PMID- 37163342 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231002 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 12 DP - 2023 May 10 TI - Sensor-Controlled Digital Game for Heart Failure Self-management: Protocol for a Randomized Controlled Trial. PG - e45801 LID - 10.2196/45801 [doi] LID - e45801 AB - BACKGROUND: Heart failure (HF) is the leading cause of hospitalization among older adults in the United States. There are substantial racial and geographic disparities in HF outcomes, with patients living in southern US states having a mortality rate 69% higher than the national average. Self-management behaviors, particularly daily weight monitoring and physical activity, are extremely important in improving HF outcomes; however, patients typically have particularly low adherence to these behaviors. With the rise of digital technologies to improve health outcomes and motivate health behaviors, sensor-controlled digital games (SCDGs) have become a promising approach. SCDGs, which leverage sensor-connected technologies, offer the benefits of being portable and scalable and allowing for continuous observation and motivation of health behaviors in their real-world contexts. They are also becoming increasingly popular among older adults and offer an immersive and accessible way to measure self-management behaviors and improve adherence. No SCDGs have been designed for older adults or evaluated to test their outcomes. OBJECTIVE: This randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity tracker sensors to activate game progress, rewards, and feedback and, ultimately, to improve adherence to important self-management behaviors. METHODS: A total of 200 participants with HF, aged >/=45 years, will be recruited and randomized into 2 groups: the SCDG playing group (intervention group) and sensor-only group (control group). Both groups will receive a weight scale, physical activity tracker, and accompanying app, whereas only the intervention group will play the SCDG. This design, thereby, assesses the contributions of the game. All participants will complete a baseline survey as well as posttests at 6 and 12 weeks to assess the immediate effect of the intervention. They will also complete a third posttest at 24 weeks to assess the maintenance of behavioral changes. Efficacy and benefits will be assessed by measuring improvements in HF-related proximal outcomes (self-management behaviors of daily weight monitoring and physical activity) and distal outcomes (HF hospitalization, quality of life, and functional status) between baseline and weeks 6, 12, and 24. The primary outcome measured will be days with weight monitoring, for which this design provides at least 80% power to detect differences between the 2 groups. RESULTS: Recruitment began in the fall of 2022, and the first patient was enrolled in the study on November 7, 2022. Recruitment of the last participant is expected in quarter 1 of 2025. Publication of complete results and data from this study is expected in 2026. CONCLUSIONS: This project will generate insight and guidance for scalable and easy-to-use digital gaming solutions to motivate persistent adherence to HF self-management behaviors and improve health outcomes among individuals with HF. TRIAL REGISTRATION: ClinicalTrials.gov NCT05056129; https://clinicaltrials.gov/ct2/show/NCT05056129. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45801. CI - (c)Kavita Radhakrishnan, Christine Julien, Matthew O'Hair, Rachel Tunis, Grace Lee, Angelica Rangel, James Custer, Tom Baranowski, Paul J Rathouz, Miyong T Kim. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.05.2023. FAU - Radhakrishnan, Kavita AU - Radhakrishnan K AUID- ORCID: 0000-0002-1373-1633 AD - School of Nursing, The University of Texas at Austin, Austin, TX, United States. FAU - Julien, Christine AU - Julien C AUID- ORCID: 0000-0002-4131-4642 AD - Department of Electrical and Computer Engineering, University of Texas at Austin, Austin, TX, United States. FAU - O'Hair, Matthew AU - O'Hair M AUID- ORCID: 0000-0001-7528-1597 AD - Good Life Games, LLC, Austin, TX, United States. FAU - Tunis, Rachel AU - Tunis R AUID- ORCID: 0000-0001-8362-2005 AD - School of Information, University of Texas at Austin, Austin, TX, United States. FAU - Lee, Grace AU - Lee G AUID- ORCID: 0000-0001-5701-5316 AD - Department of Electrical and Computer Engineering, University of Texas at Austin, Austin, TX, United States. FAU - Rangel, Angelica AU - Rangel A AUID- ORCID: 0009-0002-7473-9556 AD - School of Nursing, The University of Texas at Austin, Austin, TX, United States. FAU - Custer, James AU - Custer J AUID- ORCID: 0000-0001-7196-5297 AD - Department of Population Health, Dell Medical School, The University of Texas at Austin, Austin, TX, United States. FAU - Baranowski, Tom AU - Baranowski T AUID- ORCID: 0000-0002-0653-2222 AD - Children's Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States. FAU - Rathouz, Paul J AU - Rathouz PJ AUID- ORCID: 0000-0001-8380-4300 AD - Department of Population Health, Dell Medical School, The University of Texas at Austin, Austin, TX, United States. FAU - Kim, Miyong T AU - Kim MT AUID- ORCID: 0000-0002-4769-9387 AD - School of Nursing, The University of Texas at Austin, Austin, TX, United States. LA - eng SI - ClinicalTrials.gov/NCT05056129 GR - R01 HL160692/HL/NHLBI NIH HHS/United States PT - Journal Article DEP - 20230510 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC10209796 OTO - NOTNLM OT - digital game OT - heart failure OT - mobile phone OT - older adults OT - self-management COIS- Conflicts of Interest: MO is the owner of Good Life Games, Inc, a company that develops health games for hire, which provided the prototype game images for this study. EDAT- 2023/05/10 12:42 MHDA- 2023/05/10 12:43 PMCR- 2023/05/10 CRDT- 2023/05/10 11:54 PHST- 2023/01/27 00:00 [received] PHST- 2023/03/21 00:00 [accepted] PHST- 2023/03/14 00:00 [revised] PHST- 2023/05/10 12:43 [medline] PHST- 2023/05/10 12:42 [pubmed] PHST- 2023/05/10 11:54 [entrez] PHST- 2023/05/10 00:00 [pmc-release] AID - v12i1e45801 [pii] AID - 10.2196/45801 [doi] PST - epublish SO - JMIR Res Protoc. 2023 May 10;12:e45801. doi: 10.2196/45801.