Skip to main content
Clinical Trials/NCT04712383
NCT04712383
Completed
Not Applicable

Impact of Wearable Health Devices and Health and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs

University of Massachusetts, Worcester1 site in 1 country597 target enrollmentJanuary 13, 2021
ConditionsHealth Behavior

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Behavior
Sponsor
University of Massachusetts, Worcester
Enrollment
597
Locations
1
Primary Endpoint
Change in total medical expenditures for calendar year 2020 to 2021
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.).

Registry
clinicaltrials.gov
Start Date
January 13, 2021
End Date
January 18, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Steven Bird

Professor

University of Massachusetts, Worcester

Eligibility Criteria

Inclusion Criteria

  • Employed by UMassMemorial Health Care
  • Receive benefits from UMassMemorial Health Care
  • Have a smartphone

Exclusion Criteria

  • Unable to consent
  • Non-English speaking

Outcomes

Primary Outcomes

Change in total medical expenditures for calendar year 2020 to 2021

Time Frame: 12 months

Change in total medical expenditures from calendar year 2020 to 2021 Participant insurance claim information will be analyzed to determine the change in total medical expenditures from 2020 to 2021 and the results will be compared between the intervention and control groups.

Changes in Biometric Outcomes

Time Frame: 12 months

Participants will have biometric screenings including hemoglobin A1c at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.

Changes in self-reported health behaviors and levels of motivation and confidence in making improvements

Time Frame: 3 months, 6 months, 9 months, and 12 months

Participants will complete a health behavior survey (addresses overall health, nutrition, activity, sleep, mindfulness, alcohol, and smoking behaviors as well as levels of motivation and confidence in making improvements) at the beginning of the study and every three months until the end of the study. This will be used to determine changes in behaviors, motivation, and confidence over the course of the study, and the results will be compared between the intervention and control groups. This is not done via a scale, but answers range from Strongly agree, to Somewhat agree, to Neither agree nor disagree, to Somewhat disagree, to Strongly disagree.

Secondary Outcomes

  • Correlations between engagement with health coach and total medical expenditure and biometric outcomes(12 months)
  • Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes(12 months)
  • Proportion of participants achieving target biometric outcomes(12 months)
  • Proportion of participants achieving categorical improvement in biometric outcomes(12 months)
  • Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes(12 months)
  • Changes in metrics collected by Fitbit devices and Fitbit app(weekly and totaled over 12 months)

Study Sites (1)

Loading locations...

Similar Trials