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Clinical Trials/NCT06214520
NCT06214520
Recruiting
Not Applicable

EMPOWERing Patients with Type 2 Diabetes Mellitus (T2DM) in Primary Care Through App-based Motivational Interviewing PLUS Artificial Intelligence Powered Diabetes Management (EMPOWER-PLUS): Randomised Controlled Trial

Singapore General Hospital3 sites in 1 country525 target enrollmentFebruary 23, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
Singapore General Hospital
Enrollment
525
Locations
3
Primary Endpoint
HbA1c
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

There is an urgent need for better control and prevention of complications in type 2 diabetes mellitus (T2DM). Behavioural change is critical, and while literature suggests that motivational interviewing (MI) may be effective in improving glycemic control, none has explored app-based MI designed specifically for T2DM. The overall objective of this project is to determine the effectiveness of primary care model combining app-based MI and AI-powered personalised nudges delivered through a mobile application (app) for diabetes management (EMPOWER-PLUS). The project aims to evaluate the effectiveness and implementation of MI and nudges through EMPOWERPLUS to deliver diabetes management through a randomised controlled trial (RCT). This will be a 3-arm RCT with primary outcome measure being the difference in HbA1c level at week 36 between the intervention and control arms. Secondary outcome measures include cost-effectiveness, quality of life, medication adherence, diet, and physical activity. Eligible poorly controlled T2DM patients with T2DM in polyclinics will be randomized to intervention arm who will receive EMPOWER-PLUS and smartwatch wearable on top of their usual clinical care. The first control group will have access to nudges delivered through app and smartwatch wearable in addition to usual clinical care but will not receive MI. The second control group will receive usual care (no access to MI, nudges and smartwatch wearable). This study is important to improve T2DM outcomes and reduce healthcare utilization by providing scientifically evaluated and transformative primary care model. Leveraging on digital technology and artificial intelligence to drive personalised care, behavioural change and empowerment has huge potential for scale up.

Registry
clinicaltrials.gov
Start Date
February 23, 2024
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 21 years and above
  • Have been diagnosed with diabetes (T2DM)
  • Had HbA1c result of ≥ 7.5% within past 3 months
  • Physically able to exercise
  • Able to read and converse in English
  • Able to download the Empower+ app, use the smartphone wearable tracker, and conform to the minimum smartwatch and app monitoring schedule

Exclusion Criteria

  • On bolus insulin treatment
  • Require assistance with basic activities of daily living (BADL)
  • Have planned major operation or surgical procedure within 9 months from the time of recruitment
  • Cognitively impaired (scored \< 6 on the Abbreviated Mental Test)
  • Currently pregnant or lactating
  • Current participants of ongoing clinical trials involving the usage of a smartphone wearable tracker or mobile health app to assist diabetes management
  • Past Empower study participants who refused to participate in future Empower studies

Outcomes

Primary Outcomes

HbA1c

Time Frame: 9 months

Difference between HbA1c measured at the in-house laboratory at polyclinics, at baseline and the 9-month mark.

Secondary Outcomes

  • Physical activity - active minutes(9 months)
  • Medication adherence(9 months)
  • Physical activity - steps(9 months)
  • HbA1c(18 months)
  • Patient activation score(9 months)
  • Sleep pattern(9 months)
  • Heart rate(9 months)
  • Sleep quality(9 months)
  • Direct healthcare cost(9 months)
  • Indirect healthcare cost(9 months)
  • Dietary changes(9 months)
  • Health-related Quality of life(9 months)
  • Usability of the Empower+ app and Motivational Interviewing module(1 month)

Study Sites (3)

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