Actively Recruiting
EMPOWERing Patients with Type 2 Diabetes Mellitus in Primary Care Through App-based Motivational Interviewing PLUS AI-Powered Diabetes Management: Randomised Controlled Trial
Led by Singapore General Hospital · Updated on 2024-11-14
525
Participants Needed
3
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Singapore General Hospital
Lead Sponsor
S
SingHealth Polyclinic - Sengkang
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to managing type 2 diabetes mellitus (T2DM) by combining app-based motivational interviewing (MI) with artificial intelligence (AI) powered personalized nudges through a mobile application called EMPOWER-PLUS. This study is a randomized controlled trial (RCT) designed to improve glycemic control and reduce complications in patients with poorly controlled T2DM. The goal is to assess the effectiveness and implementation of this digital health intervention compared to usual care. The trial has three groups: the intervention group receives the EMPOWER-PLUS app with AI-powered nudges, app-based MI through virtual health coaching, and a smartwatch wearable device to track physical activity and health data. The first control group receives usual care plus the smartwatch and nudges but without MI. The second control group receives usual care alone without access to the app, nudges, or smartwatch. Participants in the intervention group will be encouraged to wear the smartwatch for at least 10 hours daily to monitor steps, heart rate, sleep, and exercise. Health coaching is provided virtually via the app, videoconferencing, or phone. Participants will be monitored over 36 weeks with the primary outcome being the change in HbA1c levels, a key measure of blood sugar control. Secondary outcomes include medication adherence, diet, physical activity, quality of life, sleep quality, heart rate, healthcare costs, and app usability. The study involves regular data collection through the smartwatch and app, questionnaires, and clinical assessments. The total participation duration covers 9 months, with ongoing evaluation of both clinical and behavioral outcomes to better understand the impact of this digital diabetes management approach.
CONDITIONS
Brief Title
App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 21 years and above
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Recent HbA1c result of 7.5% or higher within the past 3 months
- Physically able to exercise
- Able to read and converse in English
- Able to download and use the Empower+ app and smartwatch wearable device, and comply with monitoring requirements
You will not qualify if you...
- On bolus insulin treatment
- Require assistance with basic activities of daily living
- Planned major surgery within 9 months from recruitment
- Cognitively impaired (score less than 6 on Abbreviated Mental Test)
- Currently pregnant or breastfeeding
- Participating in other clinical trials involving smartphone wearable trackers or mobile health apps for diabetes
- Previous Empower study participants who declined future participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 9 months
Participants use the Empower+ app along with a smartwatch wearable device to track daily activities including steps, heart rate, sleep, and exercise. Health coaching is provided virtually either one-on-one or in groups through the app, videoconferencing, or telephone calls.
Regular virtual coaching sessions and continuous app usage
Trial Site Locations
Total: 3 locations
1
SingHealth Polyclinic (Punggol)
Singapore, Singapore
Actively Recruiting
2
SingHealth Polyclinic (Sengkang)
Singapore, Singapore
Actively Recruiting
3
SingHealth Polyclinic (Tampines)
Singapore, Singapore
Actively Recruiting
Research Team
L
Lian Leng Low
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here