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

Not Applicable

Active, not recruiting

• Conditions: Hypertension; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Nudge, health coaching and shared decision-making

• Registration Number: NCT05486390
• Lead Sponsor: Singapore General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-03
• Study Start: 2023-02-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-08
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Nudge, health coaching and shared decision-making	-

Primary Outcome Measures

Name	Time	Method
HbA1c	9 months	HbA1c over 9 months

Secondary Outcome Measures

Name	Time	Method
Physical activity as measured by number of steps	9 months	Physical activity over 9 months
Medication adherence as measured by Voils Scale	9 months	Difference in medication adherence between intervention and control 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
Systolic blood pressure	9 months	Systolic blood pressure over 9 months
Healthcare cost	9 months	Healthcare cost 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

Trial Locations

Locations (3)

SingHealth Polyclinic (Bedok); 🇸🇬 Singapore, Singapore

SingHealth Polyclinic (Punggol); 🇸🇬 Singapore, Singapore

SingHealth Polyclinic (Tampines); 🇸🇬 Singapore, Singapore