Impact of Wearable Health Devices and Health and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 597
- 试验地点
- 2
- 主要终点
- Change in total medical expenditures for calendar year 2020 to 2021
研究概览
简要总结
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.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Employed by UMassMemorial Health Care
- •Receive benefits from UMassMemorial Health Care
- •Have a smartphone
排除标准
- •Unable to consent
- •Non-English speaking
结局指标
主要结局
Change in total medical expenditures for calendar year 2020 to 2021
时间窗: 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 self-reported health behaviors and levels of motivation and confidence in making improvements
时间窗: 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.
Changes in Biometric Outcomes
时间窗: 12 months
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.
次要结局
- 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)
研究者
Steven Bird
Professor
University of Massachusetts, Worcester