App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management (EmpowerPlus)

November 12, 2024 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

525

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention Group
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, videoconferencing platform or telephone call.

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.
Active Comparator: Control 1
Control group 1
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.
No Intervention: Control 2
Control group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 9 months
Difference between HbA1c measured at the in-house laboratory at polyclinics, at baseline and the 9-month mark.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 18 months
Difference between HbA1c measured at the in-house laboratory at polyclinics, at baseline and the 6-month mark. HbA1c will be also retrieved from the Electronic Medical Record over the follow-up period (from month 10 to 18, if any).
18 months
Patient activation score
Time Frame: 9 months
Measured by patient activation measure (PAM), at baseline and the 9-month mark. For each item in PAM, the raw score ranges from 1 (Disagree strongly) to 4 (Agree strongly), and 0 is given to option "Not Applicable", with a higher score indicating a higher level of patient activation.
9 months
Physical activity - steps
Time Frame: 9 months
Measured by the smartphone wearable tracker over 9 months.
9 months
Physical activity - active minutes
Time Frame: 9 months
Measured by the smartphone wearable tracker over 9 months.
9 months
Sleep quality
Time Frame: 9 months
Measured by the smartphone wearable tracker over 9 months.
9 months
Sleep pattern
Time Frame: 9 months
Measured by the smartphone wearable tracker over 9 months.
9 months
Heart rate
Time Frame: 9 months
Measured by the smartphone wearable tracker over 9 months.
9 months
Medication adherence
Time Frame: 9 months
Measured by Voils, at baseline and the 9-month mark. For each item in Voils, the raw score ranges from 1 (missed medication none of the time) to 5 (missed medication every time), with a higher score indicating a poor level of medication adherence (or equivalently a higher level of medication non-adherence).
9 months
Dietary changes
Time Frame: 9 months
Measured with the Empower+ app (calorie intake, carbohydrate and sugar intake) over 9 months.
9 months
Health-related Quality of life
Time Frame: 9 months
Measured by EuroQol-5D-5L (EQ-5D-5L) combined with global health rating on a visual analogue scale (EQ-VAS) at baseline and the 9-month mark. Each dimension in the EQ-5D-5L has five response levels ranging from no problems (Level 1) to extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health). For EQ-VAS, the raw score ranges from 0 to 100, with a higher score indicating a better health that the participant can imagine. The converted index value will be ranging from -0.5 to 1.0, where 0 is the value of a health state equivalent to death, negative values representing values as worse than dead, and 1 is the value of full health.
9 months
Direct healthcare cost
Time Frame: 9 months
Retrieved from the electronic medical records and recorded in survey form: Costs of consultations, lab tests, medications, admissions, at baseline and the 9-month mark.
9 months
Indirect healthcare cost
Time Frame: 9 months
Measured by survey, including self-reported income, travel cost, at baseline and the 9-month mark.
9 months
Indirect healthcare cost
Time Frame: 9 months
Measured by survey - Work Productivity and Activity Impairment (WPAI), at baseline and the 9-month mark. The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). For the last two items, the raw scores range from 0 to 10, with a higher score indicating the patient being more affected by his/her health problems.
9 months
Usability of the Empower+ app and Motivational Interviewing module
Time Frame: 1 month
Measured by the System Usability Scale (SUS), at the 1-month mark (for intervention group and control group 1). For each item in SUS, the raw score ranges from 1 to 5, with a higher score for positive statements and a lower score for negative statements indicating a better usability.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

SingHealth Polyclinic - Sengkang
SingHealth Polyclinic - Punggol
SingHealth Polyclinic - Tampines
Tiong Bahru Community Health Centre

Investigators

  • Principal Investigator: Lian Leng Low, Singhealth Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202304-00020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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