App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management

NCT06214520 | Recruiting

• 1 other identifier: 202304-00020
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Difference between HbA1c measured at the in-house laboratory at polyclinics, at baseline and the 9-month mark.

  9 months

Secondary Outcomes (14)

• HbA1c

  18 months

• Patient activation score

  9 months

• Physical activity - steps

  9 months

• Physical activity - active minutes

  9 months

• Sleep quality

  9 months

Study Arms (3)

Intervention

EXPERIMENTAL

Intervention Group

Behavioral: App-based Motivational Interviewing & Human health coaching; Behavioral: Empower+ App & Smartwatch wearable tracker

Control 1

ACTIVE COMPARATOR

Control group 1

Behavioral: Empower+ App & Smartwatch wearable tracker

Control 2

NO INTERVENTION

Control group 2

Interventions

App-based Motivational Interviewing & Human health coaching BEHAVIORAL

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.

Intervention

Empower+ App & Smartwatch wearable tracker BEHAVIORAL

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.

Control 1; Intervention

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• SingHealth Polyclinic - Sengkang: collaborator
• SingHealth Polyclinic - Punggol: collaborator
• SingHealth Polyclinic - Tampines: collaborator
• Tiong Bahru Community Health Centre: collaborator

Study Sites (3)

SingHealth Polyclinic (Punggol)

Singapore, Singapore

RECRUITING

SingHealth Polyclinic (Sengkang)

Singapore, Singapore

RECRUITING

SingHealth Polyclinic (Tampines)

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lian Leng Low

  Singhealth Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Leng Low

CONTACT

63265872; low.lian.leng@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 19, 2024
• Study Start: February 23, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

SG (3)