App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: App-based Motivational Interviewing & Human health coaching, Empower+ App & Smartwatch wearable tracker.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Type 2. Basic parameters: 21 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Behavioral App-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, - Behavioral Empower+ 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.
Primary outcome measures
- HbA1c [Time frame: 9 months]
Secondary outcome measures (12)
- HbA1c [Time frame: 18 months]
- Patient activation score [Time frame: 9 months]
- Physical activity - steps [Time frame: 9 months]
- Physical activity - active minutes [Time frame: 9 months]
- Sleep quality [Time frame: 9 months]
- Sleep pattern [Time frame: 9 months]
- Heart rate [Time frame: 9 months]
- Medication adherence [Time frame: 9 months]
- Dietary changes [Time frame: 9 months]
- Health-related Quality of life [Time frame: 9 months]
- Direct healthcare cost [Time frame: 9 months]
- Indirect healthcare cost [Time frame: 9 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Singapore · 3 centers
- SingHealth Polyclinic (Punggol) — Singapore
- SingHealth Polyclinic (Sengkang) — Singapore
- SingHealth Polyclinic (Tampines) — Singapore
Identifiers
NCT: NCT06214520 · 202304-00020