Empowering patients with comorbid diabetes and hypertension through a multi-component intervention of mobile app, health coaching and shared decision-making: Protocol for an effectiveness-implementation of randomised controlled trial

• Published in: PloS one Vol. 19; no. 2; p. e0296338
• Main Authors: Kwan, Yu Heng, Yoon, Sungwon, Tai, Bee Choo, Tan, Chuen Seng, Phang, Jie Kie, Tan, Wee Boon, Tan, Ngiap Chuan, Tan, Cynthia Yan Ling, Koot, David, Quah, Yan Ling, Teo, Hock Hai, Low, Lian Leng
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 26-02-2024; Public Library of Science (PLoS)
• Subjects: Biology and life sciences; Comorbidity; Complications and side effects; Computer and Information Sciences; Decision-making; Diabetes; Diabetes Mellitus - epidemiology; Diabetes Mellitus - therapy; Diabetes therapy; Diagnosis; Exercise; Glycosylated hemoglobin; Humans; Hypertension; Hypertension - complications; Hypertension - epidemiology; Hypertension - therapy; Medical care, Cost of; Medicine and Health Sciences; Mentoring; Mobile Applications; Patient compliance; Power, Psychological; Randomized Controlled Trials as Topic; Research and Analysis Methods; Risk factors; Social Sciences; Study Protocol; Type 2 diabetes; Singapore
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0296338

Diabetes and hypertension are prevalent and costly to the health system. We have developed a mobile app (EMPOWER app) which enables remote monitoring and education through personalised nudges. We aim to study the effectiveness of a multi-component intervention comprising the EMPOWER mobile app with health coaching and shared decision-making for diabetes and hypertension.
We will conduct a two-arm, open-label, pragmatic randomised controlled trial (RCT). Participants with comorbid diabetes and hypertension enrolled from public primary care clinics will be randomised to either intervention or control in a 1:1 ratio. The intervention group participants will have access to health coaching with shared decision-making interventions in addition to the EMPOWER app and their usual primary care. The control group participants will continue to receive usual primary care and will neither receive the EMPOWER app nor health coaching and shared decision-making interventions. Our primary outcome is change in HbA1c level over 9 months. Secondary outcomes include change in systolic blood pressure, quality of life, patient activation, medication adherence, physical activity level, diet, and healthcare cost (direct and indirect) over 9 months.
Our trial will provide key insights into clinical- and cost-effectiveness of a multi-component intervention comprising EMPOWER mobile app, health coaching and shared decision-making in diabetes and hypertension management. This trial will also offer evidence on cost-effective and sustainable methods for promoting behavioural changes among patients with comorbid diabetes and hypertension.
This study was registered on clintrials.gov on August 3, 2022, with the trial registration number: NCT05486390.