Diabetes Mellitus Type 2
Conditions
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.
Interventions
BEHAVIORALApp-based diabetes management and community-based health coaching
All participants will use the EMPOWER+ app and a Fitbit wearable. They will also received community-based health coaching and/or other prescribed structured programmes.
Sponsors
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months | HbA1c over 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Physical activity as measured by number of steps | 6 months | Physical activity 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 |
| Healthcare cost as measured by WPAI | 6 months | Healthcare cost over 6 months |
Countries
Singapore
Contacts
Primary ContactResearch coordinators
Outcome results
None listed