RecruitingNot ApplicableNCT06214520

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


Sponsor

Singapore General Hospital

Enrollment

525 participants

Start Date

Feb 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a smartphone app called Empower+ that uses motivational interviewing (a counseling technique to help people make healthy changes) and artificial intelligence to help people with type 2 diabetes better manage their blood sugar. Participants will use the app along with a smartwatch fitness tracker to encourage healthier behaviors. **You may be eligible if...** - You are 21 or older - You have been diagnosed with type 2 diabetes - Your most recent HbA1c (a 3-month blood sugar average) was 7.5% or higher in the past 3 months - You are physically able to exercise - You can read and speak English - You can download and use a smartphone app and wearable fitness tracker **You may NOT be eligible if...** - You are on bolus (rapid-acting mealtime) insulin - You need help with basic daily activities (washing, dressing, etc.) - You have a major surgery planned within the next 9 months - You are cognitively impaired - You are currently pregnant or breastfeeding - You are already in another clinical trial using a wearable tracker or health app for diabetes - You previously participated in the Empower study and declined future participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALApp-based Motivational Interviewing & Human health coaching

Patients in the intervention arm will be given a smartwatch wearable device and will be encouraged to wear it for at least 10 hours per day. Patient's daily activities such as number of steps taken, sedentary time, heart rate, sleep time and exercise will be captured and synced to the EMPOWER+ app for real-time tracking. App-based Motivational Interviewing \& Human health coaching: The health coach will conduct 1:1 or group-based health coaching as appropriate virtually over the EMPOWER+ app, videoconferencing platform or telephone call.

BEHAVIORALEmpower+ App & Smartwatch wearable tracker

Patients in the intervention arm will be given a smartwatch wearable device and will be encouraged to wear it for at least 10 hours per day. Patient's daily activities such as number of steps taken, sedentary time, heart rate, sleep time and exercise will be captured and synced to the EMPOWER+ app for real-time tracking.


Locations(3)

SingHealth Polyclinic (Punggol)

Singapore, Singapore

SingHealth Polyclinic (Sengkang)

Singapore, Singapore

SingHealth Polyclinic (Tampines)

Singapore, Singapore

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NCT06214520


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