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Recruiting NCT06688903

App-based Diabetes Management and Community-based Interventions

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: App-based diabetes management and community-based health coaching.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • HbA1c [Time frame: 6 months]
Secondary outcome measures (12)
  • Physical activity as measured by number of steps [Time frame: 6 months]
  • Physical activity as measured by moderate to vigorous active minutes [Time frame: 6 months]
  • Physical activity as measured by GPAQ [Time frame: 6 months]
  • Patient activation score as measured by patient activation measure [Time frame: 6 months]
  • Medication adherence as measured by MARS-5 [Time frame: 6 months]
  • Quality of life as measured by EQ-5D-5L [Time frame: 6 months]
  • Healthcare cost as measured by cost of consultations, lab tests, medications, admission [Time frame: 6 months]
  • Healthcare cost as measured by WPAI [Time frame: 6 months]
  • Maintenance of the intervention effects on HbA1c [Time frame: 6 months]
  • Maintenance of the intervention effects on blood pressure [Time frame: 6 months]
  • Maintenance of the intervention effects on total cholesterol [Time frame: 6 months]
  • Maintenance of the intervention effects on high-density lipoprotein (HDL) [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Singapore · 2 centers
  • Singapore General Hospital — Singapore
  • Singapore General Hospital — Singapore

Identifiers

NCT: NCT06688903 · 202409-00001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗