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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712383
• Other study ID #: H00021669
• Secondary ID: 2020 - MeHI - 01
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: January 18, 2022

Study information

• Verified date: February 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Combination Product:
• Fitbit Care intervention arm
Entire suite of Fitbit Care.

Locations

Country	Name	City	State
United States	UMassMemorial Health Care	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Fitbit Inc, Massachusetts eHealth Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total medical expenditures for calendar year 2020 to 2021	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.	12 months
Primary	Changes in Biometric Outcomes	Participants will have biometric screening including body weight 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.	12 months
Primary	Changes in Biometric Outcomes	Participants will have biometric screenings including waist circumference 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.	12 months
Primary	Changes in Biometric Outcomes	Participants will have biometric screenings including blood pressure 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.	12 months
Primary	Changes in Biometric Outcomes	Participants will have biometric screenings including LDL cholesteral 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.	12 months
Primary	Changes in Biometric Outcomes	Participants will have biometric screenings including HDL cholesteral 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.	12 months
Primary	Changes in Biometric Outcomes	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.	12 months
Primary	Changes in self-reported health behaviors and levels of motivation and confidence in making improvements	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.	3 months, 6 months, 9 months, and 12 months
Secondary	Proportion of participants achieving target biometric outcomes	Participants will have biometric screenings (including body weight, waist circumference, blood pressure, hemoglobin A1c, and LDL and HDL cholesterol) at the beginning and end of the study that will be used to determine, for each biometric, the percentage of participants in each study arm who reach standard clinical target values, and the percentage of participants will be compared between the intervention and control groups.	12 months
Secondary	Proportion of participants achieving categorical improvement in biometric outcomes	Participants will have biometric screenings (including body weight, waist circumference, blood pressure, hemoglobin A1c, and LDL and HDL cholesterol) at the beginning and end of the study that will be used to determine, for each biometric, the percentage of participants in each study arm who improve at least one clinical category (for example, from stage 2 hypertension to stage 1 hypertension, and the percentage of participants will be compared between the intervention and control groups.	12 months
Secondary	Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes	Participant responses to the health behavior survey (behaviors as well as levels of motivation and confidence in making improvements) will be analyzed for correlations with changes in total medical expenditures and biometric outcomes.	12 months
Secondary	Changes in metrics collected by Fitbit devices and Fitbit app	For participants in the intervention group, changes in steps taking collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.	weekly and totaled over 12 months
Secondary	Changes in metrics collected by Fitbit devices and Fitbit app	For participants in the intervention group, changes in active zone minutes collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.	weekly and totaled over 12 months
Secondary	Changes in metrics collected by Fitbit devices and Fitbit app	For participants in the intervention group, changes in hours of sleep collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.	weekly and totaled over 12 months
Secondary	Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes	For participants in the intervention group, changes in metrics collected by Fitbit devices and in the Fitbit app will be analyzed for correlations with changes in total medical expenditures and biometric outcomes.	12 months
Secondary	Correlations between engagement with health coach and total medical expenditure and biometric outcomes	For participants in the intervention group, engagement with the health coach in the Fitbit app will be measured based on the number of text messages and interactions with the health coaching action plan and analyzed for correlations with changes in total medical expenditures and biometric outcomes.	12 months