Diabetes Mellitus Type 2EmpowerPlusNCT06214520
App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management
A study testing App-based Motivational Interviewing & Human health coaching and Empower+ App & Smartwatch wearable tracker in people with Diabetes Mellitus Type 2, run by Singapore General Hospital at 3 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- App-based Motivational Interviewing & Human health coaching and Empower+ App & Smartwatch wearable tracker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 3 sitesSingapore
- Study dates
- 23 Feb 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore3 sites, 3 recruiting
- Recruiting
SingHealth Polyclinic (Punggol)
Singapore
Yan Ling Quah, quah.yan.ling@singhealth.com.sg
- Recruiting
SingHealth Polyclinic (Sengkang)
Singapore
Wei Mei Jeremy Koh, jeremy.koh.w.m@singhealth.com.sg
- Recruiting
SingHealth Polyclinic (Tampines)
Singapore
David Koot, david.koot@singhealth.com.sg
About this study
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
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
- Being tested
- App-based Motivational Interviewing & Human health coaching, Empower+ App & Smartwatch wearable tracker
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based Motivational Interviewing & Human health coachingBehavioural
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.
Empower+ App & Smartwatch wearable trackerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Group Receives: Behavioral: App-based Motivational Interviewing & Human health coaching; Behavioral: Empower+ App & Smartwatch wearable tracker |
| Control 1 | Active comparator | Control group 1 Receives: Behavioral: Empower+ App & Smartwatch wearable tracker |
| Control 2 | No intervention | Control group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Difference between HbA1c measured at the in-house laboratory at polyclinics, at baseline and the 9-month mark.
Measured: 9 months
Secondary outcomes (14)
HbA1c
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).
Measured: 18 months
Patient activation score
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.
Measured: 9 months
Physical activity - steps
Measured by the smartphone wearable tracker over 9 months.
Measured: 9 months
Physical activity - active minutes
Measured by the smartphone wearable tracker over 9 months.
Measured: 9 months
Sleep quality
Measured by the smartphone wearable tracker over 9 months.
Measured: 9 months
Sleep pattern
Measured by the smartphone wearable tracker over 9 months.
Measured: 9 months
Heart rate
Measured by the smartphone wearable tracker over 9 months.
Measured: 9 months
Medication adherence
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).
Measured: 9 months
Dietary changes
Measured with the Empower+ app (calorie intake, carbohydrate and sugar intake) over 9 months.
Measured: 9 months
Health-related Quality of life
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.
Measured: 9 months
Direct healthcare cost
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.
Measured: 9 months
Indirect healthcare cost
Measured by survey, including self-reported income, travel cost, at baseline and the 9-month mark.
Measured: 9 months
Indirect healthcare cost
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.
Measured: 9 months
Usability of the Empower+ app and Motivational Interviewing module
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start23 Feb 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 525 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SingHealth Polyclinic - Sengkang, SingHealth Polyclinic - Punggol, SingHealth Polyclinic - Tampines, Tiong Bahru Community Health Centre
- Responsible party
- Sponsor
- Investigators
- Lian Leng Low, Principal investigator, Singhealth Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214520
- Sponsor's protocol ID
- 202304-00020
- Acronym
- EmpowerPlus
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06214520
- Acronym / sponsor ID
- EmpowerPlus / 202304-00020
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 525 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- SingHealth Polyclinic - Sengkang, SingHealth Polyclinic - Punggol, SingHealth Polyclinic - Tampines, Tiong Bahru Community Health Centre
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: App-based Motivational Interviewing & Human health coaching, Behavioral: Empower+ App & Smartwatch wearable trackerIntervention Group |
| Control 1 | Active comparator | Behavioral: Empower+ App & Smartwatch wearable trackerControl group 1 |
| Control 2 | No intervention | –Control group 2 |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based Motivational Interviewing & Human health coachingPatients 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. | Behavioural | Intervention |
| Empower+ App & Smartwatch wearable trackerPatients 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. | Behavioural | Control 1, Intervention |
Primary outcome
HbA1c
Time frame: 9 months
Difference between HbA1c measured at the in-house laboratory at polyclinics, at baseline and the 9-month mark.
14 secondary outcomes
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
Indirect healthcare cost
Time frame: 9 months
Usability of the Empower+ app and Motivational Interviewing module
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lian Leng Low principal investigator
Singhealth Foundation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based Motivational Interviewing & Human health coaching and Empower+ App & Smartwatch wearable tracker in people with Diabetes Mellitus Type 2, run by Singapore General Hospital at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lian Leng Low (63265872, low.lian.leng@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024; AzTrials last refreshed its copy on 1 Nov 2026.