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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
SingHealth Polyclinic (Punggol)
RECRUITING
Singapore
SingHealth Polyclinic (Sengkang)
RECRUITING
Singapore
SingHealth Polyclinic (Tampines)
RECRUITING
Singapore
Contact Information
Primary
Lian Leng Low
low.lian.leng@singhealth.com.sg
63265872
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 525
Treatments
Experimental: Intervention
Intervention Group
Active_comparator: Control 1
Control group 1
No_intervention: Control 2
Control group 2
Related Therapeutic Areas
Sponsors
Leads: Singapore General Hospital
Collaborators: Tiong Bahru Community Health Centre, SingHealth Polyclinic - Tampines, SingHealth Polyclinic - Sengkang, SingHealth Polyclinic - Punggol

This content was sourced from clinicaltrials.gov