PMID- 35284389 OWN - NLM STAT- MEDLINE DCOM- 20220428 LR - 20220428 IS - 2296-2565 (Electronic) IS - 2296-2565 (Linking) VI - 10 DP - 2022 TI - EMPOWERing Patients With Diabetes Using Profiling and Targeted Feedbacks Delivered Through Smartphone App and Wearable (EMPOWER): Protocol for a Randomized Controlled Trial on Effectiveness and Implementation. PG - 805856 LID - 10.3389/fpubh.2022.805856 [doi] LID - 805856 AB - INTRODUCTION: Type 2 diabetes mellitus (T2DM) poses huge burden and cost on the healthcare system. Mobile health (mHealth) interventions that incorporate wearables may be able to improve diabetes self-management. The aim of this randomized controlled trial (RCT) is to investigate the clinical and cost-effectiveness of personalized educational and behavioral interventions delivered through an EMPOWER mobile application (app) among patients with T2DM. METHODS: This is a parallel two-arm randomized controlled trial (RCT). Patients with T2DM recruited from primary care will be randomly allocated in a 1:1 ratio to either intervention or control group. The intervention group will receive personalized educational and behavioral interventions through the EMPOWER app in addition to their usual clinical care. The control group will receive the usual clinical care for their T2DM but will not have access to the EMPOWER app. Our primary outcome is patient activation score at 12 months. Secondary outcomes will include HbA1c, physical activity level and diet throughout 12 months; quality of life (QoL), medication adherence, direct healthcare cost and indirect healthcare cost at 6 and 12 months. DISCUSSION: This RCT will provide valuable insights into the effectiveness and implementation of personalized educational and behavioral interventions delivered through mobile application in T2DM management. Findings from this study can help to achieve sustainable and cost-effective behavioral change in patients with T2DM, and this can be potentially scaled to other chronic diseases such as hypertension and dyslipidemia. CI - Copyright (c) 2022 Kwan, Yoon, Tan, Tai, Tan, Phang, Tan, Tan, Quah, Koot, Teo and Low. FAU - Kwan, Yu Heng AU - Kwan YH AD - Department of Pharmacy, National University of Singapore, Singapore, Singapore. AD - Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore. AD - SingHealth Internal Medicine Residency Programme, Singapore, Singapore. FAU - Yoon, Sungwon AU - Yoon S AD - Program in Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore. AD - Centre for Population Health Research and Implementation, SingHealth Regional Health System, SingHealth, Singapore, Singapore. FAU - Tan, Chuen Seng AU - Tan CS AD - Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, Singapore, Singapore. AD - Yong Loo Lin School of Medicine National University of Singapore, National University Health System, Singapore, Singapore. FAU - Tai, Bee Choo AU - Tai BC AD - Saw Swee Hock School of Public Health, National University of Singapore, National University Health System, Singapore, Singapore. AD - Yong Loo Lin School of Medicine National University of Singapore, National University Health System, Singapore, Singapore. FAU - Tan, Wee Boon AU - Tan WB AD - Population Health and Integrated Care Office, Singapore General Hospital, Singapore, Singapore. FAU - Phang, Jie Kie AU - Phang JK AD - Centre for Population Health Research and Implementation, SingHealth Regional Health System, SingHealth, Singapore, Singapore. FAU - Tan, Ngiap Chuan AU - Tan NC AD - SingHealth Polyclinics, Singapore, Singapore. AD - SingHealth Duke-NUS Family Medicine Academic Clinical Program, Duke-NUS Medical School, Singapore, Singapore. FAU - Tan, Cynthia Yan Ling AU - Tan CYL AD - SingHealth Polyclinics, Singapore, Singapore. FAU - Quah, Yan Ling AU - Quah YL AD - SingHealth Polyclinics, Singapore, Singapore. FAU - Koot, David AU - Koot D AD - SingHealth Polyclinics, Singapore, Singapore. FAU - Teo, Hock Hai AU - Teo HH AD - School of Computing, National University of Singapore, Singapore, Singapore. FAU - Low, Lian Leng AU - Low LL AD - Centre for Population Health Research and Implementation, SingHealth Regional Health System, SingHealth, Singapore, Singapore. AD - Population Health and Integrated Care Office, Singapore General Hospital, Singapore, Singapore. AD - SingHealth Duke-NUS Family Medicine Academic Clinical Program, Duke-NUS Medical School, Singapore, Singapore. AD - SingHealth Community Hospital, Singapore, Singapore. AD - Department of Family Medicine and Continuing Care, Singapore General Hospital, Singapore, Singapore. LA - eng PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220225 PL - Switzerland TA - Front Public Health JT - Frontiers in public health JID - 101616579 SB - IM MH - *Diabetes Mellitus, Type 2/therapy MH - Feedback MH - Humans MH - *Mobile Applications MH - Power, Psychological MH - Randomized Controlled Trials as Topic MH - *Wearable Electronic Devices PMC - PMC8913889 OTO - NOTNLM OT - diabetes OT - nudge OT - protocol OT - randomized controlled trial OT - smartphone application COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/03/15 06:00 MHDA- 2022/04/29 06:00 PMCR- 2022/02/25 CRDT- 2022/03/14 05:59 PHST- 2021/10/31 00:00 [received] PHST- 2022/02/02 00:00 [accepted] PHST- 2022/03/14 05:59 [entrez] PHST- 2022/03/15 06:00 [pubmed] PHST- 2022/04/29 06:00 [medline] PHST- 2022/02/25 00:00 [pmc-release] AID - 10.3389/fpubh.2022.805856 [doi] PST - epublish SO - Front Public Health. 2022 Feb 25;10:805856. doi: 10.3389/fpubh.2022.805856. eCollection 2022.