App-based Diabetes Management and Community-based Interventions
- Conditions
- Diabetes Mellitus Type 2
- Registration Number
- NCT06688903
- Lead Sponsor
- Singapore General Hospital
- Brief Summary
Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Aged 21 years and above
- Having been diagnosed with type 2 diabetes mellitus
- Having most recent HbA1c ≥ 6.5%
- Physically able to exercise
- Able to read, write, and converse in English
- Able to comply with study procedures
- Requiring assistance with basic activities of daily living (BADL)
- Have planned major operation or surgical procedure within 6 months from the time of recruitment
- Current pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method HbA1c 6 months HbA1c over 6 months
- Secondary Outcome Measures
Name Time Method Physical activity as measured by number of steps 6 months Physical activity over 6 months
Physical activity as measured by moderate to vigorous active minutes 6 months Physical activity over 6 months
Physical activity as measured by GPAQ 6 months Physical activity as measured by GPAQ
Patient activation score as measured by patient activation measure 6 months Difference in patient activation score between intervention and control over 6 months
Medication adherence as measured by MARS-5 6 months Difference in medication adherence between intervention and control over 6 months
Quality of life as measured by EQ-5D-5L 6 months Difference in quality of life between intervention and control over 6 months
Healthcare cost as measured by cost of consultations, lab tests, medications, admission 6 months Healthcare cost over 6 months
Healthcare cost as measured by WPAI 6 months Healthcare cost over 6 months
Maintenance of the intervention effects on HbA1c 6 months HbA1c over 6 months after the 6-month intervention
Maintenance of the intervention effects on blood pressure 6 months Blood pressure over 6 months after the 6-month intervention
Maintenance of the intervention effects on total cholesterol 6 months Total cholesterol over 6 months after the 6-month intervention
Maintenance of the intervention effects on high-density lipoprotein (HDL) 6 months HDL over 6 months after the 6-month intervention
Maintenance of the intervention effects on low-density lipoprotein (LDL) 6 months LDL over 6 months after the 6-month intervention
Maintenance of the intervention effects on triglycerides 6 months Triglycerides over 6 months after the 6-month intervention
Trial Locations
- Locations (1)
Singapore General Hospital
🇸🇬Singapore, Singapore