EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
Primary Purpose
Diabetes Mellitus, Type 2, Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Nudge, health coaching and shared decision-making
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Nudge, Wearable, Behavioural change
Eligibility Criteria
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 in the coming year at the time of recruitment
- Cognitively impaired (scored ≥ 6 on the Abbreviated Mental Test)
Sites / Locations
- SingHealth Polyclinic (Bedok)Recruiting
- SingHealth Polyclinic (Punggol)Recruiting
- SingHealth Polyclinic (Tampines)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
HbA1c over 9 months
Secondary Outcome Measures
Systolic blood pressure
Systolic blood pressure over 9 months
Physical activity as measured by number of steps
Physical activity over 9 months
Physical activity as measured by moderate to vigorous active minutes
Physical activity over 9 months
Patient activation score as measured by patient activation measure
Difference in patient activation score between intervention and control over 9 months
Medication adherence as measured by Voils Scale
Difference in medication adherence between intervention and control over 9 months
Quality of life as measured by EQ-5D-5L
Difference in quality of life between intervention and control over 9 months
Healthcare cost
Healthcare cost over 9 months
Full Information
NCT ID
NCT05486390
First Posted
August 1, 2022
Last Updated
March 1, 2023
Sponsor
Singapore General Hospital
Collaborators
SingHealth Polyclinics, National University of Singapore, Duke-NUS Graduate Medical School
1. Study Identification
Unique Protocol Identification Number
NCT05486390
Brief Title
EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
Official Title
EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
SingHealth Polyclinics, National University of Singapore, Duke-NUS Graduate Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension
Keywords
Nudge, Wearable, Behavioural change
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Nudge, health coaching and shared decision-making
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
HbA1c over 9 months
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure over 9 months
Time Frame
9 months
Title
Physical activity as measured by number of steps
Description
Physical activity over 9 months
Time Frame
9 months
Title
Physical activity as measured by moderate to vigorous active minutes
Description
Physical activity over 9 months
Time Frame
9 months
Title
Patient activation score as measured by patient activation measure
Description
Difference in patient activation score between intervention and control over 9 months
Time Frame
9 months
Title
Medication adherence as measured by Voils Scale
Description
Difference in medication adherence between intervention and control over 9 months
Time Frame
9 months
Title
Quality of life as measured by EQ-5D-5L
Description
Difference in quality of life between intervention and control over 9 months
Time Frame
9 months
Title
Healthcare cost
Description
Healthcare cost over 9 months
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lian Leng Low
Phone
+6563265872
Email
low.lian.leng@singhealth.com.sg
Facility Information:
Facility Name
SingHealth Polyclinic (Bedok)
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Tan
Email
cynthia.tan.y.l@singhealth.com.sg
Facility Name
SingHealth Polyclinic (Punggol)
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Ling Quah
Email
quah.yan.ling@singhealth.com.sg
Facility Name
SingHealth Polyclinic (Tampines)
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Koot
Email
david.koot@singhealth.com.sg
12. IPD Sharing Statement
Plan to Share IPD
No
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EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
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