EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making

Study Overview
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Brief Summary
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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.

Official Title
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EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Behavioral: Nudge, health coaching and shared decision-making


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21 years old and above Have been diagnosed with diabetes at time of recruitment Most recent glycated haemoglobin (HbA1c) ≥ 7.0% Systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two or more prior visits, physician-diagnosed hypertension, or on antihypertensive medication Physically able to exercise Literate in English Agreeable to be monitored by EMPOWER and/or Fitbit apps Able to conform to 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 next 9 months Cognitively impaired (scored ≥ 6 on the Abbreviated Mental Test)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Nudge, health coaching and shared decision-making<br>* 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 : Goal setting and action plan After-visit summary A report card summarizing the lifestyle behaviour, goals will be made available to facilitate shared decision making.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c over 9 months | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Systolic blood pressure over 9 months | 9 months | 
| Physical activity as measured by number of steps | Physical activity over 9 months | 9 months | 
| Physical activity as measured by moderate to vigorous active minutes | Physical activity over 9 months | 9 months | 
| Patient activation score as measured by patient activation measure | Difference in patient activation score between intervention and control over 9 months | 9 months | 
| Medication adherence as measured by Voils Scale | Difference in medication adherence between intervention and control over 9 months | 9 months | 
| Quality of life as measured by EQ-5D-5L | Difference in quality of life between intervention and control over 9 months | 9 months | 
| Healthcare cost | Healthcare cost over 9 months | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nudge, Wearable, Behavioural change