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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05486390
• Other study ID #: 202203-00046
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: May 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus, Type 2
• Hypertension

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.

Locations

Country	Name	City	State
Singapore	SingHealth Polyclinic (Bedok)	Singapore
Singapore	SingHealth Polyclinic (Punggol)	Singapore
Singapore	SingHealth Polyclinic (Tampines)	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
Singapore General Hospital	Duke-NUS Graduate Medical School, National University of Singapore, SingHealth Polyclinics

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	HbA1c over 9 months	9 months
Secondary	Systolic blood pressure	Systolic blood pressure over 9 months	9 months
Secondary	Physical activity as measured by number of steps	Physical activity over 9 months	9 months
Secondary	Physical activity as measured by moderate to vigorous active minutes	Physical activity over 9 months	9 months
Secondary	Patient activation score as measured by patient activation measure	Difference in patient activation score between intervention and control over 9 months	9 months
Secondary	Medication adherence as measured by Voils Scale	Difference in medication adherence between intervention and control over 9 months	9 months
Secondary	Quality of life as measured by EQ-5D-5L	Difference in quality of life between intervention and control over 9 months	9 months
Secondary	Healthcare cost	Healthcare cost over 9 months	9 months