- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518566
Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device (EMPOWER)
Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device (EMPOWER)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lian Leng Low
- Phone Number: 91051097
- Email: low.lian.leng@singhealth.com.sg
Study Locations
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Singapore, Singapore, 486838
- Singapore General Hospital
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Singapore, Singapore
- Duke-NUS Medical School
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Singapore, Singapore
- National University of Singapore - Saw Swee Hock School of Public Health
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Singapore, Singapore
- National University of Singapore - School of Computing
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Singapore, Singapore
- SingHealth Polyclinic (Bedok)
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Singapore, Singapore
- SingHealth Polyclinic (Punggol)
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Singapore, Singapore
- SingHealth Polyclinic (Tampines)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Placebo
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.
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Experimental: Nudges
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient activation score as measured by patient activation measure
Time Frame: 12 months
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Difference in patient activation score between intervention and control at 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence as measured by Voils Scale
Time Frame: 6 months, 12 months
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Difference in medication adherence between intervention and control at 6 months and 12 months
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6 months, 12 months
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Medication adherence as measured by Adherence to Refills and Medications Scale
Time Frame: 6 months, 12 months
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Difference in medication adherence between intervention and control at 6 months and 12 months
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6 months, 12 months
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Quality of life as measured by SF36-v2
Time Frame: 12 months
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Difference in quality of life between intervention and control at 12 months
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12 months
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Quality of life as measured by EQ-5D-5L
Time Frame: 6 months, 12 months
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Difference in quality of life between intervention and control at 6 months and 12 months
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6 months, 12 months
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Healthcare cost
Time Frame: 12 months
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Healthcare cost throughout 12 months
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12 months
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Physical activity as measured by number of steps
Time Frame: 12 months
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Number of steps throughout 12 months
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12 months
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Physical activity as measured by moderate to vigorous active minutes
Time Frame: 12 months
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Moderate to vigorous active minutes throughout 12 months
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12 months
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Diet as measured by calorie intake, carbohydrates and sugar intake
Time Frame: 12 months
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Diet throughout 12 months
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12 months
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HbA1c
Time Frame: 12 months
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HbA1c throughout 12 months
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lian Leng Low, Singhealth Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202004-00158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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