Clinical trial NCT04712383: Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
Official title: Impact of Wearable Health Devices and Health and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: health behavior
fitness
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Fitbit LLC
name: Massachusetts eHealth Initiative
First posted: 2021-01-15
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant
* Unable to consent
* Non-English speaking

Primary outcomes:
measure: Change in total medical expenditures for calendar year 2020 to 2021
timeFrame: 12 months
measure: Changes in Biometric Outcomes
timeFrame: 12 months
measure: Changes in Biometric Outcomes
timeFrame: 12 months
measure: Changes in Biometric Outcomes
timeFrame: 12 months
measure: Changes in Biometric Outcomes
timeFrame: 12 months
measure: Changes in Biometric Outcomes
timeFrame: 12 months
measure: Changes in Biometric Outcomes
timeFrame: 12 months
measure: Changes in self-reported health behaviors and levels of motivation and confidence in making improvements
timeFrame: 3 months, 6 months, 9 months, and 12 months
Secondary outcomes:
measure: Proportion of participants achieving target biometric outcomes
timeFrame: 12 months
measure: Proportion of participants achieving categorical improvement in biometric outcomes
timeFrame: 12 months
measure: Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes
timeFrame: 12 months
measure: Changes in metrics collected by Fitbit devices and Fitbit app
timeFrame: weekly and totaled over 12 months
measure: Changes in metrics collected by Fitbit devices and Fitbit app
timeFrame: weekly and totaled over 12 months
measure: Changes in metrics collected by Fitbit devices and Fitbit app
timeFrame: weekly and totaled over 12 months
measure: Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes
timeFrame: 12 months
measure: Correlations between engagement with health coach and total medical expenditure and biometric outcomes
timeFrame: 12 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMassMemorial Health Care
state: Massachusetts
Study officials:
affiliation: UMass Memorial Healthcare
name: Steven Bird, MD
role: PRINCIPAL_INVESTIGATOR
References: