Actively Recruiting

Phase Not Applicable
Age: 21Years - 100Years
All Genders
NCT06214520

App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management

Led by Singapore General Hospital · Updated on 2024-11-14

525

Participants Needed

3

Research Sites

122 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

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.

CONDITIONS

Official Title

App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management

Who Can Participate

Age: 21Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 21 years and above
  • Diagnosed with type 2 diabetes mellitus (T2DM)
  • 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 the Empower+ app, use the smartwatch tracker, and follow the monitoring schedule
Not Eligible

You will not qualify if you...

  • On bolus insulin treatment
  • Require help with basic daily activities
  • Planned major operation or 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 using a smartphone wearable or health app for diabetes
  • Previously participated in Empower study but refused future participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

L

Lian Leng Low

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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