Behavioral Economics and Mobility After Stroke (BE Mobile) (BE Mobile)
2021年9月15日 更新者：University of Pennsylvania
Using Behavioral Economics to Improve Mobility for Adults With Stroke
In this pilot, randomized controlled trial, the investigators will compare the preliminary effectiveness of a gamification with social incentives 8 week intervention to increase physical activity for adults with stroke.
研究概览
详细说明
In this 2 arm randomized trial, the investigators will compare the preliminary effectiveness of a social incentive-based gamification intervention to increase physical activity relative to a control arm among adults with stroke.
All participants will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above their baseline and then participate in an 8 week intervention.
The gamification arm will be entered into a game with points and levels designed using insights from behavioral economics.
They will be asked to select a social support partner who will receive weekly updates on their progress in the game.
研究类型
介入性
注册 (实际的)
34
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
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- History of ischemic or hemorrhagic stroke (confirmed with ICD-10 or DRG code) at least 3 months prior to enrollment
- Ability to provide informed consent
- Life Space Assessment mobility level 3
- Ability to ambulate outside of their home (self-reported)
- Owns a smartphone or tablet compatible with required applications for the wearable tracking device
- Sufficient cognitive ability to participate (5-minute Montreal Cognitive Assessment Score ≥ 11 points)
Exclusion Criteria:
- Inability to provide informed consent, illiteracy or inability to speak, read, and write English
- Self-reported history of falls within the last 3 months
- Severe cognitive impairment (MoCA score ≤ 10 points)
- Medical condition that may limit participation in physical activity program (e.g. metastatic cancer, end-stage renal disease)
- Currently institutionalized in skilled nursing or long-term care facility
- Baseline step count > 7500/day
- Currently receiving physical therapy services
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control arm
Participants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period.
Participants will complete study surveys at baseline and the end of the 8 week intervention.
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实验性的：Gamification arm
Participants will wear the Fitbit device and record their daily step counts during the baseline and 8 week intervention period.
Participants will have a weekly step goal they are encouraged to meet.
Participants will engage in a social incentive-based gamification based on points and levels that leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains.
Participants will receive daily feedback for the step counts and weekly feedback for levels.
Participants will be asked to identify a support partner, who will receive weekly reports with the the participant's points and levels balance.
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Participants will select a step goal that is 33%, 40%, or 50% above their baseline step value.
Participants in this group will participate in a game with points and levels to help motivate participants to meet their daily step goal.
Additionally, all participants will identify a support partner to receive weekly updates on their performance and offer positive encouragement to help the participant meet their step goal.
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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 |
|---|---|---|
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Daily step counts
大体时间：Intervention weeks 1-8
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Change in mean daily steps from baseline
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Intervention weeks 1-8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Daily step counts
大体时间：Intervention weeks 1-8
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Proportion of days participants in the gamification arm met their daily step goal
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Intervention weeks 1-8
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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
- 研究主任：Kimberly J Waddell, PhD, MS、University of Pennsylvania
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2020年11月16日
初级完成 (实际的)
2021年7月12日
研究完成 (实际的)
2021年7月12日
研究注册日期
首次提交
2020年10月22日
首先提交符合 QC 标准的
2020年10月22日
首次发布 (实际的)
2020年10月29日
研究记录更新
最后更新发布 (实际的)
2021年9月16日
上次提交的符合 QC 标准的更新
2021年9月15日
最后验证
2021年9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.