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Clinical Trials/NCT06688903
NCT06688903
Recruiting
Not Applicable

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

Singapore General Hospital1 site in 1 country150 target enrollmentJanuary 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
Singapore General Hospital
Enrollment
150
Locations
1
Primary Endpoint
HbA1c
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2024
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

HbA1c

Time Frame: 6 months

HbA1c over 6 months

Secondary Outcomes

  • 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)
  • Quality of life as measured by EQ-5D-5L(6 months)
  • Healthcare cost as measured by cost of consultations, lab tests, medications, admission(6 months)
  • Healthcare cost as measured by WPAI(6 months)
  • Maintenance of the intervention effects on HbA1c(6 months)
  • Maintenance of the intervention effects on blood pressure(6 months)
  • Maintenance of the intervention effects on total cholesterol(6 months)
  • Maintenance of the intervention effects on high-density lipoprotein (HDL)(6 months)
  • Maintenance of the intervention effects on low-density lipoprotein (LDL)(6 months)
  • Maintenance of the intervention effects on triglycerides(6 months)

Study Sites (1)

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