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App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management

Study acronym: EmpowerPlus
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 14, 2024 (before its estimated October 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Eligibility criteria expanded, about 4 wordsv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2024 to Feb 23, 2024
    • Site details revised at 3 of 3 sites
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06214520
Lead Sponsor Singapore General Hospital
Collaborators: SingHealth Polyclinic - Sengkang, SingHealth Polyclinic - Punggol, SingHealth Polyclinic - Tampines, Tiong Bahru Community Health Centre
Conditions
(from sponsor)
Diabetes Mellitus Type 2
Related terms Diabetes Mellitus, Type 2
Enrollment 525 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov