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NCT04712383 · ClinicalTrials.gov registry record · NA
Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
A NA study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- NA
- Development phase
- 597
- Enrollment target
NCT04712383 is a NA study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 597 participants.
The verdict
NCT04712383, a NA study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- NA
- Development phase
- 597 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the impact of consumer-grade wearable health devices and behavior change support services, including health coaching, on health behaviors, biometrics, and healthcare costs. The study will be a randomized controlled trial with 700 participants who are employees of UMass Memorial Health Care in which 350 participants (control group) receive standard wellness and medical benefits and services for UMass Memorial Health Care employees and in which 350 participants (intervention group) receive these same standard benefits and services as well as the full Fitbit Care product suite (Fitbit wrist-worn device, Fitbit connected weight scale, and Fitbit Premium + Health Coaching service). Participants in the intervention group will be offered support in improving health behaviors that are important to them, including activity, nutrition, sleep, stress management, and medication adherence. They will also be offered support in tying these behaviors to their health goals, including blood pressure management, blood sugar management, cholesterol management, weight loss, smoking cessation, etc. The hypothesis is that those employees in the intervention group will experience improved results compared to those in the control group. It is believed that they will have improved health behaviors, improved biometrics, and lower total healthcare costs (fewer complications, fewer hospitalizations, etc.).
Interventions
- COMBINATION_PRODUCT Fitbit Care intervention arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2022-01-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04712383
The ClinicalTrials.gov registry entry for NCT04712383 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fitbit Care intervention arm is the first listed.
NCT04712383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04712383 about?
NCT04712383 is a clinical study titled "Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs". The purpose of this study is to measure the impact of consumer-grade wearable health devices and behavior change support services, including health coaching, on health behaviors, biometrics, and healthcare costs. The study will be a randomized controlled trial with 700 participants who are employees...
What is the current status of trial NCT04712383?
This trial is currently completed. It is a NA study. The enrollment target is 597 participants. The study started on 2021-01-13. Estimated completion is 2022-01-18.
What interventions are being tested in trial NCT04712383?
The interventions under investigation include: Fitbit Care intervention arm (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04712383?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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