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Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device (EMPOWER)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Nudges
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring wearables, nudges, gamification, behavioural change

Eligibility Criteria

40 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 40 and above at time of recruitment
  • Have been diagnosed with diabetes at time of recruitment
  • Most recent HbA1c more than or equal to 7.0% mmol/l
  • Physically able to exercise
  • Literate in English
  • Agreeable to be monitored by FitBit and adaptive intervention platform
  • Able to conform to the FitBit monitoring schedule

Exclusion Criteria:

  • On 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 more than or equal to 6 on the Abbreviated Mental Test)

Sites / Locations

  • Singapore General Hospital
  • Duke-NUS Medical School
  • National University of Singapore - Saw Swee Hock School of Public Health
  • National University of Singapore - School of Computing
  • SingHealth Polyclinic (Bedok)
  • SingHealth Polyclinic (Punggol)
  • SingHealth Polyclinic (Tampines)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Placebo

Nudges

Arm Description

Patients in control arm will have FitBit. However, there are no personalised nudges given to the patients in the control arm. Occasional reminders to encourage adherence to wearing of the FitBit will be sent.

Patients in the intervention arm will be given a FitBit device and will be encouraged to wear it as often as possible. Using FitBit built-in tracking technologies such as PurePulse and SmartTrack54, patient's daily activities such as number of steps taken, sedentary time, heart rate, sleep time and exercise will be captured and synced to the adaptive intervention platform as developed in Phase 2 for real-time tracking.

Outcomes

Primary Outcome Measures

Patient activation score as measured by patient activation measure
Difference in patient activation score between intervention and control at 12 months

Secondary Outcome Measures

Medication adherence as measured by Voils Scale
Difference in medication adherence between intervention and control at 6 months and 12 months
Medication adherence as measured by Adherence to Refills and Medications Scale
Difference in medication adherence between intervention and control at 6 months and 12 months
Quality of life as measured by SF36-v2
Difference in quality of life between intervention and control at 12 months
Quality of life as measured by EQ-5D-5L
Difference in quality of life between intervention and control at 6 months and 12 months
Healthcare cost
Healthcare cost throughout 12 months
Physical activity as measured by number of steps
Number of steps throughout 12 months
Physical activity as measured by moderate to vigorous active minutes
Moderate to vigorous active minutes throughout 12 months
Diet as measured by calorie intake, carbohydrates and sugar intake
Diet throughout 12 months
HbA1c
HbA1c throughout 12 months

Full Information

First Posted
August 14, 2020
Last Updated
April 11, 2023
Sponsor
Singapore General Hospital
Collaborators
National University of Singapore, SingHealth Polyclinics, Duke-NUS Graduate Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04518566
Brief Title
Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device
Acronym
EMPOWER
Official Title
Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device (EMPOWER)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
National University of Singapore, SingHealth Polyclinics, 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
Data Monitoring Committee
Yes

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. The objective is to design, develop and evaluate an adaptive interventional platform that is capable of delivering personalized behavioral nudges to promote and sustain healthy behavioral changes in senior patients with diabetes. The aim is to assess the clinical effectiveness of real-time personalized educational and behavioral interventions delivered through wearable (FitBit) and an in-integrative mobile application in improving patient activation scores measured using the patient activation measure (PAM). Secondary outcome measures include cost-effectiveness, quality of life, medication adherence, healthcare cost, utilization and lab results. Together with the experts from the SingHealth Regional Health System and National University of Singapore, the investigators will conduct a randomized controlled trial of 1,000 eligible patients. This proposal aims to achieve sustainable and cost-effective behavioral change in diabetes patients through patient-empowerment and targeted chronic disease care.
Detailed Description
Traditional healthcare facility-based consultation model of episodic contact in managing chronic disease patients have limited exposure to monitor and intervene patients' lifestyle factors. These factors have been found to be more effective in managing 3H than medication. The proposed adaptive platform will utilize wearable and mobile application technologies which has the ability to continuous track several physiological and lifestyle factors data (e.g. moderate to vigorous active minutes, resting heart rate, sleep hours and quality and dietary habits) Similarly, due to the limited exposure that healthcare workers have with patients under the current consultation model, current health education and intervention tends to be "one size fits all", passive and "top down" knowledge-loading. Patients are expected to change their behavior or to remember health education knowledge after a consultation session. The proposed adaptive platform will be built using educational and behavioral cues obtained from multiple stakeholders (including patients) and multiple data sources with the aim to gather more comprehensive and targeted feedback that is relevant to patients' needs in their management of their 3H condition. As changes in lifestyle factors and habits takes time, the proposed platform can also provide timely and appropriate feedbacks and reminders to patients at a more constant interval as compared to current model of care when advice was only given during consultation follow-up To be able to add healthy years to the life of the current and future seniors,behavioral interventions that are closely studied and carefully implemented without disruption to the daily activity of the seniors is needed to achieve a revolutionary improvement in current primary care management. The investigators will conduct a qualitative study to have a deep and enriched understanding of the types of nudges that are suited for patients with chronic diseases. Through modelling approach using the electronic medical records, the proposed adaptive platform will profile patients into groups and pre-set the nudges that are suitable for them. This allows the investigators to identify patients that have a higher risk of complications of 3H and quickly match the desired nudges to change behavior. The proposed adaptive platform also aims to empower patients by providing patients with automated bite-sized knowledge of their health conditions. Coupled with real-time personalized feedback to their health behaviors, patients will be equipped with the knowledge to take charge of their health using far lesser healthcare manpower and resources. The proposed adaptive platform will be integrated into common mobile wearable which are readily available devices that are widely used by many Singaporeans now. As such it can also be scaled up relatively easily with minimal resources and education. Therefore, the proposed adaptive intervention will improve health outcomes and reduce healthcare utilization. An empowered patient will result in lesser complications and improve health outcomes, resulting in lower patient and caregiver burden, improving quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
wearables, nudges, gamification, behavioural change

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pragmatic 2-arm (1:1) randomized controlled trial (RCT) on 1,000 eligible diabetes patients using the Pragmatic Explanatory Continuum Indicator Summary Framework-2 (PRECIS-2) criteria for pragmatic trials. Patients with diabetes will be randomly allocated in a 1:1 ratio to either the intervention or control group. The intervention group will receive the personalized feedback intervention through the personalized and adaptive intervention platform app on a FitBit wearable on top of their usual clinical care for their diabetes condition. The control group will receive the FitBit wearable on top of their usual clinical care for their diabetes condition but will not receive the personalized and adaptive intervention platform.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Patients will be screened and recruited for the RCT by research coordinators positioned in the SingHealth polyclinics. They will identify eligible patients according to the inclusion and exclusion criteria. Informed consent will be taken and they will be referred to the research coordinators who will randomly assign the patients to the intervention or control arm using a site-specific pre-generated randomization list. A research coordinator will keep custody of the 3 randomization lists (1 for each recruitment site), and assign treatment accordingly to the intervention listed and not be involved in the recruitment or assessment of patients.
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Patients in control arm will have FitBit. However, there are no personalised nudges given to the patients in the control arm. Occasional reminders to encourage adherence to wearing of the FitBit will be sent.
Arm Title
Nudges
Arm Type
Experimental
Arm Description
Patients in the intervention arm will be given a FitBit device and will be encouraged to wear it as often as possible. Using FitBit built-in tracking technologies such as PurePulse and SmartTrack54, patient's daily activities such as number of steps taken, sedentary time, heart rate, sleep time and exercise will be captured and synced to the adaptive intervention platform as developed in Phase 2 for real-time tracking.
Intervention Type
Behavioral
Intervention Name(s)
Nudges
Intervention Description
Behavioral nudges will be delivered to patients' FitBit device through adaptive intervention platform via notification syncing. To ensure the delivered nudges are timely and personalized, predictive nudges will be developed based on patterns in patients' sociodemographic, clinical and baseline activity tracking. These nudges will be sent automatically to patients upon specific triggers. The nudges will also be assessed for its effectiveness in behavior change. For example, a predictive nudge to encourage patients to take a short walk after detecting long periods of sedentary time will be assessed for its effects by step counts data after delivery of nudge. An iterative approach will be used to generate an effective set of nudges and its most appropriate delivery times for specific activity patterns.
Primary Outcome Measure Information:
Title
Patient activation score as measured by patient activation measure
Description
Difference in patient activation score between intervention and control at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Medication adherence as measured by Voils Scale
Description
Difference in medication adherence between intervention and control at 6 months and 12 months
Time Frame
6 months, 12 months
Title
Medication adherence as measured by Adherence to Refills and Medications Scale
Description
Difference in medication adherence between intervention and control at 6 months and 12 months
Time Frame
6 months, 12 months
Title
Quality of life as measured by SF36-v2
Description
Difference in quality of life between intervention and control at 12 months
Time Frame
12 months
Title
Quality of life as measured by EQ-5D-5L
Description
Difference in quality of life between intervention and control at 6 months and 12 months
Time Frame
6 months, 12 months
Title
Healthcare cost
Description
Healthcare cost throughout 12 months
Time Frame
12 months
Title
Physical activity as measured by number of steps
Description
Number of steps throughout 12 months
Time Frame
12 months
Title
Physical activity as measured by moderate to vigorous active minutes
Description
Moderate to vigorous active minutes throughout 12 months
Time Frame
12 months
Title
Diet as measured by calorie intake, carbohydrates and sugar intake
Description
Diet throughout 12 months
Time Frame
12 months
Title
HbA1c
Description
HbA1c throughout 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 40 and above at time of recruitment Have been diagnosed with diabetes at time of recruitment Most recent HbA1c more than or equal to 7.0% mmol/l Physically able to exercise Literate in English Agreeable to be monitored by FitBit and adaptive intervention platform Able to conform to the FitBit monitoring schedule Exclusion Criteria: On 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 more than or equal to 6 on the Abbreviated Mental Test)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lian Leng Low
Organizational Affiliation
Singhealth Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
486838
Country
Singapore
Facility Name
Duke-NUS Medical School
City
Singapore
Country
Singapore
Facility Name
National University of Singapore - Saw Swee Hock School of Public Health
City
Singapore
Country
Singapore
Facility Name
National University of Singapore - School of Computing
City
Singapore
Country
Singapore
Facility Name
SingHealth Polyclinic (Bedok)
City
Singapore
Country
Singapore
Facility Name
SingHealth Polyclinic (Punggol)
City
Singapore
Country
Singapore
Facility Name
SingHealth Polyclinic (Tampines)
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device

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