Clinical trial NCT06214520: App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: SingHealth Polyclinic - Sengkang
name: SingHealth Polyclinic - Punggol
name: SingHealth Polyclinic - Tampines
name: Tiong Bahru Community Health Centre
First posted: 2024-01-19
Enrollment: 525
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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 \&lt; 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

Primary outcomes:
measure: HbA1c
timeFrame: 9 months
Secondary outcomes:
measure: HbA1c
timeFrame: 18 months
measure: Patient activation score
timeFrame: 9 months
measure: Physical activity - steps
timeFrame: 9 months
measure: Physical activity - active minutes
timeFrame: 9 months
measure: Sleep quality
timeFrame: 9 months
measure: Sleep pattern
timeFrame: 9 months
measure: Heart rate
timeFrame: 9 months
measure: Medication adherence
timeFrame: 9 months
measure: Dietary changes
timeFrame: 9 months
measure: Health-related Quality of life
timeFrame: 9 months
measure: Direct healthcare cost
timeFrame: 9 months
measure: Indirect healthcare cost
timeFrame: 9 months
measure: Indirect healthcare cost
timeFrame: 9 months
measure: Usability of the Empower+ app and Motivational Interviewing module
timeFrame: 1 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: SingHealth Polyclinic (Punggol)
city: Singapore
country: Singapore
facility: SingHealth Polyclinic (Sengkang)
city: Singapore
country: Singapore
facility: SingHealth Polyclinic (Tampines)
Study officials:
affiliation: Singhealth Foundation
name: Lian Leng Low
role: PRINCIPAL_INVESTIGATOR
References: