Diabetes Mellitus, Type 2, Hypertension
Conditions
Keywords
Nudge, Wearable, Behavioural change
Brief summary
Chronic diseases are the leading cause of deaths in Singapore. The rising prevalence in chronic diseases with age and Singapore's rapidly aging population calls for new models of care to effectively prevent the onset and delay the progression of these diseases. Advancement in medical technology has offered new innovations that aid healthcare systems in coping with the rapid rising in healthcare needs. These include mobile applications, wearable technologies and machine learning-derived personalized behaviorial interventions. The overall goal of the project is to improve health outcomes in chronic disease patients through delivering targeted nudges via mobile application and wearable to sustain behavioral change. Our overall objective is to design, develop, and evaluate an adaptive intervention platform on wearable devices and shared decision-making during consultations for patients with diabetes and hypertension. Our aim for this study is to assess the clinical effectiveness of real-time personalized educational and behavioural interventions delivered through wearable (Fitbit) and an integrative mobile application in improving patient glycaemic control measured using HbA1c over 9 months. Secondary outcomes will include change in systolic blood pressure, quality of life (QoL), patient activation, medication adherence, physical activity level, diet, direct healthcare cost and indirect healthcare cost over 9 months. We will conduct a randomized controlled trial among patients with comorbid diabetes and hypertension. This proposal aims to develop sustainable and cost-effective behavioural change among patients with comorbid diabetes and hypertension through patient empowerment and targeted chronic disease care.
Interventions
BEHAVIORALNudge, health coaching and shared decision-making
The EMPOWER app aims to nudge the participant towards successful self-management of their diabetes condition by encouraging and reinforcing positive lifestyle behaviors in 3 main aspects - diet, physical activity, medication adherence. Notifications included content based on behavioural change technique including feedback on performance, positive reinforcement, and prompts to self-monitor. Each notification focused on a single behaviour (physical activity, medication adherence or diet). The participants in the intervention group will also interact with health coach throughout the study duration. In this study, the health coach will be responsible for the following roles : 1. Goal setting and action plan 2. After-visit summary A report card summarizing the lifestyle behaviour, goals will be made available to facilitate shared decision making.
Sponsors
SingHealth Polyclinics
National University of Singapore
Duke-NUS Graduate Medical School
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 21 years old and above 2. Have been diagnosed with diabetes at time of recruitment 3. Most recent glycated haemoglobin (HbA1c) ≥ 7.0% 4. Systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two or more prior visits, physician-diagnosed hypertension, or on antihypertensive medication 5. Physically able to exercise 6. Literate in English 7. Agreeable to be monitored by EMPOWER and/or Fitbit apps 8. Able to conform to monitoring schedule
Exclusion criteria
1. On bolus insulin treatment 2. Require assistance with basic activities of daily living (BADL) 3. Have planned major operation or surgical procedure within next 9 months 4. Cognitively impaired (scored ≥ 6 on the Abbreviated Mental Test)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 9 months | HbA1c over 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity as measured by number of steps | 9 months | Physical activity over 9 months |
| Physical activity as measured by moderate to vigorous active minutes | 9 months | Physical activity over 9 months |
| Patient activation score as measured by patient activation measure | 9 months | Difference in patient activation score between intervention and control over 9 months |
| Systolic blood pressure | 9 months | Systolic blood pressure over 9 months |
| Quality of life as measured by EQ-5D-5L | 9 months | Difference in quality of life between intervention and control over 9 months |
| Healthcare cost | 9 months | Healthcare cost over 9 months |
| Medication adherence as measured by Voils Scale | 9 months | Difference in medication adherence between intervention and control over 9 months |
Countries
Singapore
Outcome results
None listed