Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
2022年2月18日 更新者：Steven Bird、University of Massachusetts, Worcester
Impact of Wearable Health Devices and Health 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 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.).
研究概览
研究类型
介入性
注册 (实际的)
597
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
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Worcester、Massachusetts、美国、01655-0002
- UMassMemorial Health Care
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Fitbit Care intervention arm
The experimental arm will receive the full Fitbit Care product suite (Fitbit wrist-worn device, Fitbit connected weight scale, and Fitbit Premium + Health Coaching service).
Participants in the experimental arm will also be offered support in improving health behaviors that are important to them, including activity, nutrition, sleep, stress management, and medication adherence.
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Entire suite of Fitbit Care.
|
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无干预：Fitbit study control arm
Participants in the control arm will have access to standard healthcare benefits available to all employees, but will not have access to any of the Fitbit Care interventions
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in total medical expenditures for calendar year 2020 to 2021
大体时间：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.
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12 months
|
|
Changes in Biometric Outcomes
大体时间：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.
|
12 months
|
|
Changes in Biometric Outcomes
大体时间：12 months
|
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
|
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Changes in Biometric Outcomes
大体时间：12 months
|
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.
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12 months
|
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Changes in Biometric Outcomes
大体时间：12 months
|
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
|
|
Changes in Biometric Outcomes
大体时间：12 months
|
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
|
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Changes in Biometric Outcomes
大体时间：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.
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12 months
|
|
Changes in self-reported health behaviors and levels of motivation and confidence in making improvements
大体时间：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.
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3 months, 6 months, 9 months, and 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of participants achieving target biometric outcomes
大体时间：12 months
|
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.
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12 months
|
|
Proportion of participants achieving categorical improvement in biometric outcomes
大体时间：12 months
|
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
|
|
Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes
大体时间：12 months
|
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
|
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Changes in metrics collected by Fitbit devices and Fitbit app
大体时间：weekly and totaled over 12 months
|
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.
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weekly and totaled over 12 months
|
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Changes in metrics collected by Fitbit devices and Fitbit app
大体时间：weekly and totaled over 12 months
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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.
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weekly and totaled over 12 months
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Changes in metrics collected by Fitbit devices and Fitbit app
大体时间：weekly and totaled over 12 months
|
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.
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weekly and totaled over 12 months
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Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes
大体时间：12 months
|
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
|
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Correlations between engagement with health coach and total medical expenditure and biometric outcomes
大体时间：12 months
|
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.
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12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Steven Bird, MD、UMass Memorial Healthcare
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月13日
初级完成 (实际的)
2022年1月18日
研究完成 (实际的)
2022年1月18日
研究注册日期
首次提交
2021年1月11日
首先提交符合 QC 标准的
2021年1月13日
首次发布 (实际的)
2021年1月15日
研究记录更新
最后更新发布 (实际的)
2022年2月21日
上次提交的符合 QC 标准的更新
2022年2月18日
最后验证
2022年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.