate in the process evaluation. Identification and consent Homes were recruited using care home research networks (National Institute for Health Research ENRICH 19 ; NICHE-Leeds 20 ). Selection was based on location, staffing, registration type, and resident characteristics (see Table 1 ). Whole-home consent was initially planned, but managers' (in two of the homes) perceptions of wider regulatory requirements meant individual consent processes were used. Individual consent was sought from residents, staff, and nominees/consultees for incapacitated residents. Data collection settings and location Data were collected in four care homes (Table 1 ). Table 1 CONTACT feasibility study care homes Home Type [1] Ownership 21 Maximum capacity Number of staff Number of residents Number of residents with dementia Device type issued Home 1 Residential care For-profit independent 30 25 26 6 Card Home 2 Residential care For-profit independent 15 21 15 2 Card Home 3 Nursing care For-profit independent 28 37 23 5 Fob Home 4 Dual registered for residential and nursing care For-profit Non- Private Equity chain 102 120 87 25 Fob Home One, in urban West Yorkshire, was a for-profit residential home run by an employed manager. It had a staff:resident ratio of 1:1, was a converted large house, with experience of previous research studies. Home Two, a small, owner-managed, for-profit residential care home in rural West Yorkshire, had a staff:resident ratio of 1.4:1. It was purpose-built and had limited research experience. Home Three was an owner-managed for-profit home in affluent North Yorkshire. It was housed in a converted Victorian property, with a staff:resident ratio of 1.6:1. Around 25% of the residents lived with dementia. Home Four was a family-run, non-private equity owned home with both nursing and residential care provisions. It was in a converted factory with large communal areas. It had a staff:resident ratio of 1.4:1. Three floors catered to residents with differing needs (residential, nursing and dementia). All homes were rated good by the Care Quality Commission at point of recruitment and demonstrably committed to the study. Data and analysis Data were verified against a participant list and checked for an appropriate inter-device signal strength. Data not meeting these conditions were excluded. Physical distance between CONTACT wearables was calculated thus: Distance = 10 ^ ((Measured Power-RSSI)/ (10*N)) RSSI (Received Signal Strength Index) was the signal strength as measured by the receiving device. A signal strength of ≤ 75 equated to ≤ 2m. Time was measured in seconds. Contact between devices was in line with government guidance on clinically significant contacts at the time of the study. 22 We assessed home adherence to study procedures and device management qualitatively, examining study fault logs, weekly support call notes, and process evaluation interviews and observations. This approach accompanied our formal feasibility evaluation against progression criteria. Home managers completed an adapted version of the NoMaD questionnaire 23 to assess perceptions of factors relevant to embedding CONTACT as an intervention aimed at changing their work practices. NoMaD has good face validity, construct validity and internal consistency. 23 Quantitative data (including time), was collated, cleaned, and described using summary measures of central tendency, variability, missing values, and bias. OUTCOMES Table 2 outlines the data collection associated with outcomes and study objectives. Table 2 CONTACT feasibility study objectives and outcomes Study Objective Data collection method/outcomes Assess the acceptability and feasibility of intervention delivery processes Contact Tracing Devices Evaluate ease of device administration 5-point Likert scale question(s) measuring ease of use/administration of devices at end of study period. Evaluate feasibility of data collection linking devices with individual identities for residents, staff, and visitors completion levels of resident, staff and visitor wear logs detailing device ID, weekly. Explore acceptability of wearing devices and reasons for non-wear Percentage of participants wearing the device (for the duration of the study) and reasons for non-wear Explore loss/breakage/replacement requirements in a one-month period Number (percentage) of active devices lost/broken/replaced reported in device wear log Tailored feedback Explore feasibility of proposed methods of CONTACT tracing feedback (format, content, frequency) Interviews aimed at understanding and usability of feedback, alongside expressed preferences for content, frequency, and format of the feedback. Evaluate research team processes and capacity for handling queries/problems from homes relating to intervention delivery Logs detailing the number and nature of queries from each site and the time taken to resolve queries. Site engagement – intervention delivery Explore barriers to study champion role in the homes Interviews focused on study role, potential barriers, and levers. Attendance and engagement with face-to-face training for the champion and CONTACT device use understanding Personnel attending vs expected. CRF (Case Report Forms) checklist for the delivery of training elements, details of any changes to training and reasons why, and understanding of key learning objectives. Evaluate feasibility of support phone calls to (intervention) homes Researcher-completed call logs detailing frequency and number (percentage) of successful phone calls completed for each site, call length and reasons for calls not taking place. Attendance and engagement with training webinars Webinar logs completed by training provider, collecting the number of attendees at each webinar. Assess the acceptability and feasibility of study design/implementation processes Device software Evaluate success/failure in data capture, transmission, and analysis as well as rates of contacts and reasons behind the data driven picture. Completion of resident, staff and visitors’ logs cross-checked with flagged data from a random sample (resident/staff) of contact tracing reports to ensure appropriate data capture with documented reasons for missing data (i.e., resident bed-bound/staff leave) Ensure data transmission software works (reading of transferred data at trials unit; storage; analysis) Verification of data retrieved from MicroShare against list of devices known to be sent to home. For each device to be recording data “correctly” it needed to be issued, not showing a continuous contact of > 6 hours and to have at least one additional contact in a day. Thus, for each device we can compare observed (data) vs. expected (data). Investigate non-compliance/site adaptations of technology or study processes Reports generated to identify devices that appear inactive which can be used as an indicator of staff non-compliance at site. Site engagement – study delivery Evaluate site willingness and capacity for definitive main trial; degree of commitment to the study? Interviews to gain feedback on participation and any potential barriers. Site issues managing the study? Logs detailing the nature of queries will be recorded. Additional Feedback from interviews with manager/gatekeeper. Any issues from study team in delivery in the real world? Interviews with key staff on study procedures. Feasibility of collecting (planned definitive study) primary outcome data (COVID-19 test results) Ease of extracting data from care home records; overall number and percentage of residents we know had a COVID-19 test (minimum monthly). The number of positive COVID-19 tests out of those that had a test. [Table 2 here] Prespecified progression criteria We evaluated the acceptability and implementation of the CONTACT intervention after two months at study end (see Table 3 ). Table 3: CONTACT progression criteria Criterion Objective Green Amber Red Acceptability of the intervention Proportion of participants wearing the device 71%+ 51-70% 1 week 20% 21%-30% >31% Acceptability of CONTACT feedback report Demonstrated acceptability of outputs ascertained through home manager interviews. Judged qualitatively with study steering committee Sample size rationale In line with feasibility study guidelines, 24 no formal power calculation was undertaken. With more than 30 residents and staff per home, sufficient participants were in place. For the qualitative study component, we purposively selected staff based on qualifications (including registered nurses and non-registered care staff), their responsibilities (including team leaders and those in managerial roles), and roles (including care and non-care roles like administration and HR). We interviewed residents from both dementia-focused and non-dementia environments - accepting that many residents in both settings lived with dementia, but that residents living in dementia-focussed environments were more likely to show behaviours that might challenge deployment of the technology. Results Recruitment and retention Between November 2021 and March 2022, the four selected care homes (see Table 1 ) ran the CONTACT program 24/7 for two months. Despite ending as planned, the feasibility study did not meet its pre-determined progression criteria for a full RCT (Randomized Control Trial). Of 156 screened residents, 105 consented (either personally or through a nominee) to wear a device, with 102 (97%) wearing them at the start of the two-month intervention. Of the 225 staff deemed eligible, 82.4% (n = 178) agreed to participate, but 20 dropped out before the intervention started. Ineligibility among residents was solely due to staff concerns that wearing the device could pose a risk of harm. Of the residents who declined to wear the devices, 14 did not give a reason, two were disinterested, four did not receive consent from their nominees, and two passed away before they could return their consent forms. Of staff, 17 opted not to participate, with eight outright declining, seven not providing a reason, one objecting to wearing the device, and one simply expressing a lack of enthusiasm. Contextual factors for non-participating staff included six leaving the care home, five with imminent maternity leave, and seven categorized by managers as "rarely present" (sic.) bank staff. The demographic profiles of the homes were female and white. Most residents had been in the homes for an extended period, and both staff and residents had been vaccinated against COVID-19. More than a third of residents lived with a dementia diagnosis (see Table 4 ). Table 4 baseline characteristics of staff and residents Residents (n = 102) Staff (n = 158) Mean Age (SD) 86.1 (8.58) 42.1 (14.75) Male 27 (27.00%) 20 (12.66%) Female 73 (73.00%) 137 (86.71%) Ethnicity: White 101 (100.00%) Length of time in care home in weeks Median (range) 99.5 (2, 590) Previous + COVID-19 test 20 (20.00%) 41 (26.28%) Weeks since + test, Median (range) 47.0 (22, 65) 46.0 (3, 88) COVID-19 Vaccinated 99 (99.00%) 154 (99.35%) dementia diagnosis 38 (37.62%) dementia severity: mild 9 (24.32%) dementia severity: moderate 18 (48.65%) dementia severity: severe 10 (27.03%) Length of employment in home in weeks, median (range) 123.5 (0, 1302) Employment status Permanent 140 (90.32%) Bank 15 (9.68%) Role Direct care/nursing staff 101 (64.33%) Specialist non-clinical role 1 (0.64%) Manager 6 (3.82%) Estates/maintenance 3 (1.91%) Clerical/administrative 7 (4.46%) Catering 17 (10.83%) Cleaner 11 (7.01%) Other (please specify) 11 (7.01%) Work in more than one home: yes 1 (0.63%) Work in more than one home: no 157 (99.37%) Acceptability and feasibility of intervention delivery Ease of administering devices to residents, staff, and external visitors. Getting devices to participants was moderately successful, with 69.5% of screened residents and 86.9% of staff receiving BLE wearables. But, participation in CONTACT was burdensome and added to regular. Staff highlighted screening processes, obtaining consent, and registering participants as particularly laborious. COVID-19 restrictions meant homes conducted recruitment themselves. Their limited digital and data infrastructure meant screening was manual and time-consuming. Larger homes bore a heavier burden. Apart from home four however, all homes managed to complete screening on time. Recruiting residents lacking mental capacity 25 to make decisions for themselves, and thus provide consent, meant contacting designated consultees and further adding to the workload. In some instances, the homes found the workload associated with the study outweighed the perceived benefits. “I find I have to shuffle things around to make it work. When things were heavier, I would usually finish at 5, but during the screening and consent time I had to stay late at night to contact the families. It was hard it fit it into an already hard day” (Home 1, study champion) The study’s research governance requirements contributed to CONTACT’s complexity. Every BLE wearable device's unique number (used by the study team) needed to be cross-referenced against a 'master log' in each home for the home to identify the wearer. Communications involving identifiable data were carried out via a secure file transfer system. However, university secure databases for registering participants and reporting Covid-19 cases encountered technical issues, adding further to delays. Homes 1–3 successfully dispensed devices within a month from consent and before the feasibility start date. Conversely, home four managed to issue only 66% of their BLE wearables after the study start date, with a mean delay of 58.3 days (SD = 26.57). Because of Home 4, the mean time from consent to issuing resident devices was 41 days (SD = 23.87). Several reasons were given for the 10 resident withdrawals, including residents not wanting to wear a device or feeling distressed or confused by them. Issuing staff devices was efficient. Homes distributed them within an average of 36 days (SD = 15.31). Home 4 took slightly longer with an average of 41.5 days (SD = 20.32). Reasons for staff withdrawals included no longer wanting to wear the device and finding the device irritating or inconvenient. An original study objective was assessing the feasibility of BLE wearables for tracking visitors’ (relatives and community professionals) movements within the homes. All the homes conveyed that implementing the necessary procedures for this was not possible due to staffing constraints. Homes one and two did not have permanent reception staff, and the other homes judged the procedures involved too burdensome. Consequently, tracing visitors had to be dropped from study procedures. We successfully appointed study champions in each home. But it was clear that CONTACT related work was in addition to existing work and so deprioritised: It was the time element. I don’t have an administrator or anyone else to help me with my tasks; it’s just me. CONTACT wasn’t at the top of the list by far. We said we would try our best with it, but we couldn’t” (Home 3, manager and champion) Home managers’ NoMaD scored aspects of CONTACT familiarity, and current and future chances of “normalisation” (see Table 5 ). Managers from Homes 1 and 2 had more familiarity with CONTACT at the end of the study, and the manager of Home 1 believed CONTACT could become a regular part of their operations. Feedback from Homes 2 and 4 was less optimistic (see Table 5 ). Table 5 selected adapted NoMaD scores from home managers NoMaD ITEM Home (Start, End) 1 + (S) 2 (S) 2(E) 3 (S) 3 (E) 4 (S) 4 (E) When you use devices how familiar does it feel * 10 8 5 6 10 8 10 CONTACT is currently a normal part of your work * 5 5 5 6 7 8 10 CONTACT will become a normal part of your work * 10 2 - 9 7 10 10 * Rated from 0 (unfamiliar) to 10 (completely familiar) + No completion point data for Home 1 as home manager left before completion. Device loss and damage were noteworthy. 11% of resident devices (n = 12) and 6.5% of staff devices (n = 7) were lost. Almost half (47.4%, n = 9) of lost or damaged devices were replaced. Fewer staff devices were lost (3.2%, n = 5) or damaged (4.4%, n = 7). Just 8.3% (n = 1) were renewed. Fob wearables required frequent battery changes: 15% (n = 38) in Homes 3 and 4. These were supposed to be done by the homes, but Home 4’s delays meant a research team member undertook these over two visits. Card wearables in Homes 1 and 2 required no battery changes. Acceptability and feasibility of structured CONTACT feedback Home ( 1 , 2 and 4 ) managers provided assessments of the i) understandability; ii) influence on IPC thought and iii) likelihood of changes based on the report (Fig. 4 ). Figure 4 suggests certain study aspects were challenging and of limited usefulness. Understanding changes in contacts over time, assessing individual risk presentation, and gathering location information were particularly difficult and the least helpful aspects of the intervention. No home managers were likely to instigate changes based on CONTACT’s structured reports. CONTACT’s research study context, alongside competing pressures such as maintaining staffing and pre-existing infection prevention and control (IPC) requirements, reduced the perceived value of the study's information; contributing to an overall perception that the study was of limited value: “The triggered report covered mostly what we knew already. The scheduled report identified which residents are most at risk, but what can you really do with that information? We can make people isolate but then you lose staff. The staff do a lateral flow test before work every morning, that’s the protection we already have without losing too many staff” (Home 4, study champion) “…it could work, preventing us having to close because we’ve got 2 cases out of 80 for any infection. We can easily isolate pockets of people if we needed to and staff as well. So, I can see if we didn’t have the national guidelines in place, where it would give me research-based information to make risk assessment decisions…. In the guidelines, it does say that registered managers are accountable for decisions. Outside of a trial, it would have given me the confidence to say this is what the infection is doing, and we can safely isolate that and carry on doing what we are doing with the other residents, so the residents don’t suffer from lack of visitors” (Home 4, manager) A significant barrier to feasibility was a staff concern of, “being tracked”. A fear that affected trust and compliance with the study. As a result, scheduled reports were not shared by Home 4’s management with other staff. Reports were disseminated in the other homes. The follow-up support call from researchers after each report was perceived as highly beneficial by managers and champions. Delivering the intervention required training for study champions and home staff. Of the 34 individuals invited to attend virtual training across 9 sessions, almost two-thirds (64.71%) participated. Table 6 CONTACT training session attendance Home invited attended % 1 9 3 33.33% 2 4 4 100.00% 3 7 5 71.43% 4 14 10 71.43% Total 34 22 64.71% Acceptability and feasibility of study design/implementation processes Despite securing the necessary ethical and research governance approvals, we were unable to link residents in the homes to NHS (National Health Service) data. Dialogue with NHS Digital began a year before the intervention period, but linkage proved impossible in the timeframe. DSHC infection and mortality data for the homes was eventually secured - after the intervention period. Data capture Only around 28.7% (n = 70) of the devices functioned as expected, with only minor differences between resident (29.17%) and staff (28.38%) devices. Differences between (Fig. 5 ) and within homes (Fig. 6 ) existed. Apparent device malfunction could be due to battery failure, inappropriate device placement, or staff not updating weekly logs for active devices - a crucial element for correctly processing the dataset. Data transmission from our commercial partner to the university's secure database experienced no issues. During the feasibility period, 33 (32.35%) of 102 residents and 53 (33.54%) of 158 staff reported COVID-19 infections, suggesting self-reported COVID-19 was a feasible primary outcome. However, the single reported case of staff gastroenteritis suggests, "other infections" was a less feasible outcome. Although all homes provided reported deaths (n = 7, 7.14%) during the intervention, only two homes (3 and 4) shared data regarding whether the deaths were COVID-19 related and the months from registration or device issue to death. Despite 86 infection notifications, only 52 (60.46%) contact reports were requested by the homes. Progress against predefined criteria The study did not meet any of our quantitative criteria for progression to a definitive RCT. Additionally, qualitative data from the homes indicated study demands were too burdensome and excessive. Projected compliance and participation rates were too low to justify a definitive trial. Criterion Acceptability of the intervention The number (%) of residents consenting to wearing the device and issued a device at any time during their study period. 62.8% The number (%) of staff consenting to wearing the device and issued a device at any time during their study period. 67.7% Provision of the intervention The proportion of issued resident devices recording “correctly” during the study period. 29.17% Acceptability of scheduled feedback report Demonstrated acceptability of outputs ascertained through manager interviews Discussion A definitive trial of the CONTACT intervention using BLE wearables and feedback to homes for improved IPC decisions, at least in a pandemic context, was unfeasible. The intervention’s development, implementation, and evaluation were executed during the COVID-19 pandemic, a contextual factor that significantly reduced the feasibility of the intervention. The planning and development process was hastily executed, leading to a lack of proper adaptation for a care home context. For instance, BLE fob devices, required cleaning when exposed to human waste or food. More and longer co-produced planning could have allowed for better design adjustments. 26 Implementing CONTACT and study procedures was primarily carried out by the care homes, with minimal in-person support from the research team due to pandemic-related restrictions. They did not have the capacity for this implementation work. We used Normalisation Process Theory (NPT) for planning and implementation to mitigate some of these effects, but its utility was limited in the pressing circumstances of the pandemic. 27 The intervention demanded additional work from care homes already struggling with everyday care. CONTACT’s perceived benefits did not sufficiently outweigh pre-existing methods of IPC, limiting its appeal. 28 The idea of rectifying an information deficit through BLE wearable data and analysis only has merit if information does not come with too high a cost. 29 Like other aspects of health and social care, high quality tailored information does not always lead to informed choices. 30 The “pull” for the information we were “pushing” 31 was further diminished by the - albeit welcome - development of a successful vaccination programme for COVID-19. Technical issues were also a barrier. BLE wearables rely on RSSI signal strength to determine proximity and potential exposure. RSSI can be distorted by physical barriers or other device interference, reducing accuracy. 12,32,33 Further, real-world implementation issues led to suboptimal procedure compliance and low population coverage. As with others’ experiences of tech-enabled contact tracing, privacy was a significant hurdle to implementation. 34 The tracking ability of the technology was seen as intrusive, undermining trust in the technology and IPC amongst staff. CONTACT was designed to offer insight into staff interaction times and movements. This ability to make staff "visible" deterred adoption. Australian care home research suggest limited interactions may make invisibility more desirable than is sometimes assumed. 35,36 Until such privacy concerns can be adequately addressed, the widespread use of wearable technology with tracking and tracing capabilities in care homes remains unlikely. The success of BLE wearables for contact tracing hinges on consistent use and device maintenance by individuals. In care homes, where many residents have cognitive and physical limitations, staff support is crucial. However, staff found the devices intrusive and burdensome. This crucial 28 lack of added value or perceived advantage reduced adoption: unwillingness to encourage residents to participate in the CONTACT study and wear the devices. CONTACT faced a 12-month delay waiting for the permissions from the UK’s Social Care Research Ethics Committee to deliver CONTACT as part of "care as usual" - given the pandemic context. Despite gaining the required permissions, care homes insisted on individual consent procedures, citing fears of punitive action from the Care Quality Commission or litigation risks. These concerns, though unfounded, are indicative of a broader tendency to utilize administrative procedures to mitigate perceived risks - even if such actions might inadvertently compromise care quality. 37 They also reflect a wider failure to support care homes’ research readiness; despite rhetoric from national research funders to the contrary. 38 The movement of people into and between care homes was a significant factor in the spread of COVID-19. 39,40 The burden associated with the CONTACT study, staff restrictions, and infrastructural deficiencies made it impossible to extend the technology to visitors, thereby missing a key source of potential infection tracing. Although we provided CONTACT’s technology to homes free-of-charge, there were associated costs such as data management, analysis, technical support for system installation, battery changes, and replacement devices. Given the perceived lack of value, it seems unlikely that care homes would be willing to absorb these costs or pass them onto the purchasers of care. To effectively utilise the information generated by BLE wearables staff need a degree of information literacy to understand concepts like individualized risk and infection trends. Limited numeracy and information skills can be a barrier to innovation in care homes. 41 Managers suggested CONTACT’s structured reporting used in CONTACT was difficult to comprehend, contributing to the perception that they were unlikely to use the information as a basis for change. This was compounded by a lack of trust in the results among some staff. Implications for future research CONTACT was unfeasible in a pandemic context. Nonetheless, digital contact tracing systems still have some promise; albeit based on low-quality evidence from modelling and simulation studies. 12,42 The implication is that effective implementation is a key determinant of successful contact tracing and improved Infection Prevention and Control (IPC), not the technical efficacy of BLE wearables. 33 Future research involving BLE wearable systems should concentrate on applying known strategies for successful research with care homes 26 and dedicating time to co-produce BLE wearable systems that minimize the burden for participating homes. Facilitators such as privacy, trust, and the utilisation of valuable data from such systems should be a focus of planning and implementation phases. As with any new intervention, implementation failure revealed through evaluation is an essential part of learning and refinement. To maximize this learning, the use of appropriate theories of implementation, innovation adoption, and decision-making can ensure that failures contribute to broader literature and efficient intervention development. In this context, hybrid studies that combine an implementation focus with measuring effectiveness could yield the most valuable insights. 43 Limitations CONTACT had several limitations. Firstly, not all staff and residents who wore the technology took part in feasibility assessment. Positive views of the intervention may have been missed. Additionally, key staff members involved in the study, notably the manager in Home 1, left during the feasibility assessment, destabilising the home and impacting study implementation. Another constraint was the limitation on the research team's presence in the care homes due to COVID-19 restrictions. Our development, implementation, and evaluation processes were largely conducted remotely and virtually; negatively impacting on these critical study aspects. With the easing of restrictions and more time to focus on building relationships during the development, delivery, and evaluation of an intervention, it is conceivable that a CONTACT-style intervention may prove more feasible in the future. CONCLUSION The CONTACT intervention of BLE wearables for contact tracing and feedback was unfeasible and unacceptable to care homes. Intervention planning, execution, and evaluation took place during the COVID-19 pandemic and coincided with the discovery of a successful vaccine against the disease. These factors influenced the research team's methodology and the care homes' willingness and ability to implement the intervention. Despite these setbacks, the technology underpinning CONTACT shows promise. Consequently, future research is recommended, but with an important shift in focus: researchers should aim to co-design studies with care homes and place equal, if not greater, emphasis on the successful implementation of the intervention, rather than the technical effectiveness of the wearable devices. Abbreviations BLE Bluetooth enabled RCT randomised controlled trial RSSI received signal strength indicator NPT Normalisation Process Theory NoMaD Normalisation Measure Development questionnaire NHS National Health Services NIHR National Institute for Health and Social Care Research CONTACT CON tact T r A cing in C are homes using digital T echnology IPC infection prevention and control SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 COVID-19 coronavirus disease IoT Internet of Things GPS global positioning system LoRaWAN Long Range Wide Area Network ENRICH Enabling Research in Care Homes NICHE-Leeds Nurturing Innovation in Care Home Excellence in Leeds CQC Care Quality Commission CRF case report form(s) Declarations Ethics approval and consent to participate CONTACT’s feasibility study and associated process evaluation received approval as part of the CONTACT study by the UK Health Research Authority (REC: 294390). Consent for publication All images have been reproduced with permission from copyright holders. Availability of data and materials The datasets generated and/or analysed during the current study are not publicly available as data contains sensitive information for residents and families of the homes and we cannot rule out the possibility that those close to the homes may think they recognise certain aspects of context. Anonymised Social Network data on contact patterns for four homes are available from the corresponding author on reasonable request. Competing interests During the COVID-19 pandemic CN and AG were participants in the UK Scientific Advisory Group for Emergencies (SAGE), co-chaired the SAGE Environment and Modelling Sub-Group and was a member of the SAGE care home working group. CT has previously provided paid scientific advice to Microshare Ltd and has presented to the SAGE care home working group. Funding Contact Tracing in Care Homes Using Digital Technology (CONTACT) study was commissioned as part of the UK National Institute for Health and Care Research's (NIHR) COVID-19 Recovery and Learning call in April 2020.49 It is funded by the NIHR [HTA programme (NIHR132197)]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Authors' contributions CT was CONTACT’s principal investigator, led the design of the study and writing the paper and takes overall responsibility for content. ADO led on conduct of the process evaluation, data collection and qualitative analysis. AF oversaw quantitative analysis. KK, CN and AK led the technical evaluation of the CONTACT BLE wearable system performance and. CB oversaw economic aspects of CONTACT and helped design various aspects of the study. AG and TH were major contributors to the planning of CONTACT and the clinical dimensions of infection prevention and control. TW oversaw manuscript production and was a major contributor to writing the manuscript. KS was a major contributor to the mixed method analysis, interpretation and discussion of results. All authors helped shape the design of the evaluation and structure and presentation of the findings, read and approved the final manuscript. Acknowledgements We would like to thank Aliah Sagar, Adam Barret; Bonny Cundell; Suzanne Hartly; Amanda Lilly Kelly Ellen Mason and Maree Chaney and other Leeds CTRU staff for their research contributions at various points in the CONTACT study. We would also like to thank the staff and residents of the four care homes involved in the study our study steering committee and PPI members for their valuable oversight and guidance. Finally, our industry partner, Microshare.inc, who provided technology and advice who fairly, flexibly and reasonably adapted their systems to the needs of the homes and research team. References Office for National Statistics. 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Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLOS ONE 11 , e0150205 (2016). ENRICH. https://enrich.nihr.ac.uk/. Niche. https://niche.leeds.ac.uk/. Patwardhan, S., Sutton, M. & Morciano, M. Effects of chain ownership and private equity financing on quality in the English care home sector: retrospective observational study. Age Ageing 51 , afac222 (2022). [Withdrawn] Guidance to assist professionals in advising the general public. GOV.UK https://www.gov.uk/government/publications/novel-coronavirus-2019-ncov-guidance-to-assist-professionals-in-advising-the-general-public/guidance-to-assist-professionals-in-advising-the-general-public (2020). Finch, T. L. et al. Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med. Res. Methodol. 18 , 135 (2018). Lancaster, G. A., Dodd, S. & Williamson, P. R. Design and analysis of pilot studies: recommendations for good practice. J. Eval. Clin. Pract. 10 , 307–312 (2004). Participation, E. Mental Capacity Act 2005. https://www.legislation.gov.uk/ukpga/2005/9/contents. Bunn, F. et al. Setting Priorities to Inform Assessment of Care Homes’ Readiness to Participate in Healthcare Innovation: A Systematic Mapping Review and Consensus Process. Int. J. Environ. Res. Public. Health 17 , 987 (2020). May, C. R. et al. Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. Implement. Sci. 13 , 80 (2018). Rogers, E. M. Diffusion of innovations . (Free Press, 2003). Booth, A. Provocative and Stimulating – but EBLIP (and Information Literacy) are Moving Targets! Evid. Based Libr. Inf. Pract. 5 , 37–42 (2010). Wilson, P. M. et al. Effects of a demand-led evidence briefing service on the uptake and use of research evidence by commissioners of health services: protocol for a controlled before and after study. Implement Sci 10 , 7 (2015). Boaden, R. Push, pull or co-produce? J. Health Serv. Res. Policy 25 , 67–69 (2020). Gendy, M. E. G., Tham, P., Harrison, F. & Yuce, M. R. Comparing Efficiency and Performance of IoT BLE and RFID-Based Systems for Achieving Contract Tracing to Monitor Infection Spread among Hospital and Office Staff. Sensors 23 , 1397 (2023). Khaliq KA, Noakes C, Kemp AH, Thompson C. Evaluating the performance of wearable devices for contact tracing in care home environments. J. Occup. Environ. Hyg. in press , (2023). A cross-country comparison of contact-tracing apps during COVID-19. CEPR https://cepr.org/voxeu/columns/cross-country-comparison-contact-tracing-apps-during-covid-19 (2021). Edwards, H. et al. Resident-staff interactions: a challenge for quality residential aged care. Australas. J. Ageing 22 , 31–37 (2003). Saldert, C., Bartonek-Åhman, H. & Bloch, S. Interaction between Nursing Staff and Residents with Aphasia in Long-Term Care: A Mixed Method Case Study. Nurs. Res. Pract. 2018 , e9418692 (2018). Is excessive paperwork in care homes undermining care for older people? | JRF. https://www.jrf.org.uk/report/excessive-paperwork-care-homes-undermining-care-older-people (2014). Gordon, A. L. et al. The COVID-19 pandemic has highlighted the need to invest in care home research infrastructure. Age Ageing 51 , afac052 (2022). Chen, M. K., Chevalier, J. A. & Long, E. F. Nursing home staff networks and COVID-19. Proc. Natl. Acad. Sci. 118 , e2015455118 (2021). Coronavirus (COVID-19) care home outbreaks - root cause analysis: progress report November 2020 to September 2022. http://www.gov.scot/publications/coronavirus-covid-19-care-home-outbreaks-root-cause-analysis-progress-report-november-2020-september-2022/. Griffiths, A. W. et al. Barriers and facilitators to implementing dementia care mapping in care homes: results from the DCM TM EPIC trial process evaluation. BMC Geriatr. 19 , 37 (2019). Anglemyer, A. et al. Digital contact tracing technologies in epidemics: a rapid review. Cochrane Database Syst Rev 8 , CD013699 (2020). Curran, G. M., Bauer, M., Mittman, B., Pyne, J. M. & Stetler, C. Effectiveness-implementation Hybrid Designs. Med. Care 50 , 217–226 (2012). Footnotes Residential care homes, offer a safe environment for support with personal care, like dressing and washing, activities and opportunities for socialising. Alongside opportunities for socialising, nursing homes provide registered nursing care for those with higher levels of care need (for example, post hospital discharge or with long-term care needs arising from conditions such as dementias). nursing homes have a qualified nurse on site round-the-clock, supported by care assistants, so they can provide a higher level of care. Supplementary Files AppA.pdf AppB.pdf coreqcontact.docx Cite Share Download PDF Status: Published Journal Publication published 02 Oct, 2024 Read the published version in Pilot and Feasibility Studies → Version 1 posted Editorial decision: Major revision 16 Apr, 2024 Reviewers agreed at journal 12 Apr, 2024 Reviewers invited by journal 06 Oct, 2023 Editor assigned by journal 29 Aug, 2023 First submitted to journal 08 Aug, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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19:36:23","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":22186,"visible":true,"origin":"","legend":"","description":"","filename":"coreqcontact.docx","url":"https://assets-eu.researchsquare.com/files/rs-3242598/v1/91906fc31f31a765e7d3b3c6.docx"}],"financialInterests":"","formattedTitle":"CONTACT: A Non-Randomised Feasibility Study of Bluetooth Enabled Wearables for Contact Tracing in UK Care Homes During the COVID-19 Pandemic.","fulltext":[{"header":"Key messages regarding feasibility","content":"\u003cul\u003e\n \u003cli\u003eWhat uncertainties existed regarding the feasibility?\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eNo one has undertaken a randomised clinical trial of Bluetooth enabled (BLE) wearables for contact tracing, a key non-pharmaceutical infection protection and control intervention in long-term care homes. Wearables have shown promise in simulation and modelling studies, but optimal implementation strategies and study procedures for homes participating in a cluster randomised trial are uncertain and untested.\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eWhat are the key feasibility findings?\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eDespite technical efficacy of the technology, real-world use of BLE wearables in a care home environment and standard procedures associated with cluster randomised trials were not feasible or acceptable to homes - at least not in a pandemic context.\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eWhat are the implications of the feasibility findings for the design of the main study?\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe care home context, amplified by pandemic conditions and demands, mean any cluster randomised trial of BLE wearables needs to spend sufficient time on co-designing a theory and evidence-informed implementation strategy for any intervention as well as robust designs for evaluating effectiveness if it is to be acceptable and feasible to homes. \u003c/p\u003e"},{"header":"Background","content":"\u003cp\u003eCOVID-19 disproportionately harmed residents and staff of long-term care homes (nursing and residential homes). In England and Wales, almost 17% of the 274,063 deaths in care homes between March 2020 and February 2022 were COVID-19 related, with the virus implicated in 14% of 9,175 deaths of social care staff.\u003csup\u003e1\u003c/sup\u003e Globally, COVID-19 accounted for 429,265 care home resident deaths between February 2020 and April 2022.\u003csup\u003e2\u003c/sup\u003e The highly transmissible, airborne nature of SARS-CoV-2 in confined spaces, and widespread frailty amongst residents, rendered care homes particularly vulnerable.\u003csup\u003e3\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eVaccines have not eradicated COVID-19. Non-pharmaceutical infection prevention and control (IPC) measures such as entry regulation (lockdown and quarantine), contact regulation (contact tracing, physical distancing, isolation), transmission reduction measures (screens, masks, surface cleaning), and surveillance (regular testing), will remain important for homes in future waves of COVID-19\u003csup\u003e4\u003c/sup\u003e and for other respiratory infections prevalent and problematic for care homes \u0026ndash; notably, influenza and respiratory syncytial virus (RSV). Homes vary, but IPC measures are often applied on a blanket basis to whole homes, despite needing more high-quality research to validate assumed effectiveness.\u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eContact tracing disrupts infection transmission by identifying and managing individuals exposed to infected people. Its effectiveness hinges on speed, timing, and population tracing comprehensiveness.\u003csup\u003e5,6\u003c/sup\u003e In addition to COVID-19, contact tracing can mitigate infections and deaths from communicable diseases like influenza, norovirus, salmonella, and streptococcus pyogenes, which account for over 50% of care home infections.\u003csup\u003e7\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eTraditional contact tracing involves recalling and stating recent contacts, analysing documentary or observational evidence, or using smartphone Bluetooth or GPS capabilities. Unrealistic methods for care homes as dementia and memory problems impact 70\u0026ndash;80% of residents,\u003csup\u003e8\u003c/sup\u003e documentation is sometimes of questionable validity as a record of care delivered,\u003csup\u003e9\u003c/sup\u003e smartphone use by residents is far less than the ~\u0026thinsp;60% population coverage required for effective tracing\u003csup\u003e10\u003c/sup\u003e and staff may be discouraged from using phones at work.\u003c/p\u003e\n\u003cp\u003eAn alternative approach are systems built around \u003cstrong\u003eBl\u003c/strong\u003euetooth \u003cstrong\u003eE\u003c/strong\u003enabled wearable devices (BLE wearables). BLE wearables harness Bluetooth, low frequency wide area networks/LoRaWAN, and the Internet of Things (IoT) to collect and transmit data on contacts between wearables and IoT devices (who, when, duration, proximity, and location). Wearables can be deployed as fobs, wristwatches, brooches, or cards on lanyards (see Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). BLE wearables have shown promise for analysing proximity networks in healthcare\u003csup\u003e11\u003c/sup\u003e and modelling infections based on hypothetical adoption.\u003csup\u003e12\u003c/sup\u003e Wearables could provide a rapid, automated, and scalable solution for contact tracing in care homes.\u003c/p\u003e\n\u003cp\u003eThe CONTACT intervention\u003c/p\u003e\n\u003cp\u003eThe CONTACT intervention was a BLE wearable and IoT system for collecting data on contacts and feeding back information contact patterns and trends to care homes. BLE wearables and location markers were deployed to pinpoint contact locations. In collaboration with the PROTECT Covid-19 national core study team, we also installed air quality sensors (in two homes) to monitor CO2 levels, temperature, and humidity.\u003csup\u003e13\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eSensor placement was based on home-supplied floor plans, focusing on areas with high foot traffic, such as communal lounges and dining rooms, and extending to selected bedrooms, staff areas, and key infrastructure (e.g. kitchens). Each system component had a unique QR code identifier allowing us to map each home\u0026rsquo;s system. Each system took two researchers approximately four hours to install.\u003c/p\u003e\n\u003cp\u003eConsenting staff and residents wore a device while in the home. Each device and location marker\u0026rsquo;s unique identifier enabled secure de-anonymisation for contact and location tracing purposes by the homes.\u003c/p\u003e\n\u003cp\u003eContact events (data) from the wearables and location markers were transmitted via a \u0026ldquo;wave\u0026rdquo;\u003csup\u003e14\u003c/sup\u003e scanner to a Long-Range Wide Area Network (LoRaWAN) gateway and our commercial partner\u0026rsquo;s (MicroShare\u0026reg;) network. Anonymised data on devices, location marker IDs, and timestamps were sent to our Clinical Trials Research Unit for analysis: summaries of contacts, trends, and infection risks. These provided the basis of feedback to the homes (see Appendices A and B).\u003c/p\u003e\n\u003cp\u003eFeedback was delivered in a structured monthly report (see appendix A), with \u003cem\u003ead hoc\u003c/em\u003e reports, triggered by notification of COVID-19 positive cases (appendix B) detailing contacts between infected residents and other users. Information was presented back to homes at individual and aggregate levels: who had contact with whom, when, where duration of contact, and mean numbers of contacts, aggregate COVID-19 risk, and where most contacts happened.\u003c/p\u003e\n\u003cp\u003eReports were based on principles of effective feedback,\u003csup\u003e15\u003c/sup\u003e and co-designed with homes\u0026apos; \u0026ldquo;study champions\u0026rdquo;: individuals, usually one sometimes two, appointed by homes to take the lead on CONTACT study tasks, advocated for the study and were a point of contact between home and researchers. Evolutionary changes based on staff feedback included adding key messages from the research team and simplifying the visual representation of infection trends. Reports were emailed to the homes. A researcher followed up three days later to address any questions, with interactions documented for our embedded process evaluation.\u003c/p\u003e\n\u003cp\u003eRationale\u003c/p\u003e\n\u003cp\u003eBLE wearables make contact tracing in homes feasible by collecting and transmitting significant contact data, filling an information deficit for homes. \u003csup\u003e16,17\u003c/sup\u003e Providing accurate contact information to those in charge of a care home\u0026rsquo;s IPC could lead to better informed, higher-quality, decisions; potentially reducing infections and avoiding blanket application of often restrictive non-pharmaceutical interventions (\u0026ldquo;lockdowns\u0026rdquo;) regardless of individual infections risk levels.\u003c/p\u003e\n\u003cp\u003eResearch Aims\u003c/p\u003e\n\u003cp\u003eCONTACT aimed to determine the feasibility and acceptability of a BLE wearable-based contact tracing system among care home residents and staff.\u003c/p\u003e\n\u003cp\u003eWe had three main objectives, informing our decision to proceed to a definitive cluster randomised controlled trial of CONTACT versus infection prevention and control as usual in homes:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ei) assess the acceptability and feasibility of intervention delivery processes,\u0026nbsp;\u003c/strong\u003eby evaluating\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ea. the \u003cem\u003econtact tracing devices\u003c/em\u003e and \u003cem\u003ewider system\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eb. the \u003cem\u003etailored feedback\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ec. intervention delivery\u003c/em\u003e and \u003cem\u003esite engagement\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eii) assess the acceptability and feasibility of study design/implementation processes,\u0026nbsp;\u003c/strong\u003eby evaluating\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ea. system software\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eb. main study delivery potential\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ec. data collection\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eiii) decide\u0026nbsp;\u003c/strong\u003eto progress (or not) to main trial by\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ea. evaluating progress against predefined criteria\u003c/em\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eCONTACT was a non-randomised mixed-methods feasibility study\u003csup\u003e18\u003c/sup\u003e with an embedded parallel process evaluation. It followed a protocol available at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://njl-admin.nihr.ac.uk/document/download/2035361\u003c/span\u003e\u003cspan address=\"https://njl-admin.nihr.ac.uk/document/download/2035361\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e, with ethical approval from the UK Health Research Authority (REC: 294390). A key change from protocol was an initially planned web-based \"dashboard\" for real-time, continuously updated reports for each home was dropped due to lack of demand from homes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eEligibility\u003c/p\u003e \u003cp\u003eCONTACT was a whole-home intervention. We included all residents, staff, and visitors willing to wear a device, barring exceptions such as residents with disorders like pica that could pose a risk. Eligible homes needed to assign a champion, promote the study, free staff for training, implement the intervention, provide data, and participate in the process evaluation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eIdentification and consent\u003c/h2\u003e \u003cp\u003eHomes were recruited using care home research networks (National Institute for Health Research ENRICH\u003csup\u003e19\u003c/sup\u003e; NICHE-Leeds\u003csup\u003e20\u003c/sup\u003e). Selection was based on location, staffing, registration type, and resident characteristics (see Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Whole-home consent was initially planned, but managers' (in two of the homes) perceptions of wider regulatory requirements meant individual consent processes were used. Individual consent was sought from residents, staff, and nominees/consultees for incapacitated residents.\u003c/p\u003e \u003cp\u003eData collection settings and location\u003c/p\u003e \u003cp\u003eData were collected in four care homes (Table \u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCONTACT feasibility study care homes\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHome\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eType\u003ca class=\"FNLink\" href=\"#Fn1\" id=\"#FNLinkFn1\"\u003e[1]\u003c/a\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eOwnership \u003csup\u003e21\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMaximum capacity\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNumber of staff\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNumber of residents\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eNumber of residents with dementia\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eDevice type issued\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHome 1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResidential care\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFor-profit independent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eCard\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHome 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResidential care\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFor-profit independent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eCard\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHome 3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNursing care\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFor-profit independent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eFob\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHome 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDual registered for residential and nursing care\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFor-profit Non- Private Equity chain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e102\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e120\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eFob\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eHome One, in urban West Yorkshire, was a for-profit residential home run by an employed manager. It had a staff:resident ratio of 1:1, was a converted large house, with experience of previous research studies.\u003c/p\u003e \u003cp\u003eHome Two, a small, owner-managed, for-profit residential care home in rural West Yorkshire, had a staff:resident ratio of 1.4:1. It was purpose-built and had limited research experience.\u003c/p\u003e \u003cp\u003eHome Three was an owner-managed for-profit home in affluent North Yorkshire. It was housed in a converted Victorian property, with a staff:resident ratio of 1.6:1. Around 25% of the residents lived with dementia.\u003c/p\u003e \u003cp\u003eHome Four was a family-run, non-private equity owned home with both nursing and residential care provisions. It was in a converted factory with large communal areas. It had a staff:resident ratio of 1.4:1. Three floors catered to residents with differing needs (residential, nursing and dementia).\u003c/p\u003e \u003cp\u003e All homes were rated good by the Care Quality Commission at point of recruitment and demonstrably committed to the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData and analysis\u003c/h2\u003e \u003cp\u003eData were verified against a participant list and checked for an appropriate inter-device signal strength. Data not meeting these conditions were excluded.\u003c/p\u003e \u003cp\u003ePhysical distance between CONTACT wearables was calculated thus:\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eDistance\u0026thinsp;=\u0026thinsp;10 ^ ((Measured Power-RSSI)/ (10*N))\u003c/h2\u003e \u003cp\u003eRSSI (Received Signal Strength Index) was the signal strength as measured by the receiving device. A signal strength of \u0026le;\u0026thinsp;75 equated to \u0026le;\u0026thinsp;2m. Time was measured in seconds. Contact between devices was in line with government guidance on clinically significant contacts at the time of the study.\u003csup\u003e22\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eWe assessed home adherence to study procedures and device management qualitatively, examining study fault logs, weekly support call notes, and process evaluation interviews and observations. This approach accompanied our formal feasibility evaluation against progression criteria.\u003c/p\u003e \u003cp\u003eHome managers completed an adapted version of the NoMaD questionnaire\u003csup\u003e23\u003c/sup\u003e to assess perceptions of factors relevant to embedding CONTACT as an intervention aimed at changing their work practices. NoMaD has good face validity, construct validity and internal consistency.\u003csup\u003e23\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eQuantitative data (including time), was collated, cleaned, and described using summary measures of central tendency, variability, missing values, and bias.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eOUTCOMES\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e outlines the data collection associated with outcomes and study objectives.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCONTACT feasibility study objectives and outcomes\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy Objective\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eData collection method/outcomes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eAssess the acceptability and feasibility of intervention delivery processes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cem\u003eContact Tracing Devices\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvaluate ease of device administration\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5-point Likert scale question(s) measuring ease of use/administration of devices at end of study period.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvaluate feasibility of data collection linking devices with individual identities for residents, staff, and visitors\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ecompletion levels of resident, staff and visitor wear logs detailing device ID, weekly.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExplore acceptability of wearing devices and reasons for non-wear\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePercentage of participants wearing the device (for the duration of the study) and reasons for non-wear\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExplore loss/breakage/replacement requirements in a one-month period\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNumber (percentage) of active devices lost/broken/replaced reported in device wear log\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTailored feedback\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExplore feasibility of proposed methods of CONTACT tracing feedback (format, content, frequency)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInterviews aimed at understanding and usability of feedback, alongside expressed preferences for content, frequency, and format of the feedback.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvaluate research team processes and capacity for handling queries/problems from homes relating to intervention delivery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLogs detailing the number and nature of queries from each site and the time taken to resolve queries.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSite engagement \u0026ndash; intervention delivery\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExplore barriers to study champion role in the homes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInterviews focused on study role, potential barriers, and levers.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAttendance and engagement with face-to-face training for the champion and CONTACT device use understanding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePersonnel attending vs expected. CRF (Case Report Forms) checklist for the delivery of training elements, details of any changes to training and reasons why, and understanding of key learning objectives.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvaluate feasibility of support phone calls to (intervention) homes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResearcher-completed call logs detailing frequency and number (percentage) of successful phone calls completed for each site, call length and reasons for calls not taking place.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAttendance and engagement with training webinars\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWebinar logs completed by training provider, collecting the number of attendees at each webinar.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAssess the acceptability and feasibility of study design/implementation processes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDevice software\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvaluate success/failure in data capture, transmission, and analysis as well as rates of contacts and reasons behind the data driven picture.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCompletion of resident, staff and visitors\u0026rsquo; logs cross-checked with flagged data from a random sample (resident/staff) of contact tracing reports to ensure appropriate data capture with documented reasons for missing data (i.e., resident bed-bound/staff leave)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnsure data transmission software works (reading of transferred data at trials unit; storage; analysis)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVerification of data retrieved from MicroShare against list of devices known to be sent to home. For each device to be recording data \u0026ldquo;correctly\u0026rdquo; it needed to be issued, not showing a continuous contact of \u0026gt;\u0026thinsp;6 hours and to have at least one additional contact in a day. Thus, for each device we can compare observed (data) vs. expected (data).\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInvestigate non-compliance/site adaptations of technology or study processes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eReports generated to identify devices that appear inactive which can be used as an indicator of staff non-compliance at site.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSite engagement \u0026ndash; study delivery\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEvaluate site willingness and capacity for definitive main trial; degree of commitment to the study?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInterviews to gain feedback on participation and any potential barriers.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSite issues managing the study?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLogs detailing the nature of queries will be recorded. Additional Feedback from interviews with manager/gatekeeper.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAny issues from study team in delivery in the real world?\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInterviews with key staff on study procedures.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFeasibility of collecting (planned definitive study) primary outcome data (COVID-19 test results)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEase of extracting data from care home records; overall number and percentage of residents we know had a COVID-19 test (minimum monthly). The number of positive COVID-19 tests out of those that had a test.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e[Table \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e here]\u003c/h2\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003ePrespecified progression criteria\u003c/h2\u003e \u003cp\u003eWe evaluated the acceptability and implementation of the CONTACT intervention after two months at study end (see Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \n\u003cp\u003eTable 3: CONTACT progression criteria\u003c/pp\u003e\n\u003ctable style=\"width:503.0pt;border-collapse:collapse;border:none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 83.5pt;border: 1pt solid windowtext;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border:none;text-align:center;line-height:115%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Segoe UI\",sans-serif;'\u003eCriterion\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 206.85pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border:none;text-align:center;line-height:115%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Segoe UI\",sans-serif;'\u003eObjective\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.85pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;background: rgb(146, 208, 80);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border:none;text-align:center;line-height:115%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Segoe UI\",sans-serif;'\u003eGreen\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.9pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;background: rgb(255, 192, 0);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border:none;text-align:center;line-height:115%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Segoe UI\",sans-serif;'\u003eAmber\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.9pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;background: red;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border:none;text-align:center;line-height:115%;'\u003e\u003cstrong\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Segoe UI\",sans-serif;'\u003eRed\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 83.5pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eAcceptability of the intervention\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 206.85pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eProportion of participants wearing the device\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.85pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: rgb(146, 208, 80);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:black;\"\u003e71%+\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.9pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: rgb(255, 192, 0);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:black;\"\u003e51-70%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.9pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: red;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:black;\"\u003e\u0026lt;50%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 83.5pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eProvision of the intervention\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 206.85pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eProportion of active CONTACT devices not recording data for \u0026gt;1 week\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.85pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: rgb(146, 208, 80);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:black;\"\u003e20%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.9pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: rgb(255, 192, 0);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:black;\"\u003e21%-30%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70.9pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: red;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:black;\"\u003e\u0026gt;31%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 83.5pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eAcceptability of CONTACT feedback report\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 206.85pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eDemonstrated acceptability of outputs ascertained through home manager interviews.\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" style=\"width: 212.65pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: black;padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:white;\"\u003eJudged qualitatively with study steering committee\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\u003c/br\u003e\n \u003cp\u003eSample size rationale\u003c/p\u003e \u003cp\u003eIn line with feasibility study guidelines,\u003csup\u003e24\u003c/sup\u003e no formal power calculation was undertaken. With more than 30 residents and staff per home, sufficient participants were in place. For the qualitative study component, we purposively selected staff based on qualifications (including registered nurses and non-registered care staff), their responsibilities (including team leaders and those in managerial roles), and roles (including care and non-care roles like administration and HR). We interviewed residents from both dementia-focused and non-dementia environments - accepting that many residents in both settings lived with dementia, but that residents living in dementia-focussed environments were more likely to show behaviours that might challenge deployment of the technology.\u003c/p\u003e "},{"header":"Results","content":"\u003cp\u003eRecruitment and retention\u003c/p\u003e \u003cp\u003eBetween November 2021 and March 2022, the four selected care homes (see Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) ran the CONTACT program 24/7 for two months. Despite ending as planned, the feasibility study did not meet its pre-determined progression criteria for a full RCT (Randomized Control Trial).\u003c/p\u003e \u003cp\u003eOf 156 screened residents, 105 consented (either personally or through a nominee) to wear a device, with 102 (97%) wearing them at the start of the two-month intervention. Of the 225 staff deemed eligible, 82.4% (n\u0026thinsp;=\u0026thinsp;178) agreed to participate, but 20 dropped out before the intervention started.\u003c/p\u003e \u003cp\u003eIneligibility among residents was solely due to staff concerns that wearing the device could pose a risk of harm. Of the residents who declined to wear the devices, 14 did not give a reason, two were disinterested, four did not receive consent from their nominees, and two passed away before they could return their consent forms.\u003c/p\u003e \u003cp\u003eOf staff, 17 opted not to participate, with eight outright declining, seven not providing a reason, one objecting to wearing the device, and one simply expressing a lack of enthusiasm. Contextual factors for non-participating staff included six leaving the care home, five with imminent maternity leave, and seven categorized by managers as \"rarely present\" (sic.) bank staff.\u003c/p\u003e \u003cp\u003eThe demographic profiles of the homes were female and white. Most residents had been in the homes for an extended period, and both staff and residents had been vaccinated against COVID-19. More than a third of residents lived with a dementia diagnosis (see Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ebaseline characteristics of staff and residents\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResidents\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;102)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStaff\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;158)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean Age (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e86.1 (8.58)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e42.1 (14.75)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27 (27.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20 (12.66%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e73 (73.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e137 (86.71%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEthnicity: White\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e101 (100.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLength of time in care home in weeks\u003c/p\u003e \u003cp\u003eMedian (range)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e99.5 (2, 590)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrevious\u0026thinsp;+\u0026thinsp;COVID-19 test\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (20.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e41 (26.28%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeeks since +\u0026thinsp;test, Median (range)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e47.0 (22, 65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e46.0 (3, 88)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCOVID-19 Vaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e99 (99.00%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e154 (99.35%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003edementia diagnosis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38 (37.62%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003edementia severity: mild\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (24.32%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003edementia severity: moderate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18 (48.65%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003edementia severity: severe\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10 (27.03%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLength of employment in home in weeks, median (range)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e123.5 (0, 1302)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eEmployment status\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePermanent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e140 (90.32%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBank\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15 (9.68%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eRole\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDirect care/nursing staff\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e101 (64.33%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpecialist non-clinical role\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (0.64%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eManager\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (3.82%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEstates/maintenance\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (1.91%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClerical/administrative\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (4.46%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCatering\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17 (10.83%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCleaner\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (7.01%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther (please specify)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (7.01%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWork in more than one home: yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (0.63%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWork in more than one home: no\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e157 (99.37%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAcceptability and feasibility of intervention delivery\u003c/p\u003e \u003cp\u003eEase of administering devices to residents, staff, and external visitors.\u003c/p\u003e \u003cp\u003eGetting devices to participants was moderately successful, with 69.5% of screened residents and 86.9% of staff receiving BLE wearables. But, participation in CONTACT was burdensome and added to regular. Staff highlighted screening processes, obtaining consent, and registering participants as particularly laborious. COVID-19 restrictions meant homes conducted recruitment themselves. Their limited digital and data infrastructure meant screening was manual and time-consuming. Larger homes bore a heavier burden. Apart from home four however, all homes managed to complete screening on time.\u003c/p\u003e \u003cp\u003eRecruiting residents lacking mental capacity\u003csup\u003e25\u003c/sup\u003e to make decisions for themselves, and thus provide consent, meant contacting designated consultees and further adding to the workload. In some instances, the homes found the workload associated with the study outweighed the perceived benefits.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I find I have to shuffle things around to make it work. When things were heavier, I would usually finish at 5, but during the screening and consent time I had to stay late at night to contact the families. It was hard it fit it into an already hard day\u0026rdquo;\u003c/em\u003e (Home 1, study champion)\u003c/p\u003e \u003cp\u003eThe study\u0026rsquo;s research governance requirements contributed to CONTACT\u0026rsquo;s complexity. Every BLE wearable device's unique number (used by the study team) needed to be cross-referenced against a 'master log' in each home for the home to identify the wearer. Communications involving identifiable data were carried out via a secure file transfer system. However, university secure databases for registering participants and reporting Covid-19 cases encountered technical issues, adding further to delays.\u003c/p\u003e \u003cp\u003eHomes 1\u0026ndash;3 successfully dispensed devices within a month from consent and before the feasibility start date. Conversely, home four managed to issue only 66% of their BLE wearables after the study start date, with a mean delay of 58.3 days (SD\u0026thinsp;=\u0026thinsp;26.57). Because of Home 4, the mean time from consent to issuing resident devices was 41 days (SD\u0026thinsp;=\u0026thinsp;23.87). Several reasons were given for the 10 resident withdrawals, including residents not wanting to wear a device or feeling distressed or confused by them.\u003c/p\u003e \u003cp\u003eIssuing staff devices was efficient. Homes distributed them within an average of 36 days (SD\u0026thinsp;=\u0026thinsp;15.31). Home 4 took slightly longer with an average of 41.5 days (SD\u0026thinsp;=\u0026thinsp;20.32). Reasons for staff withdrawals included no longer wanting to wear the device and finding the device irritating or inconvenient.\u003c/p\u003e \u003cp\u003eAn original study objective was assessing the feasibility of BLE wearables for tracking visitors\u0026rsquo; (relatives and community professionals) movements within the homes. All the homes conveyed that implementing the necessary procedures for this was not possible due to staffing constraints. Homes one and two did not have permanent reception staff, and the other homes judged the procedures involved too burdensome. Consequently, tracing visitors had to be dropped from study procedures.\u003c/p\u003e \u003cp\u003eWe successfully appointed study champions in each home. But it was clear that CONTACT related work was in addition to existing work and so deprioritised:\u003c/p\u003e \u003cp\u003e \u003cem\u003eIt was the time element. I don\u0026rsquo;t have an administrator or anyone else to help me with my tasks; it\u0026rsquo;s just me. CONTACT wasn\u0026rsquo;t at the top of the list by far. We said we would try our best with it, but we couldn\u0026rsquo;t\u0026rdquo;\u003c/em\u003e (Home 3, manager and champion)\u003c/p\u003e \u003cp\u003eHome managers\u0026rsquo; NoMaD scored aspects of CONTACT familiarity, and current and future chances of \u0026ldquo;normalisation\u0026rdquo; (see Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). Managers from Homes 1 and 2 had more familiarity with CONTACT at the end of the study, and the manager of Home 1 believed CONTACT could become a regular part of their operations. Feedback from Homes 2 and 4 was less optimistic (see Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eselected adapted NoMaD scores from home managers\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNoMaD ITEM\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"7\" nameend=\"c8\" namest=\"c2\"\u003e \u003cp\u003eHome (Start, End)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003csup\u003e+\u003c/sup\u003e (S)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (S)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2(E)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (S)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3 (E)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4 (S)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e4 (E)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWhen you use devices how familiar does it feel\u003c/b\u003e\u003csup\u003e\u003cb\u003e*\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCONTACT is currently a normal part of your work\u003c/b\u003e\u003csup\u003e\u003cb\u003e*\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCONTACT will become a normal part of your work\u003c/b\u003e\u003csup\u003e\u003cb\u003e*\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003e\u003csup\u003e\u003cem\u003e*\u003c/em\u003e\u003c/sup\u003e\u003cem\u003eRated from 0 (unfamiliar) to 10 (completely familiar)\u003c/em\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003csup\u003e \u003cem\u003e+\u003c/em\u003e \u003c/sup\u003e \u003cem\u003eNo completion point data for Home 1 as home manager left before completion.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eDevice loss and damage were noteworthy. 11% of resident devices (n\u0026thinsp;=\u0026thinsp;12) and 6.5% of staff devices (n\u0026thinsp;=\u0026thinsp;7) were lost. Almost half (47.4%, n\u0026thinsp;=\u0026thinsp;9) of lost or damaged devices were replaced. Fewer staff devices were lost (3.2%, n\u0026thinsp;=\u0026thinsp;5) or damaged (4.4%, n\u0026thinsp;=\u0026thinsp;7). Just 8.3% (n\u0026thinsp;=\u0026thinsp;1) were renewed.\u003c/p\u003e \u003cp\u003eFob wearables required frequent battery changes: 15% (n\u0026thinsp;=\u0026thinsp;38) in Homes 3 and 4. These were supposed to be done by the homes, but Home 4\u0026rsquo;s delays meant a research team member undertook these over two visits. Card wearables in Homes 1 and 2 required no battery changes.\u003c/p\u003e \u003cp\u003eAcceptability and feasibility of structured CONTACT feedback\u003c/p\u003e \u003cp\u003eHome (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e and \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) managers provided assessments of the i) understandability; ii) influence on IPC thought and iii) likelihood of changes based on the report (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e4\u003c/span\u003e suggests certain study aspects were challenging and of limited usefulness. Understanding changes in contacts over time, assessing individual risk presentation, and gathering location information were particularly difficult and the least helpful aspects of the intervention.\u003c/p\u003e \u003cp\u003eNo home managers were likely to instigate changes based on CONTACT\u0026rsquo;s structured reports. CONTACT\u0026rsquo;s research study context, alongside competing pressures such as maintaining staffing and pre-existing infection prevention and control (IPC) requirements, reduced the perceived value of the study's information; contributing to an overall perception that the study was of limited value:\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;The triggered report covered mostly what we knew already. The scheduled report identified which residents are most at risk, but what can you really do with that information? We can make people isolate but then you lose staff. The staff do a lateral flow test before work every morning, that\u0026rsquo;s the protection we already have without losing too many staff\u0026rdquo;\u003c/em\u003e (Home 4, study champion)\u003c/p\u003e \u003cp\u003e\u003cem\u003e\u0026ldquo;\u0026hellip;it could work, preventing us having to close because we\u0026rsquo;ve got 2 cases out of 80 for any infection. We can easily isolate pockets of people if we needed to and staff as well. So, I can see if we didn\u0026rsquo;t have the national guidelines in place, where it would give me research-based information to make risk assessment decisions\u0026hellip;. In the guidelines, it does say that registered managers are accountable for decisions. Outside of a trial, it would have given me the confidence to say this is what the infection is doing, and we can safely isolate that and carry on doing what we are doing with the other residents, so the residents don\u0026rsquo;t suffer from lack of visitors\u0026rdquo;\u003c/em\u003e (Home 4, manager)\u003c/p\u003e \u003cp\u003eA significant barrier to feasibility was a staff concern of, \u0026ldquo;being tracked\u0026rdquo;. A fear that affected trust and compliance with the study. As a result, scheduled reports were not shared by Home 4\u0026rsquo;s management with other staff. Reports were disseminated in the other homes. The follow-up support call from researchers after each report was perceived as highly beneficial by managers and champions.\u003c/p\u003e \u003cp\u003eDelivering the intervention required training for study champions and home staff. Of the 34 individuals invited to attend virtual training across 9 sessions, almost two-thirds (64.71%) participated.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 6\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCONTACT training session attendance\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHome\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003einvited\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eattended\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e33.33%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100.00%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e71.43%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e71.43%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e34\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e22\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e64.71%\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAcceptability and feasibility of study design/implementation processes\u003c/p\u003e \u003cp\u003eDespite securing the necessary ethical and research governance approvals, we were unable to link residents in the homes to NHS (National Health Service) data. Dialogue with NHS Digital began a year before the intervention period, but linkage proved impossible in the timeframe. DSHC infection and mortality data for the homes was eventually secured - \u003cem\u003eafter\u003c/em\u003e the intervention period.\u003c/p\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eData capture\u003c/h2\u003e \u003cp\u003eOnly around 28.7% (n\u0026thinsp;=\u0026thinsp;70) of the devices functioned as expected, with only minor differences between resident (29.17%) and staff (28.38%) devices. Differences between (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e5\u003c/span\u003e) and within homes (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e6\u003c/span\u003e) existed. Apparent device malfunction could be due to battery failure, inappropriate device placement, or staff not updating weekly logs for active devices - a crucial element for correctly processing the dataset. Data transmission from our commercial partner to the university's secure database experienced no issues.\u003c/p\u003e \u003cp\u003eDuring the feasibility period, 33 (32.35%) of 102 residents and 53 (33.54%) of 158 staff reported COVID-19 infections, suggesting self-reported COVID-19 was a feasible primary outcome. However, the single reported case of staff gastroenteritis suggests, \"other infections\" was a less feasible outcome. Although all homes provided reported deaths (n\u0026thinsp;=\u0026thinsp;7, 7.14%) during the intervention, only two homes (3 and 4) shared data regarding whether the deaths were COVID-19 related and the months from registration or device issue to death. Despite 86 infection notifications, only 52 (60.46%) contact reports were requested by the homes.\u003c/p\u003e \u003cp\u003eProgress against predefined criteria\u003c/p\u003e \u003cp\u003eThe study did not meet any of our quantitative criteria for progression to a definitive RCT. Additionally, qualitative data from the homes indicated study demands were too burdensome and excessive. Projected compliance and participation rates were too low to justify a definitive trial.\u003c/p\u003e \n\u003ctable style=\"width:483.3pt;border-collapse:collapse;border:none;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 99pt;border: 1pt solid windowtext;padding: 0in 5.4pt;height: 11.45pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cstrong\u003e\u003cspan style=\"font-size:13px;\"\u003eCriterion\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 205.55pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;padding: 0in 5.4pt;height: 11.45pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cstrong\u003e\u003cspan style=\"font-size:13px;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 178.75pt;border-top: 1pt solid windowtext;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-image: initial;border-left: none;padding: 0in 5.4pt;height: 11.45pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 99pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 40.8pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eAcceptability of the intervention\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 205.55pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 40.8pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eThe number (%) of\u003cstrong\u003e\u0026nbsp;residents\u003c/strong\u003e consenting to wearing the device and issued a device at any time during their study period.\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:178.75pt;border-top:none;border-left:none;border-bottom:solid windowtext 1.0pt;border-right:solid windowtext 1.0pt;background:#FFC000;padding:0in 5.4pt 0in 5.4pt;height:40.8pt;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border:none;text-align:center;line-height:115%;'\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Calibri\",sans-serif;'\u003e62.8%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 99pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 40.8pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 205.55pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 40.8pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eThe number (%) of \u003cstrong\u003estaff\u003c/strong\u003e consenting to wearing the device and issued a device at any time during their study period.\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:178.75pt;border-top:none;border-left:none;border-bottom:solid windowtext 1.0pt;border-right:solid windowtext 1.0pt;background:#FFC000;padding:0in 5.4pt 0in 5.4pt;height:40.8pt;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border:none;text-align:center;line-height:115%;'\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Calibri\",sans-serif;'\u003e67.7%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 99pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 31.9pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eProvision of the intervention\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 205.55pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 31.9pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Times New Roman\",serif;color:black;border: none;line-height:115%;'\u003e\u003cspan style='font-size:13px;line-height:115%;font-family:\"Calibri\",sans-serif;'\u003eThe proportion of issued \u003cstrong\u003eresident\u003c/strong\u003e devices recording \u0026ldquo;correctly\u0026rdquo; during the study period.\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width:178.75pt;border-top:none;border-left:none;border-bottom:solid windowtext 1.0pt;border-right:solid windowtext 1.0pt;background:red;padding:0in 5.4pt 0in 5.4pt;height:31.9pt;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:center;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;color:black;\"\u003e29.17%\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 99pt;border-right: 1pt solid windowtext;border-bottom: 1pt solid windowtext;border-left: 1pt solid windowtext;border-image: initial;border-top: none;padding: 0in 5.4pt;height: 40.8pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eAcceptability of scheduled feedback report\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 205.55pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;padding: 0in 5.4pt;height: 40.8pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003eDemonstrated acceptability of outputs ascertained through manager interviews\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 178.75pt;border-top: none;border-left: none;border-bottom: 1pt solid windowtext;border-right: 1pt solid windowtext;background: black;padding: 0in 5.4pt;height: 40.8pt;vertical-align: top;\"\u003e\n \u003cp style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'\u003e\u003cspan style=\"font-size:13px;\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Discussion","content":"\u003cp\u003eA definitive trial of the CONTACT intervention using BLE wearables and feedback to homes for improved IPC decisions, at least in a pandemic context, was unfeasible. The intervention\u0026rsquo;s development, implementation, and evaluation were executed during the COVID-19 pandemic, a contextual factor that significantly reduced the feasibility of the intervention.\u003c/p\u003e \u003cp\u003eThe planning and development process was hastily executed, leading to a lack of proper adaptation for a care home context. For instance, BLE fob devices, required cleaning when exposed to human waste or food. More and longer co-produced planning could have allowed for better design adjustments.\u003csup\u003e26\u003c/sup\u003e Implementing CONTACT and study procedures was primarily carried out by the care homes, with minimal in-person support from the research team due to pandemic-related restrictions. They did not have the capacity for this implementation work.\u003c/p\u003e \u003cp\u003eWe used Normalisation Process Theory (NPT) for planning and implementation to mitigate some of these effects, but its utility was limited in the pressing circumstances of the pandemic.\u003csup\u003e27\u003c/sup\u003e The intervention demanded additional work from care homes already struggling with everyday care. CONTACT\u0026rsquo;s perceived benefits did not sufficiently outweigh pre-existing methods of IPC, limiting its appeal.\u003csup\u003e28\u003c/sup\u003e The idea of rectifying an information deficit through BLE wearable data and analysis only has merit if information does not come with too high a cost.\u003csup\u003e29\u003c/sup\u003e Like other aspects of health and social care, high quality tailored information does not always lead to informed choices.\u003csup\u003e30\u003c/sup\u003e The \u0026ldquo;pull\u0026rdquo; for the information we were \u0026ldquo;pushing\u0026rdquo;\u003csup\u003e31\u003c/sup\u003e was further diminished by the - albeit welcome - development of a successful vaccination programme for COVID-19.\u003c/p\u003e \u003cp\u003eTechnical issues were also a barrier. BLE wearables rely on RSSI signal strength to determine proximity and potential exposure. RSSI can be distorted by physical barriers or other device interference, reducing accuracy.\u003csup\u003e12,32,33\u003c/sup\u003e Further, real-world implementation issues led to suboptimal procedure compliance and low population coverage.\u003c/p\u003e \u003cp\u003eAs with others\u0026rsquo; experiences of tech-enabled contact tracing, privacy was a significant hurdle to implementation.\u003csup\u003e34\u003c/sup\u003e The tracking ability of the technology was seen as intrusive, undermining trust in the technology and IPC amongst staff. CONTACT was designed to offer insight into staff interaction times and movements. This ability to make staff \"visible\" deterred adoption. Australian care home research suggest limited interactions may make invisibility more desirable than is sometimes assumed.\u003csup\u003e35,36\u003c/sup\u003e Until such privacy concerns can be adequately addressed, the widespread use of wearable technology with tracking and tracing capabilities in care homes remains unlikely.\u003c/p\u003e \u003cp\u003eThe success of BLE wearables for contact tracing hinges on consistent use and device maintenance by individuals. In care homes, where many residents have cognitive and physical limitations, staff support is crucial. However, staff found the devices intrusive and burdensome. This crucial\u003csup\u003e28\u003c/sup\u003e lack of added value or perceived advantage reduced adoption: unwillingness to encourage residents to participate in the CONTACT study and wear the devices.\u003c/p\u003e \u003cp\u003eCONTACT faced a 12-month delay waiting for the permissions from the UK\u0026rsquo;s Social Care Research Ethics Committee to deliver CONTACT as part of \"care as usual\" - given the pandemic context. Despite gaining the required permissions, care homes insisted on individual consent procedures, citing fears of punitive action from the Care Quality Commission or litigation risks. These concerns, though unfounded, are indicative of a broader tendency to utilize administrative procedures to mitigate perceived risks - even if such actions might inadvertently compromise care quality.\u003csup\u003e37\u003c/sup\u003e They also reflect a wider failure to support care homes\u0026rsquo; research readiness; despite rhetoric from national research funders to the contrary.\u003csup\u003e38\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe movement of people into and between care homes was a significant factor in the spread of COVID-19.\u003csup\u003e39,40\u003c/sup\u003e The burden associated with the CONTACT study, staff restrictions, and infrastructural deficiencies made it impossible to extend the technology to visitors, thereby missing a key source of potential infection tracing.\u003c/p\u003e \u003cp\u003eAlthough we provided CONTACT\u0026rsquo;s technology to homes free-of-charge, there were associated costs such as data management, analysis, technical support for system installation, battery changes, and replacement devices. Given the perceived lack of value, it seems unlikely that care homes would be willing to absorb these costs or pass them onto the purchasers of care.\u003c/p\u003e \u003cp\u003eTo effectively utilise the information generated by BLE wearables staff need a degree of information literacy to understand concepts like individualized risk and infection trends. Limited numeracy and information skills can be a barrier to innovation in care homes.\u003csup\u003e41\u003c/sup\u003e Managers suggested CONTACT\u0026rsquo;s structured reporting used in CONTACT was difficult to comprehend, contributing to the perception that they were unlikely to use the information as a basis for change. This was compounded by a lack of trust in the results among some staff.\u003c/p\u003e \u003cp\u003eImplications for future research\u003c/p\u003e \u003cp\u003eCONTACT was unfeasible in a pandemic context. Nonetheless, digital contact tracing systems still have some promise; albeit based on low-quality evidence from modelling and simulation studies.\u003csup\u003e12,42\u003c/sup\u003e The implication is that effective implementation is a key determinant of successful contact tracing and improved Infection Prevention and Control (IPC), not the technical efficacy of BLE wearables.\u003csup\u003e33\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eFuture research involving BLE wearable systems should concentrate on applying known strategies for successful research with care homes \u003csup\u003e26\u003c/sup\u003e and dedicating time to co-produce BLE wearable systems that minimize the burden for participating homes. Facilitators such as privacy, trust, and the utilisation of valuable data from such systems should be a focus of planning and implementation phases.\u003c/p\u003e \u003cp\u003eAs with any new intervention, implementation failure revealed through evaluation is an essential part of learning and refinement. To maximize this learning, the use of appropriate theories of implementation, innovation adoption, and decision-making can ensure that failures contribute to broader literature and efficient intervention development. In this context, hybrid studies that combine an implementation focus with measuring effectiveness could yield the most valuable insights.\u003csup\u003e43\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eLimitations\u003c/p\u003e \u003cp\u003eCONTACT had several limitations. Firstly, not all staff and residents who wore the technology took part in feasibility assessment. Positive views of the intervention may have been missed. Additionally, key staff members involved in the study, notably the manager in Home 1, left during the feasibility assessment, destabilising the home and impacting study implementation.\u003c/p\u003e \u003cp\u003eAnother constraint was the limitation on the research team's presence in the care homes due to COVID-19 restrictions. Our development, implementation, and evaluation processes were largely conducted remotely and virtually; negatively impacting on these critical study aspects.\u003c/p\u003e \u003cp\u003eWith the easing of restrictions and more time to focus on building relationships during the development, delivery, and evaluation of an intervention, it is conceivable that a CONTACT-style intervention may prove more feasible in the future.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe CONTACT intervention of BLE wearables for contact tracing and feedback was unfeasible and unacceptable to care homes. Intervention planning, execution, and evaluation took place during the COVID-19 pandemic and coincided with the discovery of a successful vaccine against the disease. These factors influenced the research team's methodology and the care homes' willingness and ability to implement the intervention.\u003c/p\u003e \u003cp\u003eDespite these setbacks, the technology underpinning CONTACT shows promise. Consequently, future research is recommended, but with an important shift in focus: researchers should aim to co-design studies with care homes and place equal, if not greater, emphasis on the successful implementation of the intervention, rather than the technical effectiveness of the wearable devices.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBLE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBluetooth enabled\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003erandomised controlled trial\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRSSI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ereceived signal strength indicator\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNPT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNormalisation Process Theory\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNoMaD\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNormalisation Measure Development questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNHS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Health Services\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNIHR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Institute for Health and Social Care Research\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCONTACT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003e \u003cb\u003eCON\u003c/b\u003etact \u003cb\u003eT\u003c/b\u003er\u003cb\u003eA\u003c/b\u003ecing in \u003cb\u003eC\u003c/b\u003eare homes using digital \u003cb\u003eT\u003c/b\u003eechnology\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIPC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003einfection prevention and control\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSARS-CoV-2\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSevere acute respiratory syndrome coronavirus 2\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCOVID-19\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ecoronavirus disease\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIoT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInternet of Things\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eGPS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eglobal positioning system\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eLoRaWAN\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eLong Range Wide Area Network\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eENRICH\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eEnabling Research in Care Homes\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNICHE-Leeds\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNurturing Innovation in Care Home Excellence in Leeds\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCQC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCare Quality Commission\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCRF\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ecase report form(s)\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eCONTACT\u0026rsquo;s feasibility study and associated process evaluation received approval as part of the CONTACT study by the UK Health Research Authority (REC: 294390).\u003c/p\u003e\n\u003ch2\u003eConsent for publication\u003c/h2\u003e\n\u003cp\u003eAll images have been reproduced with permission from copyright holders.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials\u003c/h2\u003e\n\u003cp\u003eThe datasets generated and/or analysed during the current study are not publicly available as data contains sensitive information for residents and families of the homes and we cannot rule out the possibility that those close to the homes may think they recognise certain aspects of context. Anonymised Social Network data on contact patterns for four homes are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003ch2\u003eCompeting interests\u003c/h2\u003e\n\u003cp\u003eDuring the COVID-19 pandemic \u003cstrong\u003eCN\u003c/strong\u003e and \u003cstrong\u003eAG\u003c/strong\u003e were participants in the UK Scientific Advisory Group for Emergencies (SAGE), co-chaired the SAGE Environment and Modelling Sub-Group and was a member of the SAGE care home working group. \u003cstrong\u003eCT\u003c/strong\u003e has previously provided paid scientific advice to Microshare Ltd and has presented to the SAGE care home working group.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eContact Tracing in Care Homes Using Digital Technology (CONTACT) study was commissioned as part of the UK National Institute for Health and Care Research\u0026apos;s (NIHR) COVID-19 Recovery and Learning call in April 2020.49\u0026nbsp;It is funded by the NIHR [HTA programme (NIHR132197)].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.\u003c/p\u003e\n\u003ch2\u003eAuthors\u0026apos; contributions\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eCT\u003c/strong\u003e was CONTACT\u0026rsquo;s principal investigator, led the design of the study and writing the paper and takes overall responsibility for content. \u003cstrong\u003eADO\u003c/strong\u003e led on conduct of the process evaluation, data collection and qualitative analysis. \u003cstrong\u003eAF\u003c/strong\u003e oversaw quantitative analysis. \u003cstrong\u003eKK, CN\u003c/strong\u003e and \u003cstrong\u003eAK\u003c/strong\u003e led the technical evaluation of the CONTACT BLE wearable system performance and. \u003cstrong\u003eCB\u0026nbsp;\u003c/strong\u003eoversaw economic aspects of CONTACT and helped design various aspects of the study. \u003cstrong\u003eAG\u003c/strong\u003e and \u003cstrong\u003eTH\u003c/strong\u003e were major contributors to the planning of CONTACT and the clinical dimensions of infection prevention and control. \u003cstrong\u003eTW\u003c/strong\u003e oversaw manuscript production and was a major contributor to writing the manuscript. \u0026nbsp;\u003cstrong\u003eKS\u003c/strong\u003e was a major contributor to the mixed method analysis, interpretation and discussion of results. All authors helped shape the design of the evaluation and structure and presentation of the findings, read and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eAcknowledgements\u003c/h2\u003e\n\u003cp\u003eWe would like to thank Aliah Sagar, Adam Barret; Bonny Cundell; Suzanne Hartly; Amanda Lilly Kelly Ellen Mason and Maree Chaney and other Leeds CTRU staff for their research contributions at various points in the CONTACT study. We would also like to thank the staff and residents of the four care homes involved in the study our study steering committee and PPI members for their valuable oversight and guidance. Finally, our industry partner, Microshare.inc, who provided technology and advice who fairly, flexibly and reasonably adapted their systems to the needs of the homes and research team. \u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eOffice for National Statistics. 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Effects of chain ownership and private equity financing on quality in the English care home sector: retrospective observational study. \u003cem\u003eAge Ageing\u003c/em\u003e \u003cstrong\u003e51\u003c/strong\u003e, afac222 (2022).\u003c/li\u003e\n \u003cli\u003e[Withdrawn] Guidance to assist professionals in advising the general public. \u003cem\u003eGOV.UK\u003c/em\u003e https://www.gov.uk/government/publications/novel-coronavirus-2019-ncov-guidance-to-assist-professionals-in-advising-the-general-public/guidance-to-assist-professionals-in-advising-the-general-public (2020).\u003c/li\u003e\n \u003cli\u003eFinch, T. L. \u003cem\u003eet al.\u003c/em\u003e Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). \u003cem\u003eBMC Med. Res. Methodol.\u003c/em\u003e \u003cstrong\u003e18\u003c/strong\u003e, 135 (2018).\u003c/li\u003e\n \u003cli\u003eLancaster, G. A., Dodd, S. \u0026amp; Williamson, P. R. Design and analysis of pilot studies: recommendations for good practice. \u003cem\u003eJ. Eval. Clin. Pract.\u003c/em\u003e \u003cstrong\u003e10\u003c/strong\u003e, 307\u0026ndash;312 (2004).\u003c/li\u003e\n \u003cli\u003eParticipation, E. Mental Capacity Act 2005. https://www.legislation.gov.uk/ukpga/2005/9/contents.\u003c/li\u003e\n \u003cli\u003eBunn, F. \u003cem\u003eet al.\u003c/em\u003e Setting Priorities to Inform Assessment of Care Homes\u0026rsquo; Readiness to Participate in Healthcare Innovation: A Systematic Mapping Review and Consensus Process. \u003cem\u003eInt. J. Environ. Res. Public. Health\u003c/em\u003e \u003cstrong\u003e17\u003c/strong\u003e, 987 (2020).\u003c/li\u003e\n \u003cli\u003eMay, C. R. \u003cem\u003eet al.\u003c/em\u003e Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. \u003cem\u003eImplement. 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Hyg.\u003c/em\u003e \u003cstrong\u003ein press\u003c/strong\u003e, (2023).\u003c/li\u003e\n \u003cli\u003eA cross-country comparison of contact-tracing apps during COVID-19. \u003cem\u003eCEPR\u003c/em\u003e https://cepr.org/voxeu/columns/cross-country-comparison-contact-tracing-apps-during-covid-19 (2021).\u003c/li\u003e\n \u003cli\u003eEdwards, H. \u003cem\u003eet al.\u003c/em\u003e Resident-staff interactions: a challenge for quality residential aged care. \u003cem\u003eAustralas. J. Ageing\u003c/em\u003e \u003cstrong\u003e22\u003c/strong\u003e, 31\u0026ndash;37 (2003).\u003c/li\u003e\n \u003cli\u003eSaldert, C., Bartonek-\u0026Aring;hman, H. \u0026amp; Bloch, S. Interaction between Nursing Staff and Residents with Aphasia in Long-Term Care: A Mixed Method Case Study. \u003cem\u003eNurs. Res. 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W. \u003cem\u003eet al.\u003c/em\u003e Barriers and facilitators to implementing dementia care mapping in care homes: results from the DCM\u003csup\u003eTM\u003c/sup\u003e EPIC trial process evaluation. \u003cem\u003eBMC Geriatr.\u003c/em\u003e \u003cstrong\u003e19\u003c/strong\u003e, 37 (2019).\u003c/li\u003e\n \u003cli\u003eAnglemyer, A. \u003cem\u003eet al.\u003c/em\u003e Digital contact tracing technologies in epidemics: a rapid review. \u003cem\u003eCochrane Database Syst Rev\u003c/em\u003e \u003cstrong\u003e8\u003c/strong\u003e, CD013699 (2020).\u003c/li\u003e\n \u003cli\u003eCurran, G. M., Bauer, M., Mittman, B., Pyne, J. M. \u0026amp; Stetler, C. Effectiveness-implementation Hybrid Designs. \u003cem\u003eMed. Care\u003c/em\u003e \u003cstrong\u003e50\u003c/strong\u003e, 217\u0026ndash;226 (2012).\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Footnotes","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003e Residential care homes, offer a safe environment for support with personal care, like dressing and washing, activities and opportunities for socialising.\u003c/span\u003e\u003cdiv id=\"Par62\" class=\"Para\"\u003eAlongside opportunities for socialising, nursing homes provide registered nursing care for those with higher levels of care need (for example, post hospital discharge or with long-term care needs arising from conditions such as dementias). nursing homes have a qualified nurse on site round-the-clock, supported by care assistants, so they can provide a higher level of care.\u003c/div\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Digital contact tracing, care homes, Bluetooth enabled wearables, long term care, feasibility, COVID-19’, complex interventions.","lastPublishedDoi":"10.21203/rs.3.rs-3242598/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3242598/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e The need for effective non-pharmaceutical infection prevention measures such as contact tracing in pandemics remains in care homes, but traditional approaches to contact tracing are not feasible in care homes. The CONTACT intervention introduces Bluetooth Enabled wearable devices (BLE wearables) as a potential solution for automated contact tracing. Using structured reports and reports triggered by positive COVID-19 cases in homes we fed contact patterns and trends back to homes to support better-informed infection prevention decisions and reduce blanket application of restrictive measures. This paper reports on the evaluation of feasibility and acceptability of the intervention and a planned definitive cluster randomised trial of the CONTACT BLE wearable intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e CONTACT was a non-randomised mixed-method feasibility study over two months in four English care homes. Recruitment was via care home research networks, with individual consent. Data collection methods included routine data from the devices, case report forms, qualitative interviews (with staff and residents) and field observation of care and an adapted version of the NoMaD survey instrument to explore implementation using Normalisation Process Theory. Quantitative data were analysed using descriptive statistical methods. Qualitative data was thematically analysed using Normalisation Process Theory. Intervention and study delivery were evaluated against predefined progression criteria.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Of 156 eligible residents, 105 agreed to wear a device, with 102 (97%) starting the intervention. Of 225 eligible staff, 82.4% (n=178) participated. Device loss and damage were significant: 11% of resident devices were lost or damaged, ~50% were replaced. Staff lost fewer devices, just 6.5%, but less than 10% were replaced. Fob wearables needed more battery changes than card-type devices (15% vs. 0%). Structured and reactive feedback was variably understood by homes but not likely to be acted on. Researcher support for interpreting reports was valued. Homes found information useful when it confirmed rather than challenged preconceived contact patterns. Staff privacy concerns were a barrier to adoption. Study procedures added to existing work, making participation burdensome. Study participation benefits did not outweigh perceived burden and was amplified by the pandemic context. CONTACT did not meet its quantitative or qualitative progression criteria.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e CONTACT found a large-scale definitive trial of BLE wearables for contact tracing and feedback-informed IPC in care homes unfeasible and unacceptable - at least in the context of shifting COVID-19 pandemic demands. \u0026nbsp;Future research should co-design interventions and studies with care homes, focusing more on successful intervention implementation than solely on technical effectiveness.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eISRCTN registration\u003c/strong\u003e: 11204126 registered 17/02/2021\u003c/p\u003e","manuscriptTitle":"CONTACT: A Non-Randomised Feasibility Study of Bluetooth Enabled Wearables for Contact Tracing in UK Care Homes During the COVID-19 Pandemic.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-10-12 19:36:17","doi":"10.21203/rs.3.rs-3242598/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2024-04-16T20:20:33+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2024-04-12T06:19:56+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2023-10-07T02:22:31+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-08-29T06:05:39+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2023-08-08T04:33:05+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f8868eb3-5fa4-4a1b-b654-ad4e3b0a033f","owner":[],"postedDate":"October 12th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-10-07T16:03:21+00:00","versionOfRecord":{"articleIdentity":"rs-3242598","link":"https://doi.org/10.1186/s40814-024-01549-6","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2024-10-02 15:57:50","publishedOnDateReadable":"October 2nd, 2024"},"versionCreatedAt":"2023-10-12 19:36:17","video":"","vorDoi":"10.1186/s40814-024-01549-6","vorDoiUrl":"https://doi.org/10.1186/s40814-024-01549-6","workflowStages":[]},"version":"v1","identity":"rs-3242598","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3242598","identity":"rs-3242598","version":["v1"]},"buildId":"J0_U0BvcaRcwD8yVFaRlm","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}