Digital Self-Management Application for Patients Undergoing Hemodialysis: Effects on Health Awareness and Frailty

Digital Self-Management Application for Patients Undergoing Hemodialysis: Effects on Health Awareness and Frailty | 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 Digital Self-Management Application for Patients Undergoing Hemodialysis: Effects on Health Awareness and Frailty Chieko HAMADA, Mitsumine FUKUI, Yasuhiko TOMINO, Reo KANDA, Atsuko URITA This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9355105/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 12 You are reading this latest preprint version Abstract Background Digital health interventions are increasingly used to support self-management in patients with chronic diseases; however, their impact on patient-centered outcomes, including health awareness and frailty, in maintenance hemodialysis populations remains insufficiently understood. This study aimed to evaluate the multidimensional effects of a digital self-management application on clinical and patient-reported outcomes. Methods This prospective observational study included 12 patients undergoing maintenance hemodialysis. A digital self-management application was introduced for 3 months to support daily health monitoring. The application combined automatic data collection (physical activity) and patient-reported inputs (vital signs, weekly health status, and behavioral tracking). Clinical parameters, health consciousness, eHealth literacy–related behaviors, and frailty assessed by the Kihon Checklist were evaluated at baseline and after the intervention. Results The mean age of participants was 65.4 ± 6.4 years, and the mean dialysis duration was 5.9 ± 8.1 years. Hemoglobin levels significantly increased from 10.8 ± 1.0 g/dL to 11.8 ± 1.0 g/dL (p = 0.02), while other clinical parameters showed no significant changes. The total Health Consciousness Scale score significantly decreased from 36.5 ± 7.7 to 31.8 ± 7.8 (p < 0.05), indicating changes in health-related perceptions and attitudes. Frailty scores showed a reduction from 6.8 ± 4.2 to 5.4 ± 1.3, suggesting a trend toward improvement (p = 0.06), with the greatest improvement observed in depressive symptoms. Conclusions A digital self-management application may influence both clinical indicators and patient-centered outcomes, particularly health awareness and psychological aspects of frailty, in patients undergoing maintenance hemodialysis. These findings suggest that digital interventions may enhance patient engagement and support a shift toward patient-centered dialysis care, warranting further investigation in larger studies. Dialysis patients Self-management Digital health intervention eHealth literacy Patient engagement Figures Figure 1 Introduction Patients undergoing maintenance hemodialysis are required to adhere to complex treatment regimens, including strict control of fluid intake, dietary potassium and phosphorus restriction, medication adherence, and management of multiple comorbidities such as cardiovascular disease and diabetes. These demands place a substantial burden on patients and make effective self-management a central component of dialysis care. Poor self-management has been associated with increased hospitalization, complications, and reduced quality of life among dialysis patients ( 1 , 2 ). Traditionally, dialysis care has focused primarily on clinical outcomes such as survival and biochemical control. However, recent shifts toward patient-centered care emphasize broader outcomes including well-being, quality of life, and patient engagement in health management. In this context, patients are increasingly expected to actively participate in managing their health and daily life rather than passively following medical instructions ( 3 ). Health literacy plays a critical role in enabling patients with chronic diseases to engage in effective self-management. Health literacy encompasses the ability to obtain, understand, evaluate, and apply health information to make appropriate health decisions. Previous studies have shown that inadequate health literacy is common among patients with chronic kidney disease and dialysis and is associated with poorer health outcomes, reduced treatment adherence, and increased mortality ( 4 , 5 ). With the rapid expansion of digital health technologies, electronic health literacy (eHealth literacy) has emerged as an important extension of health literacy. eHealth literacy refers to the ability to seek, evaluate, and apply health information obtained through digital platforms such as the internet, mobile applications, and online health services. Digital health interventions—including mobile health applications, remote monitoring systems, and telehealth programs—have increasingly been introduced to support self-management in chronic diseases ( 4 , 5 ). In nephrology, digital health interventions have shown promising potential for improving patient engagement, treatment adherence, and quality of life in individuals with chronic kidney disease and dialysis therapy. Several studies have reported that mobile health applications and digital monitoring systems can enhance patient participation in health management and support behavioral changes necessary for effective self-management ( 6 , 7 ). However, engagement with digital health technologies varies widely among patients. Emerging evidence suggests that proactive health awareness, defined as an individual’s active interest in maintaining and improving their health, may be a key determinant of digital health utilization and eHealth literacy. Individuals with higher health awareness are more likely to actively seek health information, critically evaluate digital resources, and apply acquired knowledge to their daily health behaviors ( 8 , 9 ). Despite increasing attention to digital health interventions in nephrology, the relationships between health awareness, eHealth literacy, and health-related outcomes in maintenance dialysis patients remain insufficiently understood ( 9 ). In particular, little is known about how these factors relate to frailty status and the acceptability of digital self-management tools among dialysis populations, who are often older and medically complex (10.11). Therefore, the present study aimed to investigate the relationship between health awareness and eHealth literacy in patients undergoing maintenance hemodialysis, and to examine their associations with frailty status. In addition, this study explored the acceptability of a digital self-management application and evaluated whether digital health interventions may facilitate behavioral changes in health management and contribute to improving eHealth literacy. By clarifying these relationships, this study may provide evidence supporting the development of digital health strategies that promote patient-centered self-management and contribute to a paradigm shift in dialysis care. Methods Study Design and Participants (Figure 1) This study was designed as a cross-sectional observational study conducted at an outpatient dialysis center. Patients aged ≥20 years who had been receiving maintenance hemodialysis three times per week for at least 3 months were eligible for participation. Patients were recruited from outpatient dialysis units during the study period. Individuals who were unable to provide informed consent, had severe cognitive impairment, or had acute medical conditions that could affect participation were excluded. All participants provided written informed consent prior to enrollment. A health self-management application was used to support participants’ daily health monitoring. The application automatically collected physical activity data, including step counts and the number of flights of stairs climbed, using smartphone sensors. Participants also entered health parameters such as blood pressure and body weight. In addition, weekly health status-including physical condition, sleep quality, dietary intake, and mental well-being-was recorded using a standardized scale. Optional behavioral stamps allowed users to record health-related activities. All collected data were visualized within the application interface on a daily or weekly basis, enabling users to monitor their health status and observe trends over time, thereby supporting self-management behaviors. Ethical Considerations This study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the institutional ethics committee of the participating each institution (IRB approval number for Juntendo University Faculty of Health Sciences and Nursing: 6-005, IRB approval numbers for Medical Corporation SHOWAKAI: 2024S-13 and 2024S-15). Written informed consent was obtained from all participants prior to participation. Data Collection Data were collected from medical records, physical assessments, and self-administered questionnaires. Clinical information was obtained from patients’ medical records and included blood biochemical parameters, interdialytic weight gain (IDWG) at the beginning of the week, blood pressure fluctuations during dialysis at the beginning of the week, and the number and types of prescribed medications. These indicators were used to evaluate clinical status and dialysis-related management. Physical Assessment Physical function was assessed using grip strength, which is widely used as an indicator of muscle strength and frailty in patients with chronic diseases. Grip strength was measured using a hand dynamometer according to standardized measurement procedures. Questionnaire Assessments Participants completed self-administered questionnaires assessing health awareness （Table 1）, digital health literacy, and frailty. Health awareness was assessed using the Japanese version of the Health Interest Scale developed by Ozawa et al., which is based on elements of health awareness scales (12,13) and health motivation scales (12), which are similar concepts to health interest (14). Digital health literacy was assessed using eHealth Literacy Scale (eHEALS) (Table 2), which evaluates individuals perceived ability to seek, understand, evaluate, and apply health information obtained from electronic sources (15). Frailty status was assessed using the Kihon Checklist (Table 3a and 3b), a self-reported screening questionnaire developed by the Japanese Ministry of Health, Labor and Welfare that evaluates multiple domains, including physical function, nutritional status, social activity, and cognitive function (16). Ethical Considerations This study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board (IRB) Research Ethics Committee of the Faculty of Health Science and Nursing at Juntendo University (IRB approval number 6-005) and the Toyu Medical Research Ethics Review Committee of the Medical Corporation Showakaii (IRB approval number 2024S-13, 2024S-15). Written informed consent was obtained from all participants prior to participation. Statistical Analysis Continuous variables are presented as mean ± standard deviation or median (interquartile range), depending on data distribution. Categorical variables are presented as frequencies and percentages. Group comparisons were performed using the Student’s t-test or Mann–Whitney U test for continuous variables and the chi-square test for categorical variables. Correlation analyses were conducted to examine the relationships between health consciousness, eHealth literacy, and frailty-related variables. Multiple regression analysis was performed to identify factors independently associated with eHealth literacy and health management behaviors. All statistical analyses were performed using statistical software, and a two-sided P value <0.05 was considered statistically significant. This study was reported in accordance with the STROBE guidelines. Results Participants (Table 4) The study included 12 patients undergoing maintenance hemodialysis (9 men and 3 women). The mean age was 65.4 ± 6.4 years, and the mean dialysis duration was 5.9 ± 8.1 years. The primary cause of dialysis initiation was diabetic nephropathy in six patients. Regarding medical history, one patient had a history of stroke, two had ischemic heart disease, two had malignant tumors, and one had a history of fracture. The mean number of prescribed medications at baseline was 9.3 ± 3.7 types. In terms of social background, one patient lived alone, three lived with a spouse only, and eight lived with family members. Regarding educational attainment, three patients had graduated from university and nine had graduated from high school. With respect to employment status, one patient was a full-time employee, three were self-employed, one was a non-regular employee, and seven were pensioners. Annual income was less than 4 million yen in six patients and 4 million yen or more in six patients. Clinical Outcomes Changes in clinical parameters before and after the intervention are summarized in Table 5 . The mean number of prescribed medications slightly decreased from 9.3 ± 3.7 at baseline to 8.5 ± 3.4 in 3 months, although the difference was not statistically significant ( p = 0.21). During the study period, hospitalization occurred in four patients; however, these hospitalizations were related to treatment for previously diagnosed malignancy (n = 1) and arteriovenous fistula dysfunction (n = 3). Interdialytic weight gain at the beginning of the week showed no significant change between baseline and 3 months (1.3 ± 0.5 kg vs. 1.2 ± 0.4 kg, p = 0.62). Similarly, blood pressure fluctuations during dialysis at the beginning of the week did not significantly change (1.1 ± 0.7 vs. 1.5 ± 0.8, p = 0.17). Among the blood biochemical parameters, hemoglobin levels significantly increased from 10.8 ± 1.0 g/dL at baseline to 11.8 ± 1.0 g/dL at 3 months ( p = 0.02). In contrast, no significant changes were observed in albumin (3.6 ± 0.2 vs. 3.7 ± 0.2 g/dL, p = 0.14), LDL cholesterol (83.1 ± 29.9 vs. 84.2 ± 31.4 mg/dL, p = 0.41), or inorganic phosphorus levels (4.8 ± 1.2 vs. 4.8 ± 1.0 mg/dL, p = 0.50). Health Consciousness The total score of the Health Consciousness Scale significantly decreased from 36.5 ± 7.7 at baseline to 31.8 ± 7.8 at 3 months ( p < 0.05). Significant changes were observed in several areas, including interest in health (Q2), awareness of health-related issues (Q3), time spent on health-related activities (Q5), indifference toward prevention (Q11), and dependence on medical treatment (Q12). These findings suggest changes in participants’ perceptions and attitudes toward health during the study period ( Table 5 ). Frailty Status Frailty status assessed using the Kihon Checklist showed a decrease in the total score from 6.8 ± 4.2 at baseline to 5.4 ± 1.3 in 3 months, although the difference did not reach statistical significance ( p = 0.06). Among the subdomains, depressive mood showed the greatest reduction (2.0 ± 1.9 vs. 1.0 ± 1.3, p = 0.05), suggesting a possible improvement in psychological well-being ( Table 5 ). eHealth literacy did not show a significant change before and after the use of the digital self-management application. Discussion Participant attributes In this pilot study of patients undergoing maintenance hemodialysis, use of a digital self-management application for 3 months was associated with a significant increase in hemoglobin levels, significant changes in several health consciousness items, and a trend toward improvement in frailty-related status, particularly depressive symptoms. These findings are clinically relevant because patients receiving hemodialysis require complex day-to-day self-management, and patient-centered kidney care increasingly emphasizes outcomes beyond survival alone, including symptom burden, well-being, and functional status ( 17 ). Interpretation of clinical findings The significant increase in hemoglobin may indicate improved engagement with daily health management during the intervention period; however, this finding should be interpreted cautiously because other clinical parameters, including albumin, LDL-C, and inorganic phosphorus remained unchanged. Furthermore, no changes were observed in dialysis management parameters such as interdialytic weight gain and intradialytic blood pressure fluctuation. This pattern is consistent with the broader CKD digital health literature, in which digital interventions often show promising effects on self-monitoring, engagement, and care processes, while effects on hard clinical outcomes remain inconsistent or modest, especially in small studies and short follow-up periods ( 18 ). Interpretation of health consciousness findings The observed changes in the Health Consciousness Scale suggest that the application may have influenced how participants perceived and engaged in their own health. Digital health tools that collect, aggregate, and visualize personal data can make health status more visible to patients and may promote reflection, self-awareness, and day-to-day engagement in disease management. Although the total score decreased, the significant changes observed in specific items may suggest a recalibration of self-perception and a reduction in passive dependence on medical care ( 17 ). Relevance of eHealth literacy and self-management Our findings are also plausible in light of recent evidence showing that patients undergoing maintenance hemodialysis often have suboptimal eHealth literacy and that education, income, and related social factors influence their ability to use digital health information effectively. Because eHealth literacy is closely linked to the ability to obtain, understand, evaluate, and apply health information for treatment adherence and self-management, even a simple app-based intervention that encourages regular self-monitoring may help strengthen patient engagement with health behaviors ( 17 ). Frailty and psychological implications Although the reduction in the total frailty score did not reach statistical significance, the direction of change and the decrease in depressive symptoms are noteworthy. Frailty is highly prevalent in dialysis populations and is closely connected with functional decline, symptom burden, an17d poor quality of life ( 19 , 20 ). Prior studies in hemodialysis populations have shown that interventions supporting active participation in care, including exercise-based self-management approaches, may improve physical and psychological functioning, which is consistent with the possibility that digital self-monitoring may have favorable effects on mood and perceived control ( 21 ). Clinical implications Taken together, these findings suggest that digital self-management tools may be most useful not as stand-alone treatments for changing biochemical outcomes rapidly, but as supportive interventions that enhance patient awareness, engagement, and potentially psychological well-being. This interpretation aligns with recent reviews in CKD showing that digital interventions may improve aspects of care delivery, feasibility, and patient participation, even when measurable clinical benefits are small or heterogeneous ( 18 ). Study limitations This study has several limitations. First, the sample size was very small, limiting statistical power and increasing the risk of both type I and type II errors. Second, the study was conducted at a single site, which may limit generalizability. Third, the absence of a control group precludes causal inference, and some observed changes may reflect temporal variation rather than intervention effects. These limitations are particularly important in digital health research in CKD, where uptake, feasibility, and effect sizes vary substantially across settings and populations ( 18 ). Conclusions In conclusion, this pilot study suggests that digital self-management application may influence health awareness and selected patient-centered outcomes in maintenance hemodialysis patients, with possible benefits for psychological aspects of frailty. Larger, controlled, multicenter studies are needed to determine whether such interventions can produce sustained improvements in self-management, frailty, and clinically meaningful outcomes in dialysis care. Declarations The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. Ethics approval and consent to participate This study was approved by the Institutional Review Board (IRB) Research Ethics Committee of the Faculty of Health Science and Nursing at Juntendo University (IRB approval number 6 − 005) and the Toyu Medical Research Ethics Review Committee of the Medical Corporation Showakaii (IRB approval number 2024S-13 and 2024S-15). Written informed consent was obtained from all participants. Consent for publication Not applicable. Competing interest s The authors declare that they have no competing interests. Funding This study was supported by a Grant-in-Aid for Scientific Research (KAKENHI) from the Japan Society for the Promotion of Science (JSPS) (Grant Number: [21K10808]). The funding body had no role in the design of the study, data collection, analysis, interpretation of data, or writing of the manuscript. Author Contribution All authors contributed to the study conception and design. Data collection was performed by Mitsumine Fukui, Reo Kanada, Atsuko Urita and Yasuhiko Tomino. All authors read and approved of the final manuscript. Acknowledgement AcknowledgementsThe authors would like to express their sincere appreciation to Ms. Sachiko Iwama, medical social worker at Tajimabashi Clinic, for her invaluable support and assistance in the implementation of this study. Data Availability The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. References Curtin RB, Mapes DL. Health care management strategies of long-term dialysis survivors. Nephrol Nurs J. 2001;28(4):385–92. Griva K, Lai AY, Lim HA et al. Non-adherence in patients on peritoneal dialysis: a systematic review. PLoS One. 25;9(2):e89001. 2014. doi: 10.1371. Tong A, Sainsbury P, Carter SM, et al. Patients' priorities for health research: focus group study of patients with chronic kidney disease. Nephrol Dial Transpl. 2008;23(10):3206–14. 10.1093. Green JA, Mor MK, Shields AM, et al. Associations of health literacy with dialysis adherence and health resource utilization in patients receiving maintenance hemodialysis. Am J Kidney Dis. 2013;62(1):73–80. 10.1053. Taylor DM, Fraser S, Dudley C, et al. Health literacy and patient outcomes in chronic kidney disease: a systematic review. Nephrol Dial Transpl. 2018;33(9):1545–58. Shen H, van der Kleij R, van der Boog PJM, et al. Internet-based self-management interventions for patients with chronic kidney disease: a systematic review and meta-analysis. J Med Internet Res. 2019;21(7):e13342. 10.2196. Graham-Brown MPM, Thompson S, McIntyre CW. Digital health interventions in chronic kidney disease: a systematic review. Kidney Int Rep. 2022;7(2):123–34. Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013;32(2):207–14. Marcolino MS, Oliveira JAQ, D’Agostino M, Ribeiro AL, Alkmim MBM, Novillo-Ortiz D. The impact of mHealth interventions: systematic review of systematic reviews. J Med Internet Res. 2018;20(1):e23. Diamantidis CJ, Ginsberg JS, Yoffe M, Lucas GM, Prakash K, Aggarwal S, et al. Mobile health technology use and patient-reported outcomes in CKD: a systematic review. Clin J Am Soc Nephrol. 2019;14(3):465–72. Bonner A, Gillespie K, Campbell KL, Corones-Watkins K, Hayes B, Harvie B, et al. Evaluating the use of digital health interventions in kidney disease: a systematic review. Kidney Int Rep. 2020;5(4):452–65. Jayanti RK, Burns AC. The antecedents of preventive health care behavior: an empirical study. J Acad Mark Sci. 1998;26:6–15. Kraft FB, Goodell PW. Identifying the health conscious consumer. Int J Consum Stud. 2008;32:163–70. Chie OZAWA, Hirono ISHIKAWA, Mio KATO, Yoshiharu FUKUDA. Development of the Interest in Health Scale to understand the population indifferent to health. JJHEP. 2021;20(3):266–77. Norman CD, Skkinner HA. eHEALS: The e Health Literacy Scale.Jpurnal of Medical J Med Internet Res. 8(4): e27,2006. 10.2196 Satake S, Senda K, Hpng YJ, et al. Validity of the Kihon Checklist for assessing frailty status. Geriatr Gerontol Int. 2016;16(6):709–15. 10.1111. Han X, Yang L, Zhang H. e-Health Literacy in Maintenance Hemodialysis Patients: A Multi-Center Cross-Sectional Study. Patient Prefer Adherence. 2025;27:19:3339–48. 10.2147. Hui M, Zhang D, Ye L, et al. Digital Health Interventions for Quality Improvements in Chronic Kidney Disease Primary Care: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2024;13(2):364. 10.3390. Bao Y, Dalrymple L, Chertow GM et al. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 23;172(14):1071-7. 2012. 10.1001 Kojima G. Prevalence of frailty in end-stage renal disease: a systematic review and meta-analysis. Int Urol Nephrol. 2017;49(11):1989–97. 10.1007. Kennard A, Rainsford S, Glassgow N et al. Use of frailty assessment instruments in nephrology populations: a scoping review. BMC Geriatr. 21;23(1):449. 2023. 10.1186 Tables Table 1 to 5 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files 202603200222DigitalInterventionsforDialysisSelfCareBMCNephrologyTables.docx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 14 May, 2026 Reviews received at journal 14 May, 2026 Reviews received at journal 04 May, 2026 Reviews received at journal 02 May, 2026 Reviewers agreed at journal 28 Apr, 2026 Reviewers agreed at journal 26 Apr, 2026 Reviewers agreed at journal 23 Apr, 2026 Reviewers invited by journal 22 Apr, 2026 Editor invited by journal 13 Apr, 2026 Editor assigned by journal 13 Apr, 2026 Submission checks completed at journal 13 Apr, 2026 First submitted to journal 08 Apr, 2026 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9355105","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":633496083,"identity":"5daf7c21-ec92-4aab-9380-9e02230a6259","order_by":0,"name":"Chieko HAMADA","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6klEQVRIie3QPQrCMBiA4a8EdKl2bRH0CilZi2exBOoqCOJYKcRFcA14Cb2BUtCl1DWgS/AE4iQupoqgS8womHdJvuEhPwA22y/mO6mTQoSeU+25YAOSKIKMCYAiOXwQbd4im0g+3tfxYb45DUYReNM1DAe6Q46bLFwWB4SPOSK8TMAvekC4hmA/ZoFkighaazWYuqEAIK6eTK+SlRWp3yrSMSDMWbH14xRUEfyN+CLOAl5QFAhKWm6ZuGERp9q3eLwvz7NxlzZFLC/uKGq3d/mW6H7sFX1t1JUcRgwEdN8HdDIhNpvN9jfdAUH8SaWOrKeKAAAAAElFTkSuQmCC","orcid":"","institution":"Juntendo University","correspondingAuthor":true,"prefix":"","firstName":"Chieko","middleName":"","lastName":"HAMADA","suffix":""},{"id":633496084,"identity":"5117507b-d4cb-4c96-9cc2-5badf45ad602","order_by":1,"name":"Mitsumine FUKUI","email":"","orcid":"","institution":"Medical Corporation SHOWAKAI","correspondingAuthor":false,"prefix":"","firstName":"Mitsumine","middleName":"","lastName":"FUKUI","suffix":""},{"id":633496085,"identity":"7a775c20-2e89-41e4-9aa0-c65625186b7e","order_by":2,"name":"Yasuhiko TOMINO","email":"","orcid":"","institution":"Medical Corporation SHOWAKAI","correspondingAuthor":false,"prefix":"","firstName":"Yasuhiko","middleName":"","lastName":"TOMINO","suffix":""},{"id":633496086,"identity":"4d526356-7d65-4b86-a789-5baa014e9d31","order_by":3,"name":"Reo KANDA","email":"","orcid":"","institution":"Medical Corporation SHOWAKAI","correspondingAuthor":false,"prefix":"","firstName":"Reo","middleName":"","lastName":"KANDA","suffix":""},{"id":633496087,"identity":"bdbb68eb-9fcb-4637-9ef6-2a78e30b9d96","order_by":4,"name":"Atsuko URITA","email":"","orcid":"","institution":"Medical Corporation SHOWAKAI","correspondingAuthor":false,"prefix":"","firstName":"Atsuko","middleName":"","lastName":"URITA","suffix":""}],"badges":[],"createdAt":"2026-04-08 09:56:49","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9355105/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9355105/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":108806752,"identity":"5042f793-b9c8-4440-88d8-a20742c29985","added_by":"auto","created_at":"2026-05-08 15:29:21","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":43025,"visible":true,"origin":"","legend":"\u003cp\u003eConceptual framework\u003c/p\u003e\n\u003cp\u003eStudy design of the present study. Patients undergoing maintenance hemodialysis were assessed at baseline, followed by a 3-month digital self-management intervention using a mobile application. Clinical parameters, health consciousness, eHealth literacy, and frailty status were evaluated before and after the intervention. Subgroup analyses were conducted based on application usage levels.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-9355105/v1/afcc768d06be582efd79f1df.png"},{"id":108976692,"identity":"3cb2a447-db27-4f68-bcdb-c1031e4b87e8","added_by":"auto","created_at":"2026-05-11 11:28:08","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":199613,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9355105/v1/cc99bb4c-8e99-4a95-8b51-441e17f0368e.pdf"},{"id":108734145,"identity":"19de1a2c-0bd8-4728-a314-110babebddd1","added_by":"auto","created_at":"2026-05-07 19:49:22","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":40069,"visible":true,"origin":"","legend":"","description":"","filename":"202603200222DigitalInterventionsforDialysisSelfCareBMCNephrologyTables.docx","url":"https://assets-eu.researchsquare.com/files/rs-9355105/v1/8bb6503736d3d8f814269660.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Digital Self-Management Application for Patients Undergoing Hemodialysis: Effects on Health Awareness and Frailty","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePatients undergoing maintenance hemodialysis are required to adhere to complex treatment regimens, including strict control of fluid intake, dietary potassium and phosphorus restriction, medication adherence, and management of multiple comorbidities such as cardiovascular disease and diabetes. These demands place a substantial burden on patients and make effective self-management a central component of dialysis care. Poor self-management has been associated with increased hospitalization, complications, and reduced quality of life among dialysis patients (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eTraditionally, dialysis care has focused primarily on clinical outcomes such as survival and biochemical control. However, recent shifts toward patient-centered care emphasize broader outcomes including well-being, quality of life, and patient engagement in health management. In this context, patients are increasingly expected to actively participate in managing their health and daily life rather than passively following medical instructions (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eHealth literacy plays a critical role in enabling patients with chronic diseases to engage in effective self-management. Health literacy encompasses the ability to obtain, understand, evaluate, and apply health information to make appropriate health decisions. Previous studies have shown that inadequate health literacy is common among patients with chronic kidney disease and dialysis and is associated with poorer health outcomes, reduced treatment adherence, and increased mortality (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eWith the rapid expansion of digital health technologies, electronic health literacy (eHealth literacy) has emerged as an important extension of health literacy. eHealth literacy refers to the ability to seek, evaluate, and apply health information obtained through digital platforms such as the internet, mobile applications, and online health services. Digital health interventions\u0026mdash;including mobile health applications, remote monitoring systems, and telehealth programs\u0026mdash;have increasingly been introduced to support self-management in chronic diseases (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn nephrology, digital health interventions have shown promising potential for improving patient engagement, treatment adherence, and quality of life in individuals with chronic kidney disease and dialysis therapy. Several studies have reported that mobile health applications and digital monitoring systems can enhance patient participation in health management and support behavioral changes necessary for effective self-management (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eHowever, engagement with digital health technologies varies widely among patients. Emerging evidence suggests that proactive health awareness, defined as an individual\u0026rsquo;s active interest in maintaining and improving their health, may be a key determinant of digital health utilization and eHealth literacy. Individuals with higher health awareness are more likely to actively seek health information, critically evaluate digital resources, and apply acquired knowledge to their daily health behaviors (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDespite increasing attention to digital health interventions in nephrology, the relationships between health awareness, eHealth literacy, and health-related outcomes in maintenance dialysis patients remain insufficiently understood (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). In particular, little is known about how these factors relate to frailty status and the acceptability of digital self-management tools among dialysis populations, who are often older and medically complex (10.11).\u003c/p\u003e \u003cp\u003eTherefore, the present study aimed to investigate the relationship between health awareness and eHealth literacy in patients undergoing maintenance hemodialysis, and to examine their associations with frailty status. In addition, this study explored the acceptability of a digital self-management application and evaluated whether digital health interventions may facilitate behavioral changes in health management and contribute to improving eHealth literacy. By clarifying these relationships, this study may provide evidence supporting the development of digital health strategies that promote patient-centered self-management and contribute to a paradigm shift in dialysis care.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cu\u003eStudy Design and Participants (Figure 1)\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThis study was designed as a cross-sectional observational study conducted at an outpatient dialysis center. Patients aged \u0026ge;20 years who had been receiving maintenance hemodialysis three times per week for at least 3 months were eligible for participation. Patients were recruited from outpatient dialysis units during the study period. Individuals who were unable to provide informed consent, had severe cognitive impairment, or had acute medical conditions that could affect participation were excluded. All participants provided written informed consent prior to enrollment.\u003c/p\u003e\n\u003cp\u003eA health self-management application was used to support participants\u0026rsquo; daily health monitoring. The application automatically collected physical activity data, including step counts and the number of flights of stairs climbed, using smartphone sensors. Participants also entered health parameters such as blood pressure and body weight. In addition, weekly health status-including physical condition, sleep quality, dietary intake, and mental well-being-was recorded using a standardized scale. Optional behavioral stamps allowed users to record health-related activities. All collected data were visualized within the application interface on a daily or weekly basis, enabling users to monitor their health status and observe trends over time, thereby supporting self-management behaviors.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eEthical Considerations\u003c/u\u003e\u003cbr\u003e\u0026nbsp;This study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the institutional ethics committee of the participating each institution (IRB approval number for Juntendo University Faculty of Health Sciences and Nursing: 6-005, IRB approval numbers for Medical Corporation SHOWAKAI: 2024S-13 and 2024S-15). Written informed consent was obtained from all participants prior to participation.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eData Collection\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eData were collected from medical records, physical assessments, and self-administered questionnaires. Clinical information was obtained from patients\u0026rsquo; medical records and included blood biochemical parameters, interdialytic weight gain (IDWG) at the beginning of the week, blood pressure fluctuations during dialysis at the beginning of the week, and the number and types of prescribed medications. These indicators were used to evaluate clinical status and dialysis-related management.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003ePhysical Assessment\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003ePhysical function was assessed using grip strength, which is widely used as an indicator of muscle strength and frailty in patients with chronic diseases. Grip strength was measured using a hand dynamometer according to standardized measurement procedures.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eQuestionnaire Assessments\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eParticipants completed self-administered questionnaires assessing health awareness （Table 1）, digital health literacy, and frailty. Health awareness was assessed using the Japanese version of the Health Interest Scale developed by Ozawa et al., which is based on elements of health awareness scales (12,13) and health motivation scales (12), which are similar concepts to health interest (14). Digital health literacy was assessed using eHealth Literacy Scale (eHEALS) (Table 2), which evaluates individuals perceived ability to seek, understand, evaluate, and apply health information obtained from electronic sources (15). Frailty status was assessed using the Kihon Checklist (Table 3a and 3b), a self-reported screening questionnaire developed by the Japanese Ministry of Health, Labor and Welfare that evaluates multiple domains, including physical function, nutritional status, social activity, and cognitive function (16).\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eEthical Considerations\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board (IRB) Research Ethics Committee of the Faculty of Health Science and Nursing at Juntendo University (IRB approval number 6-005) and the Toyu Medical Research Ethics Review Committee of the Medical Corporation Showakaii (IRB approval number 2024S-13, 2024S-15). Written informed consent was obtained from all participants prior to participation.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eStatistical Analysis\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eContinuous variables are presented as mean \u0026plusmn; standard deviation or median (interquartile range), depending on data distribution. Categorical variables are presented as frequencies and percentages. Group comparisons were performed using the Student\u0026rsquo;s t-test or Mann\u0026ndash;Whitney U test for continuous variables and the chi-square test for categorical variables. Correlation analyses were conducted to examine the relationships between health consciousness, eHealth literacy, and frailty-related variables. Multiple regression analysis was performed to identify factors independently associated with eHealth literacy and health management behaviors. All statistical analyses were performed using statistical software, and a two-sided P value \u0026lt;0.05 was considered statistically significant.\u003c/p\u003e\n\u003cp\u003eThis study was reported in accordance with the STROBE guidelines.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cu\u003eParticipants (Table 4)\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThe study included 12 patients undergoing maintenance hemodialysis (9 men and 3 women). The mean age was 65.4 \u0026plusmn; 6.4 years, and the mean dialysis duration was 5.9 \u0026plusmn; 8.1 years. The primary cause of dialysis initiation was diabetic nephropathy in six patients. Regarding medical history, one patient had a history of stroke, two had ischemic heart disease, two had malignant tumors, and one had a history of fracture. The mean number of prescribed medications at baseline was 9.3 \u0026plusmn; 3.7 types. In terms of social background, one patient lived alone, three lived with a spouse only, and eight lived with family members. Regarding educational attainment, three patients had graduated from university and nine had graduated from high school. With respect to employment status, one patient was a full-time employee, three were self-employed, one was a non-regular employee, and seven were pensioners. Annual income was less than 4 million yen in six patients and 4 million yen or more in six patients.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eClinical Outcomes\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eChanges in clinical parameters before and after the intervention are summarized in \u003cu\u003eTable 5\u003c/u\u003e. The mean number of prescribed medications slightly decreased from 9.3 \u0026plusmn; 3.7 at baseline to 8.5 \u0026plusmn; 3.4 in 3 months, although the difference was not statistically significant (\u003cem\u003ep\u003c/em\u003e = 0.21). During the study period, hospitalization occurred in four patients; however, these hospitalizations were related to treatment for previously diagnosed malignancy (n = 1) and arteriovenous fistula dysfunction (n = 3). Interdialytic weight gain at the beginning of the week showed no significant change between baseline and 3 months (1.3 \u0026plusmn; 0.5 kg vs. 1.2 \u0026plusmn; 0.4 kg, \u003cem\u003ep\u003c/em\u003e = 0.62). Similarly, blood pressure fluctuations during dialysis at the beginning of the week did not significantly change (1.1 \u0026plusmn; 0.7 vs. 1.5 \u0026plusmn; 0.8, \u003cem\u003ep\u003c/em\u003e = 0.17).\u003c/p\u003e\n\u003cp\u003eAmong the blood biochemical parameters, hemoglobin levels significantly increased from 10.8 \u0026plusmn; 1.0 g/dL at baseline to 11.8 \u0026plusmn; 1.0 g/dL at 3 months (\u003cem\u003ep\u003c/em\u003e = 0.02). In contrast, no significant changes were observed in albumin (3.6 \u0026plusmn; 0.2 vs. 3.7 \u0026plusmn; 0.2 g/dL, \u003cem\u003ep\u003c/em\u003e = 0.14), LDL cholesterol (83.1 \u0026plusmn; 29.9 vs. 84.2 \u0026plusmn; 31.4 mg/dL, \u003cem\u003ep\u003c/em\u003e = 0.41), or inorganic phosphorus levels (4.8 \u0026plusmn; 1.2 vs. 4.8 \u0026plusmn; 1.0 mg/dL, \u003cem\u003ep\u003c/em\u003e = 0.50).\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eHealth Consciousness\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThe total score of the Health Consciousness Scale significantly decreased from 36.5 \u0026plusmn; 7.7 at baseline to 31.8 \u0026plusmn; 7.8 at 3 months (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05). Significant changes were observed in several areas, including interest in health (Q2), awareness of health-related issues (Q3), time spent on health-related activities (Q5), indifference toward prevention (Q11), and dependence on medical treatment (Q12). These findings suggest changes in participants\u0026rsquo; perceptions and attitudes toward health during the study period (\u003cu\u003eTable 5\u003c/u\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eFrailty Status\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eFrailty status assessed using the Kihon Checklist showed a decrease in the total score from 6.8 \u0026plusmn; 4.2 at baseline to 5.4 \u0026plusmn; 1.3 in 3 months, although the difference did not reach statistical significance (\u003cem\u003ep\u003c/em\u003e = 0.06). Among the subdomains, depressive mood showed the greatest reduction (2.0 \u0026plusmn; 1.9 vs. 1.0 \u0026plusmn; 1.3, \u003cem\u003ep\u003c/em\u003e = 0.05), suggesting a possible improvement in psychological well-being (\u003cu\u003eTable 5\u003c/u\u003e).\u003c/p\u003e\n\u003cp\u003eeHealth literacy did not show a significant change before and after the use of the digital self-management application.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eParticipant attributes\u003c/h2\u003e \u003cp\u003eIn this pilot study of patients undergoing maintenance hemodialysis, use of a digital self-management application for 3 months was associated with a significant increase in hemoglobin levels, significant changes in several health consciousness items, and a trend toward improvement in frailty-related status, particularly depressive symptoms. These findings are clinically relevant because patients receiving hemodialysis require complex day-to-day self-management, and patient-centered kidney care increasingly emphasizes outcomes beyond survival alone, including symptom burden, well-being, and functional status (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eInterpretation of clinical findings\u003c/h2\u003e \u003cp\u003eThe significant increase in hemoglobin may indicate improved engagement with daily health management during the intervention period; however, this finding should be interpreted cautiously because other clinical parameters, including albumin, LDL-C, and inorganic phosphorus remained unchanged. Furthermore, no changes were observed in dialysis management parameters such as interdialytic weight gain and intradialytic blood pressure fluctuation. This pattern is consistent with the broader CKD digital health literature, in which digital interventions often show promising effects on self-monitoring, engagement, and care processes, while effects on hard clinical outcomes remain inconsistent or modest, especially in small studies and short follow-up periods (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eInterpretation of health consciousness findings\u003c/h2\u003e \u003cp\u003eThe observed changes in the Health Consciousness Scale suggest that the application may have influenced how participants perceived and engaged in their own health. Digital health tools that collect, aggregate, and visualize personal data can make health status more visible to patients and may promote reflection, self-awareness, and day-to-day engagement in disease management. Although the total score decreased, the significant changes observed in specific items may suggest a recalibration of self-perception and a reduction in passive dependence on medical care (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eRelevance of eHealth literacy and self-management\u003c/h2\u003e \u003cp\u003eOur findings are also plausible in light of recent evidence showing that patients undergoing maintenance hemodialysis often have suboptimal eHealth literacy and that education, income, and related social factors influence their ability to use digital health information effectively. Because eHealth literacy is closely linked to the ability to obtain, understand, evaluate, and apply health information for treatment adherence and self-management, even a simple app-based intervention that encourages regular self-monitoring may help strengthen patient engagement with health behaviors (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eFrailty and psychological implications\u003c/h2\u003e \u003cp\u003eAlthough the reduction in the total frailty score did not reach statistical significance, the direction of change and the decrease in depressive symptoms are noteworthy. Frailty is highly prevalent in dialysis populations and is closely connected with functional decline, symptom burden, an17d poor quality of life (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Prior studies in hemodialysis populations have shown that interventions supporting active participation in care, including exercise-based self-management approaches, may improve physical and psychological functioning, which is consistent with the possibility that digital self-monitoring may have favorable effects on mood and perceived control (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eClinical implications\u003c/h2\u003e \u003cp\u003eTaken together, these findings suggest that digital self-management tools may be most useful not as stand-alone treatments for changing biochemical outcomes rapidly, but as supportive interventions that enhance patient awareness, engagement, and potentially psychological well-being. This interpretation aligns with recent reviews in CKD showing that digital interventions may improve aspects of care delivery, feasibility, and patient participation, even when measurable clinical benefits are small or heterogeneous (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eStudy limitations\u003c/h2\u003e \u003cp\u003eThis study has several limitations. First, the sample size was very small, limiting statistical power and increasing the risk of both type I and type II errors. Second, the study was conducted at a single site, which may limit generalizability. Third, the absence of a control group precludes causal inference, and some observed changes may reflect temporal variation rather than intervention effects. These limitations are particularly important in digital health research in CKD, where uptake, feasibility, and effect sizes vary substantially across settings and populations (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn conclusion, this pilot study suggests that digital self-management application may influence health awareness and selected patient-centered outcomes in maintenance hemodialysis patients, with possible benefits for psychological aspects of frailty. Larger, controlled, multicenter studies are needed to determine whether such interventions can produce sustained improvements in self-management, frailty, and clinically meaningful outcomes in dialysis care.\u003c/p\u003e"},{"header":"Declarations","content":" \u003cp\u003eThe datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e \u003cp\u003e This study was approved by the Institutional Review Board (IRB) Research Ethics Committee of the Faculty of Health Science and Nursing at Juntendo University (IRB approval number 6\u0026thinsp;\u0026minus;\u0026thinsp;005) and the Toyu Medical Research Ethics Review Committee of the Medical Corporation Showakaii (IRB approval number 2024S-13 and 2024S-15). Written informed consent was obtained from all participants.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent for publication\u003c/strong\u003e \u003cp\u003eNot applicable.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003e \u003cb\u003eCompeting interest\u003c/b\u003es\u003c/strong\u003e \u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis study was supported by a Grant-in-Aid for Scientific Research (KAKENHI) from the Japan Society for the Promotion of Science (JSPS) (Grant Number: [21K10808]). The funding body had no role in the design of the study, data collection, analysis, interpretation of data, or writing of the manuscript.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAll authors contributed to the study conception and design. Data collection was performed by Mitsumine Fukui, Reo Kanada, Atsuko Urita and Yasuhiko Tomino. All authors read and approved of the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eAcknowledgementsThe authors would like to express their sincere appreciation to Ms. Sachiko Iwama, medical social worker at Tajimabashi Clinic, for her invaluable support and assistance in the implementation of this study.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eCurtin RB, Mapes DL. Health care management strategies of long-term dialysis survivors. Nephrol Nurs J. 2001;28(4):385\u0026ndash;92.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGriva K, Lai AY, Lim HA et al. 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Int J Consum Stud. 2008;32:163\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChie OZAWA, Hirono ISHIKAWA, Mio KATO, Yoshiharu FUKUDA. Development of the Interest in Health Scale to understand the population indifferent to health. JJHEP. 2021;20(3):266\u0026ndash;77.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNorman CD, Skkinner HA. eHEALS: The e Health Literacy Scale.Jpurnal of Medical J Med Internet Res. 8(4): e27,2006. 10.2196\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSatake S, Senda K, Hpng YJ, et al. Validity of the Kihon Checklist for assessing frailty status. Geriatr Gerontol Int. 2016;16(6):709\u0026ndash;15. 10.1111.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHan X, Yang L, Zhang H. e-Health Literacy in Maintenance Hemodialysis Patients: A Multi-Center Cross-Sectional Study. Patient Prefer Adherence. 2025;27:19:3339\u0026ndash;48. 10.2147.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHui M, Zhang D, Ye L, et al. Digital Health Interventions for Quality Improvements in Chronic Kidney Disease Primary Care: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2024;13(2):364. 10.3390.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBao Y, Dalrymple L, Chertow GM et al. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 23;172(14):1071-7. 2012. 10.1001\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKojima G. Prevalence of frailty in end-stage renal disease: a systematic review and meta-analysis. Int Urol Nephrol. 2017;49(11):1989\u0026ndash;97. 10.1007.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKennard A, Rainsford S, Glassgow N et al. Use of frailty assessment instruments in nephrology populations: a scoping review. BMC Geriatr. 21;23(1):449. 2023. 10.1186\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 to 5 are available in the Supplementary Files section.\u003c/p\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":"bmc-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bnep","sideBox":"Learn more about [BMC Nephrology](http://bmcnephrol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bnep/default.aspx","title":"BMC Nephrology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Dialysis patients, Self-management, Digital health intervention, eHealth literacy, Patient engagement","lastPublishedDoi":"10.21203/rs.3.rs-9355105/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9355105/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e \u003cp\u003eDigital health interventions are increasingly used to support self-management in patients with chronic diseases; however, their impact on patient-centered outcomes, including health awareness and frailty, in maintenance hemodialysis populations remains insufficiently understood. This study aimed to evaluate the multidimensional effects of a digital self-management application on clinical and patient-reported outcomes.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis prospective observational study included 12 patients undergoing maintenance hemodialysis. A digital self-management application was introduced for 3 months to support daily health monitoring. The application combined automatic data collection (physical activity) and patient-reported inputs (vital signs, weekly health status, and behavioral tracking). Clinical parameters, health consciousness, eHealth literacy\u0026ndash;related behaviors, and frailty assessed by the Kihon Checklist were evaluated at baseline and after the intervention.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe mean age of participants was 65.4\u0026thinsp;\u0026plusmn;\u0026thinsp;6.4 years, and the mean dialysis duration was 5.9\u0026thinsp;\u0026plusmn;\u0026thinsp;8.1 years. Hemoglobin levels significantly increased from 10.8\u0026thinsp;\u0026plusmn;\u0026thinsp;1.0 g/dL to 11.8\u0026thinsp;\u0026plusmn;\u0026thinsp;1.0 g/dL (p\u0026thinsp;=\u0026thinsp;0.02), while other clinical parameters showed no significant changes. The total Health Consciousness Scale score significantly decreased from 36.5\u0026thinsp;\u0026plusmn;\u0026thinsp;7.7 to 31.8\u0026thinsp;\u0026plusmn;\u0026thinsp;7.8 (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05), indicating changes in health-related perceptions and attitudes. Frailty scores showed a reduction from 6.8\u0026thinsp;\u0026plusmn;\u0026thinsp;4.2 to 5.4\u0026thinsp;\u0026plusmn;\u0026thinsp;1.3, suggesting a trend toward improvement (p\u0026thinsp;=\u0026thinsp;0.06), with the greatest improvement observed in depressive symptoms.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e \u003cp\u003eA digital self-management application may influence both clinical indicators and patient-centered outcomes, particularly health awareness and psychological aspects of frailty, in patients undergoing maintenance hemodialysis. These findings suggest that digital interventions may enhance patient engagement and support a shift toward patient-centered dialysis care, warranting further investigation in larger studies.\u003c/p\u003e","manuscriptTitle":"Digital Self-Management Application for Patients Undergoing Hemodialysis: Effects on Health Awareness and Frailty","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-05-07 19:49:16","doi":"10.21203/rs.3.rs-9355105/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-05-14T21:33:50+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-14T18:17:57+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-04T15:11:29+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-02T13:17:31+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"197416424146041995318491520313359721506","date":"2026-04-28T05:37:51+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"152229496602282810153802382175414792703","date":"2026-04-26T12:37:50+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"12986723556679489788472232349956336287","date":"2026-04-23T09:22:42+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-23T02:48:07+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-04-13T16:25:41+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-13T10:54:40+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-13T10:54:24+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Nephrology","date":"2026-04-08T09:35:39+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bnep","sideBox":"Learn more about [BMC Nephrology](http://bmcnephrol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bnep/default.aspx","title":"BMC Nephrology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"31e3ee0e-ba3f-476d-ad05-1e248536c4b9","owner":[],"postedDate":"May 7th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Revision requested","date":"2026-05-14T21:33:50+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-14T18:17:57+00:00","index":36,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-04T15:11:29+00:00","index":35,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-02T13:17:31+00:00","index":34,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-18T11:23:34+00:00","versionOfRecord":[],"versionCreatedAt":"2026-05-07 19:49:16","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9355105","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9355105","identity":"rs-9355105","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}