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NCT06214520Recruiting

App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management

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

Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
525 (estimated)
First submitted
19 Dec 2023
Start date
23 Feb 2024
Primary completion date
30 Oct 2025
Lead sponsor
Singapore General Hospital
NCT number
NCT06214520

What you commit to

  • Study type: Interventional
  • Planned participants: 525
  • From 23 Feb 2024 to the primary completion date, 30 Oct 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have planned major operation or surgical procedure within 9 months from the time of recruitment

Other illness

  • Current participants of ongoing clinical trials involving the usage of a smartphone wearable tracker or mobile health app to assist diabetes management

Other

  • On bolus insulin treatment
  • Require assistance with basic activities of daily living (BADL)
  • Cognitively impaired (scored \< 6 on the Abbreviated Mental Test)
  • Currently pregnant or lactating
  • Past Empower study participants who refused to participate in future Empower studies

Who the study is looking for

  • 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

Age in the registry: 21 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SingHealth Polyclinic (Punggol)
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
SingHealth Polyclinic (Tampines)
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
SingHealth Polyclinic (Sengkang)
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.