Diabetes Mellitus Type 2
Conditions
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.
Interventions
BEHAVIORALApp-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.
BEHAVIORALEmpower+ 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.
Sponsors
SingHealth Polyclinic - Sengkang
SingHealth Polyclinic - Punggol
SingHealth Polyclinic - Tampines
Tiong Bahru Community Health Centre
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 9 months | Difference between HbA1c measured at the in-house laboratory at polyclinics, at baseline and the 9-month mark. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient activation score | 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. |
| Physical activity - steps | 9 months | Measured by the smartphone wearable tracker over 9 months. |
| Physical activity - active minutes | 9 months | Measured by the smartphone wearable tracker over 9 months. |
| Sleep quality | 9 months | Measured by the smartphone wearable tracker over 9 months. |
| Sleep pattern | 9 months | Measured by the smartphone wearable tracker over 9 months. |
| Heart rate | 9 months | Measured by the smartphone wearable tracker over 9 months. |
| HbA1c | 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). |
| Dietary changes | 9 months | Measured with the Empower+ app (calorie intake, carbohydrate and sugar intake) over 9 months. |
| Health-related Quality of life | 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. |
| Direct healthcare cost | 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. |
| Indirect healthcare cost | 9 months | Measured by survey, including self-reported income, travel cost, at baseline and the 9-month mark. |
| Usability of the Empower+ app and Motivational Interviewing module | 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. |
| Medication adherence | 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). |
Countries
Singapore
Contacts
Primary ContactLian Leng Low
Outcome results
None listed