App-based Diabetes Management and Community-based Interventions

NCT06688903 | Recruiting DMC

• 1 other identifier: 202409-00001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1c over 6 months

  6 months

Secondary Outcomes (14)

• Physical activity as measured by number of steps

  6 months

• Physical activity as measured by moderate to vigorous active minutes

  6 months

• Physical activity as measured by GPAQ

  6 months

• Patient activation score as measured by patient activation measure

  6 months

• Medication adherence as measured by MARS-5

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: App-based diabetes management and community-based health coaching

Interventions

App-based diabetes management and community-based health coaching BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Singapore General Hospital

Singapore, Singapore

NOT YET RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Research coordinators

CONTACT

6562223222; empower@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: January 6, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 25, 2025

Record last verified: 2024-11

Locations

SG (2)