Evaluating The Feasibility of Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE) in Community Group Settings

Evaluating The Feasibility of Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE) in Community Group Settings | 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 Evaluating The Feasibility of Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE) in Community Group Settings Linda Elizabeth O'Raw, Becky Dowson, Martin Orrell, Orii McDermott, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5198553/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 4 You are reading this latest preprint version Abstract Background Community singing interventions have been explored as potential therapeutic activities for people with dementia and their carers. This feasibility study aimed to evaluate the practicality, engagement, and preliminary outcomes of such an intervention. Methods A total of 72 participants (36 dyads) were recruited across three sites, achieving 45% of the target sample size. Participants were randomly assigned to an intervention group, which engaged in community singing sessions, or a waiting list control group. Demographic characteristics were balanced between groups, and baseline musical engagement was low. Recruitment challenges and varying site fidelity were noted. Results The intervention demonstrated high feasibility, with patient reported outcome measures being practical and successfully administered. Despite a lack of statistically significant differences in patient reported outcome measures due to the small sample size, slight improvements were observed in quality of life, well-being, and daily activities within the intervention group. Retention rates were good, although slightly higher in the control group. Notably, post-intervention, all sites transitioned to independent community singing groups or secured funding for continued activities, indicating strong participant engagement and perceived value. Conclusions The study highlights the potential benefits of community singing interventions for people with dementia and their carers, suggesting improvements in quality of life and well-being. However, challenges such as recruitment and control condition engagement must be addressed in future research. Larger sample sizes and extended follow-up periods are necessary to confirm the intervention’s effectiveness and to explore its long-term impact. Trial Registration: Funded by NIHR Research for Patient Benefit – Social Care (NIHR202982) and has been registered with ISRCTN (10201482) and IRAS (Project ID: 313298). The University of Nottingham is the trial sponsor. Community singing dementia feasibility study intervention quality of life participant engagement Figures Figure 1 Key messages regarding feasibility What uncertainties existed regarding the feasibility? The study highlighted challenges with recruitment, site fidelity, control group engagement, and uncertainties around long-term sustainability, all of which could impact the reliability and scalability of the intervention. What are the key feasibility findings? The study demonstrated the feasibility of implementing the intervention, with high engagement, practical outcome measures, potential benefits to quality of life, and evidence of sustainability through independent continuation of activities. What are the implications of the feasibility findings for the design of the main study? The findings highlight the need for enhanced recruitment strategies, standardized intervention fidelity measures, practical outcome assessments with larger samples and extended follow-up, and an embedded sustainability plan to support long-term implementation across varied settings. Background Community-based interventions are vital for improving the social, emotional, and practical aspects of life for people with dementia and their carers, helping them navigate the challenges of the condition more effectively (Baker et al., 2023 ; Harding et al., 2021 ; Veal et al., 2022 ; Whitlatch and Orsulic-Jeras, 2018 ). Community-based music interventions provide opportunities for social interaction, reducing feelings of loneliness and fostering a sense of belonging, (Coulton et al., 2015 ; Freedman and Nicolle, 2020 ) including singing groups online (Dowson et al., 2023 ). Further, engaging in meaningful activities is thought to support cognitive function and emotional health (Baker et al., 2023 ) while addressing agitation (Veal et al., 2023). Moreover community-based music interventions help integrate people with dementia into societal activities, challenging stigma and promoting a more inclusive and dementia-friendly environment (Baker et al., 2023 ; Tamplin et al., 2023). Interventions involving people with dementia and their carers in community singing activities may empower them to remain active and engaged, fostering a sense of purpose and autonomy (Baker et al., 2023 ; Tamplin et al., 2023, Osman et al., 2016 ). Existing evidence comes from small studies and is inconsistent, with some reporting no changes in standardized measures of quality of life, mood, or neuropsychiatric symptoms of dementia, despite positive qualitative findings (Baker et al., 2023 ; Dorris & Rodakowksi, 2024; Dowson et al., 2019 ). Reliable evidence of benefit could inform social care strategy, attract additional funding for group singing initiatives, broaden options for social prescribers, and potentially alleviate pressure on health and social care services by enhancing the resilience of those with dementia and their caregivers in the community. Consequently, there is a need for rigorous, randomized controlled trial evidence to measure the effects of group singing on individuals with dementia and their caregivers. This feasibility study seeks to evaluate the practicality of implementing community singing groups and explore their potential impact on the quality of life and the emotional, cognitive, and social well-being of both people with dementia and their carers. Aim The purpose of the Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE) study was to test the feasibility of conducting a pragmatic, randomized trial of community singing in dementia with a waiting list control group. The key feasibility indicators were recruitment, retention after three months, and the acceptability of the waiting-list control trial design to participants. The secondary objective of the study was to examine the impact of group singing on people with dementia and their carers, using a range of standardised patient reported outcome measures, including quality of life and well-being. Methods & Design The study was a two-arm, randomised controlled, feasibility trial of community group singing using a waiting list control. Each dyad, consisting of a main participant (person with dementia) and a secondary participant (carer) was randomised into a control arm or intervention arm. The control arm waited up to 12-weeks before beginning singing sessions whereas the intervention arm joined the singing session immediately post-baseline measures, for a minimum 10-week period. The study was carried out in three sites in the East Midlands of England. For anonymity, they are referred to as sites A, B, and C. In keeping with the study design, a range of patient reported outcome measures (PROM) were used that reflected the wellbeing of the person with dementia and the care partner, as well as the relationship of this dyad. This battery was informed by the results of a study of online singing during the COVID pandemic (Dowson & Schneider, 2023). We also included measures of cognition to monitor disease progression, although we did not hypothesise that singing would be a disease-modifying intervention; rather, we predicted that its main effect would be on quality-of-life measures. PROMs were measured at baseline (T0), three months post-baseline (T1) and six months post-baseline (T2) and completed within the home of the person with dementia. Control arm participants were offered singing intervention sessions at T1. Hence, all participants, regardless of randomised arm, had access to singing between months 3 and 6 of the study. Demographic data (age, sex, ethnicity, education, musical/singing experience) were collected at T0. PROMs used included instruments to assess of quality of life (DEMQOL/DEMQOL Proxy; Smith et al., 2007 ), social independence (Engagement and Independence in Dementia Questionnaire; Stoner et al., 2017), dementia specific outcomes (Dementia Core Outcome Set; Reilley et al., 2020), loneliness (Three-item Loneliness Scale; Hughes et al., 2003), musical engagement (Musical Engagement Questionnaire 15-item version; Vanstone et al., 2016), wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale; Tennant et al., 2007 ), depression (Geriatric Depression Scale; Yesavage et al., 1982), and cognition (Mini Mental State Examination; Folstein et al., 1975). At baseline, PROMs were collated per dyad. They took approximately two hours to complete. Post baseline, two researchers and delivery staff who were ‘blind’ to condition were assigned to administer the PROMs. This worked well and reduced the time taken to complete all PROMs. Participants Participants who lacked capacity to provide informed consent at recruitment were excluded to ensure ethical integrity. Consent was treated as an ongoing process, with continuous monitoring of participants' capacity. When a participant’s capacity deteriorated, a consultee was appointed to provide guidance on their continued involvement. If the participant or consultee expressed a wish to withdraw, participation was promptly terminated, retaining the data collected to date, ensuring the study remained ethically sound and voluntary. Other exclusion criteria included significant hearing impairments ; simultaneous participation in other interventional studies; and history of severe mental illness, alcohol or drug addiction. At the start of the project, which impacted the first site only, participants with dementia who had been in other singing groups in the past 6 weeks were excluded from the study. However, due to slow recruitment and given that the study’s purpose was to test feasibility criteria rather than outcomes for participants, a substantial amendment was made in February 2023 to include participants who had engaged with singing within the past 6 weeks. The inclusion criteria for people with dementia were: a formal diagnosis of mild to moderate dementia; being at least 18 years old; and having a carer who spent more than two hours per week with them. To be included, participants also had to be willing to join a singing group and attend weekly; be able to give informed consent; and be able to speak English. Similarly, carers were required to speak and understand English; to be willing to give informed consent; and to be willing, in principle, to attend the singing group regularly for at least 10 weeks. Intervention Preliminary online singing sessions following a similar intervention protocol were conducted during the COVID pandemic, delivering 30 sessions. Through this experience, the research team gained insights into the effective balance of warm-up exercises, conversation, and singing and refined the intervention protocol for PRESIDE (Dowson et al,, 2021). For the present (face to face) study, three experienced community singing group leaders were recruited to run the sessions. They were provided with a guidance manual (see supplementary material) that describes the essential and optional elements of the intervention, while leaving them free to use their skills and experience (cf. Gold et al., 2019 ). A song book was produced to support the sessions, but it was not compulsory. Singing sessions ran for 120 minutes (approximately 30 minutes of gentle exercise and vocal warm-ups, 60 minutes singing familiar and new songs or talking about music, and intermittent breaks accumulating to another 30 minutes). Fidelity scales for the intervention (see supplementary material) were administered at the start and again at 8 and 16 weeks. Participants randomised to start singing sessions right away were asked to attend weekly for 10 weeks. After this time, they could continue with the group if they wished, and the participants in the control arm joined the sessions. Sample Size The target sample size was 160 participants or 80 dyads, forty in each arm. It was calculated that a full trial with quality of life as its main PROM would need to recruit 360 analysable pairs and yield 80% power of achieving statistical significance at 5% level with 2-sided test if effect size ∆ = 0.3 (small). The 2-arm equal-allocation feasibility trial aims to justify full trial but achieve significance only if ∆ exceeds 0.65 (large). Randomisation and ‘blinding’ Participants were stratified based on age with minimisation by age (+/- 80), sex and experience of singing, and computerised randomisation was performed in each stratum, so that it is weighted to account for these critical factors. This process was competed by LH. The trial statistician (LW) and research staff administering 3 months (T1) and 6 months (T2) PROMs remained unaware of study arm allocation until analysis was complete. Research staff managing the project (BD, LO) were aware of study arm allocation because they attended singing sessions and conducted qualitative interviews. Recruitment The study was open to recruitment from October 2022 to June 2023. Each site had approximately three months to recruit prior to the first singing session starting. In total 30 weeks of the singing was provided to maximise on the window of opportunity available to recruit participants who could complete their 10-week intervention within this period. Potential participants were screened over the telephone and pre-assessment home visits were arranged. Extensive recruitment efforts included advertising with social prescribers, engagement with Local Authorities and District Councils, distribution in day centres, visits to local GP surgeries, dementia cafes, post offices, pharmacies, libraries, and local television appearances. The ‘Join Dementia Research’ database was accessed to identify suitable participants in each local region ( http://www.joindementiaresearch.nihr.ac.uk ). Statistical Analysis The aim of the statistical analysis was to assess: the heterogeneity of the sample, retention rates in each arm of the study, and the performance of the PROMs in terms of their acceptability and validity, judged by missing data, as well as their apparent sensitivity to change, judged by variability and change over time. The statistician (LW) therefore generated descriptive data, summarizing demographic and PROM, with mean and standard deviation (SD) for normally distributed variables; median and interquartile ranges (IQR) for skewed variables; frequency and percentages (%) for categorical variables. These data were analysed by study arm at baseline, T1 (3 months) and T2 (6 months). Confidence intervals were reported to convey precision of estimates as the feasibility was not powered to detect effects. Results Demographic Characteristics The intervention and control arms were similar in age and ethnicity, with balanced demographic representation across both study arms on most variables (Table 1 ). The majority of the participants were White British. Table 1 Sample Characteristics Baseline Randomisation Characteristics Baseline: Person with Dementia Baseline: Carer INT Control INT Control N n = 18 n = 18 n = 18 n = 18 Age, years Mean (SD) 77.3 (7.4) 75.9 (8.7) 67.5 (11.6) 68.8 (9.5) Sex n (%) 5 (27.8) 8 (44.4) 26 (72.2) 12 (66.7) Ethnicity n (%) White 18 (100) 18 (100) 17 (94.4) 18 (100) Relationship n (%) Spouse/partner 15 (83.3) 13 (72.2) Child 2 (11.1) 4 (22.2) Friend / other 1 (5.6) 1 (5.6) INSERT Table 1 Recruitment The target of 160 participants (80 dyads) was not achieved. Despite strenuous recruitment efforts over more than eight months, only 45% of the target sample was achieved: 72 participants (36 dyads ) consented across three sites, A (n = 28; 14 dyads), B (n = 22; 11 dyads), and C (n = 22; 11 dyads) (see Fig. 1 ). INSERT FIGURE 1 Prior Singing Experience Most participants (77.8%) indicated that had ‘none’ or ‘not much’ prior singing experience (14 participants in both INT and Control arms). 22.3% indicated that they had ‘quite a lot’ or ‘extensive’ singing experience (4 participants in both INT and Control arms). Prior musical engagement was further measured via the Musical Engagement Questionnaire, for both the intervention and control arms. This showed MusEQ mean score (± SD) of 35.4 (6.7) in the intervention arm and 34.9 (7.2) in the control arm indicated a relatively low engagement with music prior to the study commencing. Retention The retention rate at T1 (primary end point) was 78% in both arms. At T2, participant retention was lower in the intervention group (66.7%) than in the control group (77.8%). As shown in Fig. 1 , the number of participants who withdrew were 22.2% in both the intervention and control arms. Attendance Across all sites, 77.8% participants attended 5 or more sessions (50%) in the intervention group compared with 55% participants in the control arm. This includes 33% of participants in the control arm (waiting list) that attended no community singing sessions, compared to 6% of the intervention arm. Singing Session Fidelity Table 3 shows Fidelity Checklist Adherence across three sites (A, B, and C). Higher percentages indicate fidelity to the intended model. Site A showed the highest adherence (86.3%) and Site B showed the lowest (65.61%). Overall, a high adherence to fidelity rate was achieved, observing a mean 78.8% across all sites (see Table 2 ). Table 2 Fidelity Checklist Adherence by Site % Fidelity Checklist Adherence Facilitator Site A Site B Site C Item Mean % Essential Session Components Welcome and check in 100 100 100 100 Physical warm up 100 100 83.3 94.4 Vocal warm Up 100 100 87.5 62.5 Opening song 0 12.5 62.5 58.3 Singing familiar songs 100 100 100 100 Song choices offered 95.2 9.4 100 68.2 Closing song 95.2 3 41.6 46.6 Refreshments 100 100 100 100 Totals 86.3 65.61 84.36 78.75 Table 3 Three Month Outcome Measures for People with Dementia and Carers 3 Month Outcome Measures for People with Dementia (T0-T1) 3 Month Outcome Measures for Carers (T0-T1) Variable INT (n = 14) Control (n = 14) aMD (95% CI) INT (n-13) Control (n = 14) aMD (95% CI) Mean (+/- SEM) Mean (+/- SEM) DEMQOL 100.2 (10.1) 94.9 (13.1) 0.38 (-6.91, 7.67) DEMQOL-PROXY 97.1 (14.9) 91.1 (10.7) 2.29 (-6.42, 11.00) EID-Q: ...Activities of Daily Living 18.3 (1.8) 17.3 (4.1) 1.11 (-1.12, 3.35) ...Decision Making 13.1 (2.0) 11.7 (2.5) 1.25 (-0.29, 2.79) ...Activity Engagement 10.5 (1.4) 8.9 (2.2) 1.22 (-0.30, 2.74) ...Support 24.8 (3.1) 24.5 (2.9) -0.12 (-2.58, 2.34) …Reciprocity 19.2 (3.7) 18.0 (4.6) 1.03 (-2.02, 4.08) Dementia core outcome set 37.1 (2.4) 36.0 (3.3) 0.81 (-1.25, 2.87) MMSE-brief 8.7 (3.1) 10.1 (3.5) -0.64 (-2.47, 1.18) Three-item loneliness scale 3.8 (1.4) 4.1 (1.5) -0.12 (-1.04, 0.80) 4.8 (1.8) 4.5 (1.7) 0.67 (-0.23, 1.56) EQ-5D-5L HSUV 0.86 (0.26) 0.82 (0.16) 0.03 (-0.13, 0.19) 0.81 (0.17) 0.73 (0.23) 0.05 (-0.08, 0.18) EQ-VAS 66.5 (15.9) 66.8 (12.2) -1.07 (-11.4, 9.29) 75.0 (19.8) 75.9 (17.7) 5.07 (-5.86, 16.00) Geriatric depression scale, GDS 1.3 (1.9) 3.3 (3.3) -0.42 (-2.47, 1.63) 4.3 (2.9) 3.1 (2.3) 1.04 (-0.70, 2.78) SWE Mental Wellbeing scale 56.6 (7.9) 53.2 (8.0) 2.84 (-2.54, 8.22) 48.7 (8.9) 52.4 (7.5) -1.87 (-6.97, 3.24) SIDECAR …(D) Direct impact 9.5 (5.2) 8.0 (3.8) 0.26 (-2.04, 2.56) …(I) Indirect impact 6.2 (2.1) 6.3 (2.8) 0.58 (-0.85, 2.01) …(S) Support and information 5.8 (2.7) 6.5 (2.6) -0.36 (-2.04, 1.32) INSERT Table 2 Patient Report Outcome Measures (PROMs) The intervention and control arms did not differ significantly on any PROM. Table 3 shows the mean scores and standard deviations, 95% confidence intervals for the outcome measures at T1 (3 months) for people with dementia and carers, respectively. INSERT Table 3 Treatment effects were assessed at T1 using adjusted Mean Differences (aMD) with 95% Confidence Intervals (CI) (Table 3 ). The largest observed effect was for DEMQOL, with an aMD of 0.38 (positive effect). For the intervention group, scores increased from 95.7 to 100.2 between baseline and T1 (aMD = -4.43, 95% CI: -13.1 to 4.19). A similar slight increase was observed in the waiting list control group, with scores rising from 94.9 to 98.4 (aMD = -3.50, 95% CI: -12.3 to 5.3). This pattern was also reflected in the DEMQOL-Proxy scores (see Table 3 ). For people with dementia, Table 4 suggests that group community singing sessions had a positive impact in the intervention group on decision-making abilities (aMD = -2.90, 95% CI: -5.31, -0.49), reciprocity in relationships (aMD = -3.41, 95% CI: -6.72, -0.09), and mental well-being (aMD = -6.76, 95% CI: -13.2, -0.29). Comparatively, no significant differences were observed in the waiting list control group for decision-making abilities, reciprocity, or mental well-being (95% CI not overlapping). Table 4 Post Singing Session Comparisons Between intervention and Control Groups for People with Dementia Variable INT Baseline v 3 Months (T0vT1) Control 3 months v 6 Months (T1vT2) Baseline (n = 18) 3 months (n = 14) aMD (95% CI) 3 months (n = 14) 6 months (n = 14) aMD (95% CI) DEMQOL 95.7 (14.0) 100.2 (10.1) -4.43 (-13.1, 4.19) 94.9 (13.1) 98.4 (11.3) -3.50 (-12.2, 5. 23) DEMQOL-PROXY 91.8 (17.5) 97.1 (14.9) -5.29 (-17.9, 7.30) 91.1 (10.7) 96.8 (14.9) 5.75 (-16., 4.73) EID-Q: ...Activities of Daily Living 16.7 (5.1) 18.3 (1.8) -1.6 (-4.44, 1.24) 17.3 (4.1) 17.3 (3.3) 0.05 (-2.68, 2.78) ...Decision Making 10.2 (4.2) 13.1 (2.0) -2.90 (-5.31, 0.49) 11.7 (2.5) 11.2 (3.5) 0.50 (-1.67, 2.67) ...Activity Engagement 9.3 (2.7) 10.5 (1.4) -1.17 (-2.73, 0.40) 8.9 (2.2) 9.1 (2.0) -0.21 (-1.74, 1.31) ...Support 22.9 (4.5) 24,8 (3.1) -1.89 (-4.67, 0.89) 24.5 (2.9) 24.7 (3.2) -0.18 (-2.40, 2.05) …Reciprocity 15.8 (5.4) 19.2 (3.7) -3.41 (-6.72, -0.09) 18.0 (4.6) 19.1 (4.0) -1.07 (-4.14, 1.99) MMSE-brief 8.6 (3.5) 8.7 (3.1) -0.08 (-2.37, 2.21) 10.1 (3.5) 10.2 (3.7) -0.07, (-2.66, 2.52) Three-item loneliness scale 4.1 (1.4) 3.8 (1.4) 0.35 (-0.60, 1.30) 4.1 (1.5) 3.9 (1.4) 0.21 (-0.80, 1.23) Dementia core outcome set 34.7 (4.8) 37.1 (2.4) -2.37 (-5.13, 0.39) 36.0 (3.3) 36.9 (1.8) -0.92 (-2.89, 1.05) EQ-5D-5L HSUV 0.85 (0.19) 0.86 (0.26) -0.01 (-0.16, 0.14) 0.82 (0.16) 0.83 (1.8) -0.01 (-0.12, 0.10) EQ-VAS 75.8 (18.2) 66.5 (15.9) 9,29 (-2,61, 21.20) 66.8 (12.2) 66.1 (19.7) 0.64 (-11.1, 12.34) Geriatric depression scale, GDS 2.5 (2.6) 1.3 (1.9) 1.14 (-0.54, 2.81) 3.3 (3.3) 2.9 (3.4) 0.42 (-2.17, 3.01) SWE mental wellbeing scale 49.8 (9.8) 56.6 (7.9) -6.76 (-13.2, -0.29) 53.2 (8.0) 53.7 (8.5) -0.48 (-6.47, 5.51) INSERT Table 4 Discussion The data gathered indicate that it was feasible to collect these PROMs from both people with dementia and their carers. Both people with dementia and carers were able to complete the assessments and measures without major issues. Whilst there was a lack of significant differences observed within and between groups, and no strong trends emerged, there were slight improvements in quality of life, well-being and daily activities for people with dementia in the intervention group. These findings suggest that the intervention could potentially have positive effects, but more participants and a longer follow-up period are needed to confirm such benefits. The demographic profiles of the intervention and control arms were well-matched, with age and ethnicity being balanced across both groups. Predominantly, participants were White British, reflecting a relatively homogeneous sample in terms of ethnic background. This similarity ensures that demographic factors are unlikely to have introduced bias into the study’s outcomes. Singing experience and the Musical Engagement Questionnaire, indicated that participants generally had relatively low levels of engagement with singing prior to starting the study. This feasibility study provides valuable insights into the impact of community singing interventions for people with dementia and their carers, but several limitations must be acknowledged. Firstly, the recruitment process presented challenges despite removing the exclusion criteria that prevented participants from joining with previous group singing experience. We found that using the Join Dementia Research database proved to be the most effective method of recruitment (Join Dementia Research, n.d. ). The slow rate of recruitment aligns with findings from other studies in this area (Baker et al., 2023 ; Veal et al., 2022 ). Other barriers to recruitment may include psychosocial, geographical, logistical, stigma-related and financial impediments. For example, recruitment took place following lockdown restrictions from the COVID-19 pandemic, which could have discouraged participants (Docherty et al., 2021 ). Closer analysis of the pandemic’s impact on this study is undertaken in [paper in preparation]. . Recruitment remains a serious issue as under-recruitment limits sample size, which limits the statistical power of the study. This could have resulted in a Type 2 error, failing to show any statistical significance. Therefore, future studies could benefit from extending the recruitment timeframe and increasing the number of singing sessions to enable the recruitment target to be reached. The waiting-list control design was broadly accepted, indeed the control-arm participants demonstrated staying power in completing more of their intervention sessions. However, drop-out was higher in the control arm, and these findings suggest that simply being on a waiting list without active participation may result in diminished motivation and interest among participants (Coulton et al., 2015 ; Veal et al., 2022 ). Retention in both arms was, overall, good, although higher retention rates were observed in the control group. When investigating further, outside factors, such as the complexities of living with dementia could be attributed to drop out rather than the impact of the intervention itself. The slight changes in retention rates between intervention and control arms do not adequately reflect the sustainability of the community singing intervention. The study achieved high fidelity rates overall, showing many strong components (such as "Welcome and Check-in," "Singing Familiar Songs," "Refreshments"). Sites differed somewhat in “Song Choices Offered” and using an "Opening Song” or a "Closing Song”. It remains unclear if such differences between sites are likely to influence the intended PROMs but this is a question which future studies could address. Post intervention, self-sustainability was observed across all sites in various ways. Our study showed one site transitioned to an independent singing group for people with dementia and their carers, managed by a charitable organisation, retaining its membership base who took responsibility for the breaktime drinks and snacks. Another site secured external funding with a national charity to continue singing activities for individuals with dementia and their carers. Our final site did not continue as a group, but all participants joined other local singing groups with the exception of two dyads; one dyad has started their own singing group in a care home whilst the other dyad is seeking something a little more local to them. This enduring engagement suggests that the participants found significant value and enjoyment in the sessions, which contributed to their continued participation beyond the study’s formal end. In addition to the potential cost-effectiveness, the self-sustainability of these groups indicates that a high level of acceptability and perceived benefit among the participants, indicating that community singing interventions foster lasting community engagement and personal satisfaction. This study supports community singing as a potentially effective and efficient intervention to improve the quality of life for people with dementia and their carers, and our results should be taken into account in future trials. Conclusion This feasibility study has provided meaningful insights into the potential benefits and challenges associated with community singing interventions for people with dementia and their carers. The findings indicate that, while the intervention may offer positive effects on quality of life, well-being, and daily activities, the small sample size and various limitations remain to be addressed in future research. The PRESIDE study has demonstrated the feasibility of the measures used and the acceptability of the intervention, with high retention rates. It also showed high fidelity to key intervention components. The observed self-sustainability of the singing groups post-intervention further supports the intervention's potential for long-term impact and community engagement. However, the challenges of recruitment and control condition design, highlight areas for improvement. Future studies should aim to overcome these limitations by extending recruitment periods, and enhancing participant engagement in control conditions. Further research could investigate the impact of consistency in intervention fidelity across sites. By addressing these issues, subsequent research can provide a more robust evaluation of community singing interventions and their potential to affect the quality of life for people with dementia and their carers. Declarations This research was funded by the National Institute of Health Research. Ethics approval was granted via IRAS (Project ID: 313298). All participants provided written informed consent for participation and the use of their anonymised data for research and publication. All consent forms and data from this study have been kept confidential and in keeping with the University of Nottingham guidelines and the Standard Operating Procedures provided by Nottinghamshire NHS Healthcare Trust. All data analysed and interpreted from this study are included in the published article and its supplementary files. The authors declare no competing interests. Author Contributions JS was the Chief Investigator of the PRESIDE project. BD, MO, PB, and OM were co-applicants, contributing to the project's design. LH designed the database and wrote the randomisation programme. LW, the project statistician, handled analysis with support from PB and team. LEO and BD, as Research Fellows, managed operational duties, including site setups. LEO, BD, JS, MO, and OM reviewed and interpreted the results. LEO was the lead writer, and all authors reviewed and amended the paper. Acknowledgements We would like to acknowledge the hard work and dedication shown by all the musicians that led the sessions at the three sites. References Anthony JC, LeResche L, Niaz U, von Korff MR, Folstein MF. Limits of the 'Mini-Mental State' as a screening test for dementia and delirium among hospital patients. Psychol Med. 1982;12(2):397–408. https://doi.org/10.1017/s0033291700046730 . 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Int Rev Psychiatry. 2020;32(5–6):477–90. https://doi.org/10.1080/09540261.2020.1765748 . Coulton S, Clift S, Skingley A, Rodriguez J. Effectiveness and cost-effectiveness of community singing on mental health-related quality of life of older people: Randomised controlled trial. Br J Psychiatry. 2015;207:250–5. https://doi.org/10.1192/bjp.bp.113.129908 . Docherty S, Haskell-Ramsay CF, McInnes L, Wetherell MA. The effects of COVID-19 lockdown on health and psychosocial functioning in older adults aged 70 and over. Gerontol Geriatric Med. 2021;7:23337214211039974. https://doi.org/10.1177/23337214211039974 . Dorris J, Rodakowski J. Music interventions for adults living with dementia. Am J Geriatric Psychiatry. 2024;32(3):312–4. https://doi.org/10.1016/j.jagp.2023.10.011 . Dowson B, McDermott O, Schneider J. What indicators have been used to evaluate the impact of music on the health and wellbeing of people with dementia? A review using meta-narrative methods. Maturitas. 2019;127:26–34. https://doi.org/10.1016/j.maturitas.2019.06.001 . Dowson B, Schneider J, Guo B, Bath PM, McDermott O, Haywood LJ, Orrell M. Pilot randomised evaluation of singing in dementia (PRESIDE): Protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control. Pilot Feasibility Stud. 2021;7(1):15. https://doi.org/10.1186/s40814-020-00759-y . Dowson B, Schneider J, McDermott O, Orrell M. Online singing groups for people with dementia: Adaptation and resilience in the face of the COVID-19 pandemic. Dement (London). 2023;22(7):1348–71. https://doi.org/10.1177/14713012231179262 . Freedman A, Nicolle J. Social isolation and loneliness: The new geriatric giants: Approach for primary care. Can Fam Physician. 2020;66(3):176–82. https://www.ncbi.nlm.nih.gov/pubmed/32165464 . Gold C, Eickholt J, Assmus J, Stige B, Wake JD, Baker FA, Tamplin J, Clark I, Lee YC, Jacobsen SL, Ridder HMO, Kreutz G, Muthesius D, Wosch T, Ceccato E, Raglio A, Ruggeri M, Vink A, Zuidema S, Geretsegger M. Music interventions for dementia and depression in elderly care (MIDDEL): Protocol and statistical analysis plan for a multinational cluster-randomised trial. BMJ Open. 2019;9(3):e023436. https://doi.org/10.1136/bmjopen-2018-023436 . Harding AJE, Morbey H, Ahmed F, Opdebeeck C, Elvish R, Leroi I, Williamson PR, Keady J, Reilly ST. A core outcome set for nonpharmacological community-based interventions for people living with dementia at home: A systematic review of outcome measurement instruments. Gerontologist. 2021;61(8):e435–48. https://doi.org/10.1093/geront/gnaa071 . Join Dementia Research. (n.d.). Register your interest in dementia research. National Institute for Health and Care Research. https://www.joindementiaresearch.nihr.ac.uk/ Osman SE, Tischler V, Schneider J. Singing for the Brain': A qualitative study exploring the health and well-being benefits of singing for people with dementia and their carers. Dement (London). 2016;15(6):1326–39. https://doi.org/10.1177/1471301214556291 . Smith SC, Lamping DL, Banerjee S, Harwood RH, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Development of a new measure of health-related quality of life for people with dementia: DEMQOL. Psychol Med. 2007;37(5):737–46. https://doi.org/10.1017/S0033291706009469 . Stoner CR, Orrell M, Spector A. Psychometric properties and factor analysis of the Engagement and Independence in Dementia Questionnaire (EID-Q). Dement Geriatr Cogn Disord. 2018;46(3–4):119–27. https://doi.org/10.1159/000488484 . Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): Development and UK validation. Health Qual Life Outcomes. 2007;5:63. https://doi.org/10.1186/1477-7525-5-63 . Veal BM, Dobbs D, Lee S, Bugos JA, Pyfrom MP, Boddupalli S, Lengacher CA, Meng H. Feasibility and acceptability of a group music intervention in memory care communities. J Appl Gerontol. 2022;41(6):1528–38. https://doi.org/10.1177/07334648221079118 . Whitlatch CJ, Orsulic-Jeras S. Meeting the informational, educational, and psychosocial support needs of persons living with dementia and their family caregivers. Gerontologist. 2018;58(suppl1):S58–73. https://doi.org/10.1093/geront/gnx162 . Wittenberg R, Knapp M, Hu B, Comas-Herrera A, King D, Rehill A, Shi C, Banerjee S, Patel A, Jagger C, Kingston A. The costs of dementia in England. *International Journal of Geriatric Psychiatry; 2019. Supplementary Files PRESIDECONSORT2010Checklist1.doc Cite Share Download PDF Status: Under Revision Version 1 posted Editorial decision: Minor revision 24 Apr, 2026 Reviewers invited by journal 22 Sep, 2025 Editor assigned by journal 27 Nov, 2024 First submitted to journal 26 Nov, 2024 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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\u003cli\u003e\u003cstrong\u003eWhat uncertainties existed regarding the feasibility?\u0026nbsp;\u003c/strong\u003eThe study highlighted challenges with recruitment, site fidelity, control group engagement, and uncertainties around long-term sustainability, all of which could impact the reliability and scalability of the intervention.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eWhat are the key feasibility findings?\u0026nbsp;\u003c/strong\u003eThe study demonstrated the feasibility of implementing the intervention, with high engagement, practical outcome measures, potential benefits to quality of life, and evidence of sustainability through independent continuation of activities.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eWhat are the implications of the feasibility findings for the design of the main study?\u0026nbsp;\u003c/strong\u003eThe findings highlight the need for enhanced recruitment strategies, standardized intervention fidelity measures, practical outcome assessments with larger samples and extended follow-up, and an embedded sustainability plan to support long-term implementation across varied settings.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Background","content":"\u003cp\u003eCommunity-based interventions are vital for improving the social, emotional, and practical aspects of life for people with dementia and their carers, helping them navigate the challenges of the condition more effectively (Baker et al., \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Harding et al., \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e2021\u003c/span\u003e; Veal et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Whitlatch and Orsulic-Jeras, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e2018\u003c/span\u003e). Community-based music interventions provide opportunities for social interaction, reducing feelings of loneliness and fostering a sense of belonging, (Coulton et al., \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e2015\u003c/span\u003e; Freedman and Nicolle, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e2020\u003c/span\u003e) including singing groups online (Dowson et al., \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e2023\u003c/span\u003e). Further, engaging in meaningful activities is thought to support cognitive function and emotional health (Baker et al., \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2023\u003c/span\u003e) while addressing agitation (Veal et al., 2023). Moreover community-based music interventions help integrate people with dementia into societal activities, challenging stigma and promoting a more inclusive and dementia-friendly environment (Baker et al., \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Tamplin et al., 2023). Interventions involving people with dementia and their carers in community singing activities may empower them to remain active and engaged, fostering a sense of purpose and autonomy (Baker et al., \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Tamplin et al., 2023, Osman et al., \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e2016\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eExisting evidence comes from small studies and is inconsistent, with some reporting no changes in standardized measures of quality of life, mood, or neuropsychiatric symptoms of dementia, despite positive qualitative findings (Baker et al., \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Dorris \u0026amp; Rodakowksi, 2024; Dowson et al., \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). Reliable evidence of benefit could inform social care strategy, attract additional funding for group singing initiatives, broaden options for social prescribers, and potentially alleviate pressure on health and social care services by enhancing the resilience of those with dementia and their caregivers in the community. Consequently, there is a need for rigorous, randomized controlled trial evidence to measure the effects of group singing on individuals with dementia and their caregivers.\u003c/p\u003e \u003cp\u003eThis feasibility study seeks to evaluate the practicality of implementing community singing groups and explore their potential impact on the quality of life and the emotional, cognitive, and social well-being of both people with dementia and their carers.\u003c/p\u003e\n\u003ch3\u003eAim\u003c/h3\u003e\n\u003cp\u003eThe purpose of the Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE) study was to test the feasibility of conducting a pragmatic, randomized trial of community singing in dementia with a waiting list control group. The key feasibility indicators were recruitment, retention after three months, and the acceptability of the waiting-list control trial design to participants. The secondary objective of the study was to examine the impact of group singing on people with dementia and their carers, using a range of standardised patient reported outcome measures, including quality of life and well-being.\u003c/p\u003e "},{"header":"Methods \u0026 Design","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003cp\u003eThe study was a two-arm, randomised controlled, feasibility trial of community group singing using a waiting list control. Each dyad, consisting of a main participant (person with dementia) and a secondary participant (carer) was randomised into a control arm or intervention arm. The control arm waited up to 12-weeks before beginning singing sessions whereas the intervention arm joined the singing session immediately post-baseline measures, for a minimum 10-week period. The study was carried out in three sites in the East Midlands of England. For anonymity, they are referred to as sites A, B, and C.\u003c/p\u003e \u003cp\u003eIn keeping with the study design, a range of patient reported outcome measures (PROM) were used that reflected the wellbeing of the person with dementia and the care partner, as well as the relationship of this dyad. This battery was informed by the results of a study of online singing during the COVID pandemic (Dowson \u0026amp; Schneider, 2023). We also included measures of cognition to monitor disease progression, although we did not hypothesise that singing would be a disease-modifying intervention; rather, we predicted that its main effect would be on quality-of-life measures.\u003c/p\u003e \u003cp\u003ePROMs were measured at baseline (T0), three months post-baseline (T1) and six months post-baseline (T2) and completed within the home of the person with dementia. Control arm participants were offered singing intervention sessions at T1. Hence, all participants, regardless of randomised arm, had access to singing between months 3 and 6 of the study. Demographic data (age, sex, ethnicity, education, musical/singing experience) were collected at T0.\u003c/p\u003e \u003cp\u003ePROMs used included instruments to assess of quality of life (DEMQOL/DEMQOL Proxy; Smith et al., \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e2007\u003c/span\u003e), social independence (Engagement and Independence in Dementia Questionnaire; Stoner et al., 2017), dementia specific outcomes (Dementia Core Outcome Set; Reilley et al., 2020), loneliness (Three-item Loneliness Scale; Hughes et al., 2003), musical engagement (Musical Engagement Questionnaire 15-item version; Vanstone et al., 2016), wellbeing (Short Warwick-Edinburgh Mental Wellbeing Scale; Tennant et al., \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e2007\u003c/span\u003e), depression (Geriatric Depression Scale; Yesavage et al., 1982), and cognition (Mini Mental State Examination; Folstein et al., 1975).\u003c/p\u003e \u003cp\u003eAt baseline, PROMs were collated per dyad. They took approximately two hours to complete. Post baseline, two researchers and delivery staff who were \u0026lsquo;blind\u0026rsquo; to condition were assigned to administer the PROMs. This worked well and reduced the time taken to complete all PROMs.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eParticipants who lacked capacity to provide informed consent at recruitment were excluded to ensure ethical integrity. Consent was treated as an ongoing process, with continuous monitoring of participants' capacity. When a participant\u0026rsquo;s capacity deteriorated, a consultee was appointed to provide guidance on their continued involvement. If the participant or consultee expressed a wish to withdraw, participation was promptly terminated, retaining the data collected to date, ensuring the study remained ethically sound and voluntary.\u003c/p\u003e \u003cp\u003eOther exclusion criteria included significant hearing impairments ; simultaneous participation in other interventional studies; and history of severe mental illness, alcohol or drug addiction.\u003c/p\u003e \u003cp\u003eAt the start of the project, which impacted the first site only, participants with dementia who had been in other singing groups in the past 6 weeks were excluded from the study. However, due to slow recruitment and given that the study\u0026rsquo;s purpose was to test feasibility criteria rather than outcomes for participants, a substantial amendment was made in February 2023 to include participants who had engaged with singing within the past 6 weeks.\u003c/p\u003e \u003cp\u003eThe inclusion criteria for people with dementia were: a formal diagnosis of mild to moderate dementia; being at least 18 years old; and having a carer who spent more than two hours per week with them. To be included, participants also had to be willing to join a singing group and attend weekly; be able to give informed consent; and be able to speak English. Similarly, carers were required to speak and understand English; to be willing to give informed consent; and to be willing, in principle, to attend the singing group regularly for at least 10 weeks.\u003c/p\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003ePreliminary online singing sessions following a similar intervention protocol were conducted during the COVID pandemic, delivering 30 sessions. Through this experience, the research team gained insights into the effective balance of warm-up exercises, conversation, and singing and refined the intervention protocol for PRESIDE (Dowson et al,, 2021). For the present (face to face) study, three experienced community singing group leaders were recruited to run the sessions. They were provided with a guidance manual (see supplementary material) that describes the essential and optional elements of the intervention, while leaving them free to use their skills and experience (cf. Gold et al., \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). A song book was produced to support the sessions, but it was not compulsory.\u003c/p\u003e \u003cp\u003eSinging sessions ran for 120 minutes (approximately 30 minutes of gentle exercise and vocal warm-ups, 60 minutes singing familiar and new songs or talking about music, and intermittent breaks accumulating to another 30 minutes). Fidelity scales for the intervention (see supplementary material) were administered at the start and again at 8 and 16 weeks. Participants randomised to start singing sessions right away were asked to attend weekly for 10 weeks. After this time, they could continue with the group if they wished, and the participants in the control arm joined the sessions.\u003c/p\u003e\n\u003ch3\u003eSample Size\u003c/h3\u003e\n\u003cp\u003eThe target sample size was 160 participants or 80 dyads, forty in each arm. It was calculated that a full trial with quality of life as its main PROM would need to recruit 360 analysable pairs and yield 80% power of achieving statistical significance at 5% level with 2-sided test if effect size ∆ = 0.3 (small). The 2-arm equal-allocation feasibility trial aims to justify full trial but achieve significance only if ∆ exceeds 0.65 (large).\u003c/p\u003e\n\u003ch3\u003eRandomisation and ‘blinding’\u003c/h3\u003e\n\u003cp\u003eParticipants were stratified based on age with minimisation by age (+/- 80), sex and experience of singing, and computerised randomisation was performed in each stratum, so that it is weighted to account for these critical factors. This process was competed by LH.\u003c/p\u003e \u003cp\u003eThe trial statistician (LW) and research staff administering 3 months (T1) and 6 months (T2) PROMs remained unaware of study arm allocation until analysis was complete. Research staff managing the project (BD, LO) were aware of study arm allocation because they attended singing sessions and conducted qualitative interviews.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eRecruitment\u003c/h2\u003e \u003cp\u003eThe study was open to recruitment from October 2022 to June 2023. Each site had approximately three months to recruit prior to the first singing session starting. In total 30 weeks of the singing was provided to maximise on the window of opportunity available to recruit participants who could complete their 10-week intervention within this period.\u003c/p\u003e \u003cp\u003ePotential participants were screened over the telephone and pre-assessment home visits were arranged. Extensive recruitment efforts included advertising with social prescribers, engagement with Local Authorities and District Councils, distribution in day centres, visits to local GP surgeries, dementia cafes, post offices, pharmacies, libraries, and local television appearances. The \u0026lsquo;Join Dementia Research\u0026rsquo; database was accessed to identify suitable participants in each local region (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.joindementiaresearch.nihr.ac.uk\u003c/span\u003e\u003cspan address=\"http://www.joindementiaresearch.nihr.ac.uk\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eThe aim of the statistical analysis was to assess: the heterogeneity of the sample, retention rates in each arm of the study, and the performance of the PROMs in terms of their acceptability and validity, judged by missing data, as well as their apparent sensitivity to change, judged by variability and change over time. The statistician (LW) therefore generated descriptive data, summarizing demographic and PROM, with mean and standard deviation (SD) for normally distributed variables; median and interquartile ranges (IQR) for skewed variables; frequency and percentages (%) for categorical variables. These data were analysed by study arm at baseline, T1 (3 months) and T2 (6 months). Confidence intervals were reported to convey precision of estimates as the feasibility was not powered to detect effects.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eDemographic Characteristics\u003c/h2\u003e \u003cp\u003eThe intervention and control arms were similar in age and ethnicity, with balanced demographic representation across both study arms on most variables (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The majority of the participants were White British.\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\u003eSample Characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c2\" namest=\"c1\" rowspan=\"2\"\u003e \u003cp\u003eBaseline Randomisation Characteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eBaseline: Person with Dementia\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eBaseline: Carer\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eINT\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eINT\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e77.3 (7.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e75.9 (8.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e67.5 (11.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e68.8 (9.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (27.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (44.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e26 (72.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e12 (66.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEthnicity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWhite\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18 (100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18 (100)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17 (94.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18 (100)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRelationship\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSpouse/partner\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" morerows=\"2\" nameend=\"c4\" namest=\"c3\" rowspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15 (83.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13 (72.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eChild\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (11.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4 (22.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFriend / other\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (5.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (5.6)\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=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eINSERT Table \u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/h2\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003eRecruitment\u003c/h2\u003e \u003cp\u003eThe target of 160 participants (80 dyads) was not achieved. Despite strenuous recruitment efforts over more than eight months, only 45% of the target sample was achieved: 72 participants (36 dyads ) consented across three sites, A (n\u0026thinsp;=\u0026thinsp;28; 14 dyads), B (n\u0026thinsp;=\u0026thinsp;22; 11 dyads), and C (n\u0026thinsp;=\u0026thinsp;22; 11 dyads) (see Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eINSERT FIGURE \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/h2\u003e \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e \u003ch2\u003ePrior Singing Experience\u003c/h2\u003e \u003cp\u003eMost participants (77.8%) indicated that had \u0026lsquo;none\u0026rsquo; or \u0026lsquo;not much\u0026rsquo; prior singing experience (14 participants in both INT and Control arms). 22.3% indicated that they had \u0026lsquo;quite a lot\u0026rsquo; or \u0026lsquo;extensive\u0026rsquo; singing experience (4 participants in both INT and Control arms). Prior musical engagement was further measured via the Musical Engagement Questionnaire, for both the intervention and control arms. This showed MusEQ mean score (\u0026plusmn;\u0026thinsp;SD) of 35.4 (6.7) in the intervention arm and 34.9 (7.2) in the control arm indicated a relatively low engagement with music prior to the study commencing.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eRetention\u003c/h2\u003e \u003cp\u003eThe retention rate at T1 (primary end point) was 78% in both arms. At T2, participant retention was lower in the intervention group (66.7%) than in the control group (77.8%). As shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, the number of participants who withdrew were 22.2% in both the intervention and control arms.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eAttendance\u003c/h2\u003e \u003cp\u003eAcross all sites, 77.8% participants attended 5 or more sessions (50%) in the intervention group compared with 55% participants in the control arm. This includes 33% of participants in the control arm (waiting list) that attended no community singing sessions, compared to 6% of the intervention arm.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eSinging Session Fidelity\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows Fidelity Checklist Adherence across three sites (A, B, and C). Higher percentages indicate fidelity to the intended model. Site A showed the highest adherence (86.3%) and Site B showed the lowest (65.61%). Overall, a high adherence to fidelity rate was achieved, observing a mean 78.8% across all sites (see Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\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\u003eFidelity Checklist Adherence by Site\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e \u003cp\u003e% Fidelity Checklist Adherence\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\u003eFacilitator\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSite A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSite B\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eSite C\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eItem Mean %\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"8\" rowspan=\"9\"\u003e \u003cp\u003eEssential Session Components\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eWelcome and check in\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePhysical warm up\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e83.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e94.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVocal warm Up\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e87.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e62.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOpening song\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e62.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e58.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSinging familiar songs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSong choices offered\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e68.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eClosing song\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e41.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e46.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRefreshments\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotals\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e86.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e65.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e84.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e78.75\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\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThree Month Outcome Measures for People with Dementia and Carers\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\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003e3 Month Outcome Measures for People with Dementia\u003c/p\u003e \u003cp\u003e(T0-T1)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c8\" namest=\"c5\"\u003e \u003cp\u003e3 Month Outcome Measures for Carers\u003c/p\u003e \u003cp\u003e(T0-T1)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eINT (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eControl (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c5\" namest=\"c4\" rowspan=\"2\"\u003e \u003cp\u003eaMD (95% CI)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eINT (n-13)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eControl (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eaMD (95% CI)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eMean (+/- SEM)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eMean (+/- SEM)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDEMQOL\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e100.2 (10.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e94.9 (13.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e0.38 (-6.91, 7.67)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDEMQOL-PROXY\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e97.1 (14.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e91.1 (10.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e2.29 (-6.42, 11.00)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEID-Q: ...Activities of Daily Living\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18.3 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17.3 (4.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e1.11 (-1.12, 3.35)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e...Decision Making\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13.1 (2.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11.7 (2.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e1.25 (-0.29, 2.79)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e...Activity Engagement\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.5 (1.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.9 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e1.22 (-0.30, 2.74)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e...Support\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24.8 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.5 (2.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e-0.12 (-2.58, 2.34)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026hellip;Reciprocity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19.2 (3.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.0 (4.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e1.03 (-2.02, 4.08)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDementia core outcome set\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e37.1 (2.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36.0 (3.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e0.81 (-1.25, 2.87)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMMSE-brief\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.7 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.1 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e-0.64 (-2.47, 1.18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThree-item loneliness scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.8 (1.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.1 (1.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e-0.12 (-1.04, 0.80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4.8 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.5 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.67 (-0.23, 1.56)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEQ-5D-5L HSUV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.86 (0.26)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.82 (0.16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e0.03 (-0.13, 0.19)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.81 (0.17)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.73 (0.23)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.05 (-0.08, 0.18)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEQ-VAS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e66.5 (15.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e66.8 (12.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e-1.07 (-11.4, 9.29)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e75.0 (19.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e75.9 (17.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e5.07 (-5.86, 16.00)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeriatric depression scale, GDS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.3 (1.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.3 (3.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e-0.42 (-2.47, 1.63)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4.3 (2.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3.1 (2.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.04 (-0.70, 2.78)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSWE Mental Wellbeing scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56.6 (7.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e53.2 (8.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e2.84 (-2.54, 8.22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e48.7 (8.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e52.4 (7.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e-1.87 (-6.97, 3.24)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSIDECAR \u0026hellip;(D) Direct impact\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" morerows=\"2\" nameend=\"c4\" namest=\"c2\" rowspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e9.5 (5.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e8.0 (3.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.26 (-2.04, 2.56)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026hellip;(I) Indirect impact\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e6.2 (2.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6.3 (2.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.58 (-0.85, 2.01)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026hellip;(S) Support and information\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003e5.8 (2.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e6.5 (2.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e-0.36 (-2.04, 1.32)\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=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eINSERT Table \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003c/h2\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003ch2\u003ePatient Report Outcome Measures (PROMs)\u003c/h2\u003e \u003cp\u003eThe intervention and control arms did not differ significantly on any PROM. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows the mean scores and standard deviations, 95% confidence intervals for the outcome measures at T1 (3 months) for people with dementia and carers, respectively.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eINSERT Table \u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u003c/h2\u003e \u003cp\u003eTreatment effects were assessed at T1 using adjusted Mean Differences (aMD) with 95% Confidence Intervals (CI) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The largest observed effect was for DEMQOL, with an aMD of 0.38 (positive effect). For the intervention group, scores increased from 95.7 to 100.2 between baseline and T1 (aMD = -4.43, 95% CI: -13.1 to 4.19). A similar slight increase was observed in the waiting list control group, with scores rising from 94.9 to 98.4 (aMD = -3.50, 95% CI: -12.3 to 5.3). This pattern was also reflected in the DEMQOL-Proxy scores (see Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eFor people with dementia, Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e suggests that group community singing sessions had a positive impact in the intervention group on decision-making abilities (aMD = -2.90, 95% CI: -5.31, -0.49), reciprocity in relationships (aMD = -3.41, 95% CI: -6.72, -0.09), and mental well-being (aMD = -6.76, 95% CI: -13.2, -0.29). Comparatively, no significant differences were observed in the waiting list control group for decision-making abilities, reciprocity, or mental well-being (95% CI not overlapping).\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\u003ePost Singing Session Comparisons Between intervention and Control Groups for People with Dementia\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eINT\u003c/p\u003e \u003cp\u003eBaseline v 3 Months (T0vT1)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e3 months v 6 Months (T1vT2)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBaseline (n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 months (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eaMD (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 months (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6 months (n\u0026thinsp;=\u0026thinsp;14)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eaMD (95% CI)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDEMQOL\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95.7 (14.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100.2 (10.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-4.43 (-13.1, 4.19)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e94.9 (13.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e98.4 (11.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-3.50 (-12.2, 5. 23)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDEMQOL-PROXY\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e91.8 (17.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e97.1 (14.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-5.29 (-17.9, 7.30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e91.1 (10.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e96.8 (14.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e5.75 (-16., 4.73)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEID-Q:\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e...Activities of Daily Living\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16.7 (5.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.3 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-1.6 (-4.44, 1.24)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17.3 (4.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e17.3 (3.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.05 (-2.68, 2.78)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e...Decision Making\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10.2 (4.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13.1 (2.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-2.90 (-5.31, 0.49)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11.7 (2.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11.2 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.50 (-1.67, 2.67)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e...Activity Engagement\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.3 (2.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.5 (1.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-1.17 (-2.73, 0.40)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8.9 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9.1 (2.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-0.21 (-1.74, 1.31)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e...Support\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22.9 (4.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24,8 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-1.89 (-4.67, 0.89)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e24.5 (2.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e24.7 (3.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-0.18 (-2.40, 2.05)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026hellip;Reciprocity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15.8 (5.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19.2 (3.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-3.41 (-6.72, -0.09)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e18.0 (4.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e19.1 (4.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-1.07 (-4.14, 1.99)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMMSE-brief\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.6 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.7 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-0.08 (-2.37, 2.21)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10.1 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e10.2 (3.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-0.07, (-2.66, 2.52)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThree-item loneliness scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.1 (1.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.8 (1.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.35 (-0.60, 1.30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4.1 (1.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3.9 (1.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.21 (-0.80, 1.23)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDementia core outcome set\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e34.7 (4.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37.1 (2.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-2.37 (-5.13, 0.39)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e36.0 (3.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e36.9 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-0.92 (-2.89, 1.05)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEQ-5D-5L HSUV\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.85 (0.19)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.86 (0.26)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-0.01 (-0.16, 0.14)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.82 (0.16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.83 (1.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-0.01 (-0.12, 0.10)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEQ-VAS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e75.8 (18.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e66.5 (15.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9,29 (-2,61, 21.20)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e66.8 (12.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e66.1 (19.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.64 (-11.1, 12.34)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeriatric depression scale, GDS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.5 (2.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.3 (1.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.14 (-0.54, 2.81)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3.3 (3.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2.9 (3.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.42 (-2.17, 3.01)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSWE mental wellbeing scale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e49.8 (9.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e56.6 (7.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-6.76 (-13.2, -0.29)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e53.2 (8.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e53.7 (8.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-0.48 (-6.47, 5.51)\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=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eINSERT Table \u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003c/h2\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe data gathered indicate that it was feasible to collect these PROMs from both people with dementia and their carers. Both people with dementia and carers were able to complete the assessments and measures without major issues.\u003c/p\u003e \u003cp\u003eWhilst there was a lack of significant differences observed within and between groups, and no strong trends emerged, there were slight improvements in quality of life, well-being and daily activities for people with dementia in the intervention group. These findings suggest that the intervention could potentially have positive effects, but more participants and a longer follow-up period are needed to confirm such benefits.\u003c/p\u003e \u003cp\u003eThe demographic profiles of the intervention and control arms were well-matched, with age and ethnicity being balanced across both groups. Predominantly, participants were White British, reflecting a relatively homogeneous sample in terms of ethnic background. This similarity ensures that demographic factors are unlikely to have introduced bias into the study\u0026rsquo;s outcomes. Singing experience and the Musical Engagement Questionnaire, indicated that participants generally had relatively low levels of engagement with singing prior to starting the study.\u003c/p\u003e \u003cp\u003eThis feasibility study provides valuable insights into the impact of community singing interventions for people with dementia and their carers, but several limitations must be acknowledged. Firstly, the recruitment process presented challenges despite removing the exclusion criteria that prevented participants from joining with previous group singing experience. We found that using the Join Dementia Research database proved to be the most effective method of recruitment (Join Dementia Research, n.d. ). The slow rate of recruitment aligns with findings from other studies in this area (Baker et al., \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Veal et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2022\u003c/span\u003e). Other barriers to recruitment may include psychosocial, geographical, logistical, stigma-related and financial impediments. For example, recruitment took place following lockdown restrictions from the COVID-19 pandemic, which could have discouraged participants (Docherty et al., \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). Closer analysis of the pandemic\u0026rsquo;s impact on this study is undertaken in [paper in preparation]. .\u003c/p\u003e \u003cp\u003eRecruitment remains a serious issue as under-recruitment limits sample size, which limits the statistical power of the study. This could have resulted in a Type 2 error, failing to show any statistical significance. Therefore, future studies could benefit from extending the recruitment timeframe and increasing the number of singing sessions to enable the recruitment target to be reached.\u003c/p\u003e \u003cp\u003eThe waiting-list control design was broadly accepted, indeed the control-arm participants demonstrated staying power in completing more of their intervention sessions. However, drop-out was higher in the control arm, and these findings suggest that simply being on a waiting list without active participation may result in diminished motivation and interest among participants (Coulton et al., \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e2015\u003c/span\u003e; Veal et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2022\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eRetention in both arms was, overall, good, although higher retention rates were observed in the control group. When investigating further, outside factors, such as the complexities of living with dementia could be attributed to drop out rather than the impact of the intervention itself. The slight changes in retention rates between intervention and control arms do not adequately reflect the sustainability of the community singing intervention.\u003c/p\u003e \u003cp\u003eThe study achieved high fidelity rates overall, showing many strong components (such as \"Welcome and Check-in,\" \"Singing Familiar Songs,\" \"Refreshments\"). Sites differed somewhat in \u0026ldquo;Song Choices Offered\u0026rdquo; and using an \"Opening Song\u0026rdquo; or a \"Closing Song\u0026rdquo;. It remains unclear if such differences between sites are likely to influence the intended PROMs but this is a question which future studies could address. Post intervention, self-sustainability was observed across all sites in various ways. Our study showed one site transitioned to an independent singing group for people with dementia and their carers, managed by a charitable organisation, retaining its membership base who took responsibility for the breaktime drinks and snacks. Another site secured external funding with a national charity to continue singing activities for individuals with dementia and their carers. Our final site did not continue as a group, but all participants joined other local singing groups with the exception of two dyads; one dyad has started their own singing group in a care home whilst the other dyad is seeking something a little more local to them. This enduring engagement suggests that the participants found significant value and enjoyment in the sessions, which contributed to their continued participation beyond the study\u0026rsquo;s formal end. In addition to the potential cost-effectiveness, the self-sustainability of these groups indicates that a high level of acceptability and perceived benefit among the participants, indicating that community singing interventions foster lasting community engagement and personal satisfaction. This study supports community singing as a potentially effective and efficient intervention to improve the quality of life for people with dementia and their carers, and our results should be taken into account in future trials.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis feasibility study has provided meaningful insights into the potential benefits and challenges associated with community singing interventions for people with dementia and their carers. The findings indicate that, while the intervention may offer positive effects on quality of life, well-being, and daily activities, the small sample size and various limitations remain to be addressed in future research.\u003c/p\u003e \u003cp\u003eThe PRESIDE study has demonstrated the feasibility of the measures used and the acceptability of the intervention, with high retention rates. It also showed high fidelity to key intervention components. The observed self-sustainability of the singing groups post-intervention further supports the intervention's potential for long-term impact and community engagement. However, the challenges of recruitment and control condition design, highlight areas for improvement.\u003c/p\u003e \u003cp\u003eFuture studies should aim to overcome these limitations by extending recruitment periods, and enhancing participant engagement in control conditions. Further research could investigate the impact of consistency in intervention fidelity across sites. By addressing these issues, subsequent research can provide a more robust evaluation of community singing interventions and their potential to affect the quality of life for people with dementia and their carers.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eThis research was funded by the National Institute of Health Research. Ethics approval was granted via IRAS (Project ID: 313298). All participants provided written informed consent for participation and the use of their anonymised data for research and publication. All consent forms and data from this study have been kept confidential and in keeping with the University of Nottingham guidelines and the Standard Operating Procedures provided by Nottinghamshire NHS Healthcare Trust. All data analysed and interpreted from this study are included in the published article and its supplementary files. The authors declare no competing interests.\u003c/p\u003e\u003ch2\u003eAuthor Contributions\u003c/h2\u003e \u003cp\u003eJS was the Chief Investigator of the PRESIDE project. BD, MO, PB, and OM were co-applicants, contributing to the project's design. LH designed the database and wrote the randomisation programme. LW, the project statistician, handled analysis with support from PB and team. LEO and BD, as Research Fellows, managed operational duties, including site setups. LEO, BD, JS, MO, and OM reviewed and interpreted the results. LEO was the lead writer, and all authors reviewed and amended the paper.\u003c/p\u003e\u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003eWe would like to acknowledge the hard work and dedication shown by all the musicians that led the sessions at the three sites.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAnthony JC, LeResche L, Niaz U, von Korff MR, Folstein MF. 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The costs of dementia in England. *International Journal of Geriatric Psychiatry; 2019.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"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":"Community singing, dementia, feasibility study, intervention, quality of life, participant engagement","lastPublishedDoi":"10.21203/rs.3.rs-5198553/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5198553/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003e Community singing interventions have been explored as potential therapeutic activities for people with dementia and their carers. This feasibility study aimed to evaluate the practicality, engagement, and preliminary outcomes of such an intervention.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA total of 72 participants (36 dyads) were recruited across three sites, achieving 45% of the target sample size. Participants were randomly assigned to an intervention group, which engaged in community singing sessions, or a waiting list control group. Demographic characteristics were balanced between groups, and baseline musical engagement was low. Recruitment challenges and varying site fidelity were noted.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe intervention demonstrated high feasibility, with patient reported outcome measures being practical and successfully administered. Despite a lack of statistically significant differences in patient reported outcome measures due to the small sample size, slight improvements were observed in quality of life, well-being, and daily activities within the intervention group. Retention rates were good, although slightly higher in the control group. Notably, post-intervention, all sites transitioned to independent community singing groups or secured funding for continued activities, indicating strong participant engagement and perceived value.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe study highlights the potential benefits of community singing interventions for people with dementia and their carers, suggesting improvements in quality of life and well-being. However, challenges such as recruitment and control condition engagement must be addressed in future research. Larger sample sizes and extended follow-up periods are necessary to confirm the intervention\u0026rsquo;s effectiveness and to explore its long-term impact.\u003c/p\u003e\u003ch2\u003eTrial Registration:\u003c/h2\u003e \u003cp\u003e Funded by NIHR Research for Patient Benefit \u0026ndash; Social Care (NIHR202982) and has been registered with ISRCTN (10201482) and IRAS (Project ID: 313298). The University of Nottingham is the trial sponsor.\u003c/p\u003e","manuscriptTitle":"Evaluating The Feasibility of Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE) in Community Group Settings","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-03 16:32:19","doi":"10.21203/rs.3.rs-5198553/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2026-04-24T22:22:45+00:00","index":"","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-22T10:34:53+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-11-27T07:57:58+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2024-11-26T10:25:14+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":"f959af22-0bd2-49c6-a5a1-bd460e413fa5","owner":[],"postedDate":"October 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"in-revision","subjectAreas":[],"tags":[],"updatedAt":"2026-04-25T02:24:19+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-03 16:32:19","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5198553","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5198553","identity":"rs-5198553","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}