App-based Diabetes Management and Community-based Interventions

EMPOWERing Patients with Chronic Diseases Through Smartphone App, Health Coaching and Community-based Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Behavioral: App-based diabetes management and community-based health coaching

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research coordinators; Phone Number: 6562223222; Email: empower@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore General Hospital
    • Contact: Research coordinators; Phone Number: 6562223222; Email: empower@singhealth.com.sg
    • Contact: Lian Leng Low, Masters
  • Singapore, Singapore
    • Not yet recruiting
    • Singapore General Hospital
    • Contact: Lian Leng Low; Phone Number: 91051097; Email: low.lian.leng@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: App-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c over 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity as measured by number of steps	Physical activity over 6 months	6 months
Physical activity as measured by moderate to vigorous active minutes	Physical activity over 6 months	6 months
Patient activation score as measured by patient activation measure	Difference in patient activation score between intervention and control over 6 months	6 months
Quality of life as measured by EQ-5D-5L	Difference in quality of life between intervention and control over 6 months	6 months
Healthcare cost as measured by cost of consultations, lab tests, medications, admission	Healthcare cost over 6 months	6 months
Healthcare cost as measured by WPAI	Healthcare cost over 6 months	6 months
Physical activity as measured by GPAQ	Physical activity as measured by GPAQ	6 months
Medication adherence as measured by MARS-5	Difference in medication adherence between intervention and control over 6 months	6 months
Maintenance of the intervention effects on HbA1c	HbA1c over 6 months after the 6-month intervention	6 months
Maintenance of the intervention effects on blood pressure	Blood pressure over 6 months after the 6-month intervention	6 months
Maintenance of the intervention effects on total cholesterol	Total cholesterol over 6 months after the 6-month intervention	6 months
Maintenance of the intervention effects on high-density lipoprotein (HDL)	HDL over 6 months after the 6-month intervention	6 months
Maintenance of the intervention effects on low-density lipoprotein (LDL)	LDL over 6 months after the 6-month intervention	6 months
Maintenance of the intervention effects on triglycerides	Triglycerides over 6 months after the 6-month intervention	6 months

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 202409-00001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No