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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Nudge, health coaching and shared decision-making

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • SingHealth Polyclinic (Bedok)
  • Singapore, Singapore
    • SingHealth Polyclinic (Punggol)
  • Singapore, Singapore
    • SingHealth Polyclinic (Tampines)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Nudge, 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 : 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.
No Intervention: Control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Duke-NUS Graduate Medical School; SingHealth Polyclinics; National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Wearable; Nudge; Behavioural change
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Chronic Disease
• Other Study ID Numbers: 202203-00046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No