Clinical trial NCT06688903: App-based Diabetes Management and Community-based Interventions
Official title: EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Community-based Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Physical activity as measured by number of steps
timeFrame: 6 months
measure: Physical activity as measured by moderate to vigorous active minutes
timeFrame: 6 months
measure: Physical activity as measured by GPAQ
timeFrame: 6 months
measure: Patient activation score as measured by patient activation measure
timeFrame: 6 months
measure: Medication adherence as measured by MARS-5
timeFrame: 6 months
measure: Quality of life as measured by EQ-5D-5L
timeFrame: 6 months
measure: Healthcare cost as measured by cost of consultations, lab tests, medications, admission
timeFrame: 6 months
measure: Healthcare cost as measured by WPAI
timeFrame: 6 months
measure: Maintenance of the intervention effects on HbA1c
timeFrame: 6 months
measure: Maintenance of the intervention effects on blood pressure
timeFrame: 6 months
measure: Maintenance of the intervention effects on total cholesterol
timeFrame: 6 months
measure: Maintenance of the intervention effects on high-density lipoprotein (HDL)
timeFrame: 6 months
measure: Maintenance of the intervention effects on low-density lipoprotein (LDL)
timeFrame: 6 months
measure: Maintenance of the intervention effects on triglycerides
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References: