GAME HFpEF（射血分数保留的心力衰竭）
游戏化和社会激励的随机对照试验，以提高射血分数保留的心力衰竭患者对体育活动的坚持
This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. There will be a 2-week run-in period to obtain baseline measures of physical activity, followed by a 6-month intervention period and then a 3-month follow-up period.
研究概览
地位
详细说明
Heart failure (HF) with preserved ejection fraction (HFpEF), a syndrome characterized by exercise intolerance due to breathlessness and fatigue, is a major public health problem rising in prevalence. No pharmacologic strategy has been shown to consistently improve functional capacity of HFpEF patients, though exercise training is beneficial. However, reimbursement barriers and access limitations preclude widespread implementation of cardiac rehabilitation. Despite the association between increased physical activity, lower HF hospitalization, and improved quality of life, physical activity levels remain dismally low in HF patients. This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. There will be a 2-week run-in period to obtain baseline measures of physical activity, followed by a 6-month intervention period and then a 3-month follow-up period. All participants will be asked to use the wearable device during the day every day during the intervention and follow-up periods. The three interventions by study arm will vary as follows: Control, Gamification plus social incentive which includes; Pre commitment, support partner, a game using; points, levels, fresh starts, trophies and automated coaching. Competition arm which includes; Pre commitment, a game using; points, levels, fresh starts, trophies and automated coaching and a competition with other participants and access to the leadership board.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Chinyere Anucha
- 邮箱：chinyere.anucha@pennmedicine.upenn.edu
研究联系人备份
- 姓名：Samantha Coratti
- 电话号码：215-746-4372
- 邮箱：samantha.coratti@pennmedicine.upenn.edu
学习地点
-
-
Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- 招聘中
- The University of Pennsylvania
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首席研究员：
- Alexander Fanaroff, MD, MHS
-
接触：
- Samantha Coratti
- 邮箱：samantha.coratti@pennmedicine.upenn.edu
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Adults (age ≥ 18 years) who: 1) have a diagnosis of heart failure with preserved ejection; 2) have an ejection fraction ≥ 50%; 3) meet ONE of the following criteria: any history of hospitalization with a primary diagnosis of heart failure with preserved ejection fraction, BNP > 75 pg/mL (> 225 pg/mL in patients with atrial fibrillation), H2FPEF score ≥ 5, OR elevated pulmonary capillary wedge pressure on right heart catheterization (≥ 15 mm Hg at rest or ≥ 25 mm Hg with exercise); 4) own a smartphone or tablet capable of connecting to the internet; 5) are able to read English; 6) are able to provide informed consent
Exclusion Criteria:
Participants will be excluded if they are currently participating in another interventional physical activity study, have medical conditions prohibiting ambulation without assistance (including use of an assistive device other than a cane) or participation in an exercise program, if a 9-month physical activity program is infeasible or unsafe, upcoming cardiovascular procedures (e.g. stent or surgery) or if the patient is at a high level of physical activity (>7500 steps per day) or very low level of physical activity (< 1000 steps/day) at baseline. Patients taking > 7500 steps/day will be excluded based on data showing that increasing step count beyond 7500 steps/day does not improve outcomes in all-comer populations, and to ensure that we are recruiting a population of patients with symptomatic HF. Patients taking < 1000 steps/day at baseline will be excluded to ensure that we will not enroll very frail patients with a need for more intensive exercise training or physical therapy. To ensure that we are capturing patients who are limited in their exertional capacity by heart failure, we will also exclude patients with dementia, end-stage renal disease on dialysis, cirrhosis, cardiac surgery or transcatheter valve replacement within the last year, severe aortic stenosis or severe mitral stenosis.
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control
In addition to using a wearable device, participants in the control arm will receive a daily notification of their step count from the previous day. |
|
|
实验性的：Gamification plus social incentive
Participants will receive daily text messages on whether or not they hit their step goal. Participants will be entered into a game, that runs for 6 months. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. They will receive twice-weekly motivational or educational text messages that highlight the effect of exercise on functional capacity in patients with HFpEF. Participants will select a family member or friend who will serve as a support partner. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. The support partner will receive a weekly email reminding him/her of these approaches and updating him/her on the participant's progress including accumulated points, level in the game, and average step count. |
Participants in the Gamification plus social incentive intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail. |
|
实验性的：Gamification plus competition
Participants will receive daily text messages on whether or not they hit their step goal. Participants will be entered into a game, that runs for 6 months. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. They will receive twice-weekly motivational or educational text messages that highlight the effect of exercise on functional capacity in patients with HFpEF. Participants will have access to a leaderboard that will include two other participants. Participants will be ranked on the leaderboard by total points over the course of the study. They will receive a weekly text message with their position on the leaderboard. |
Participants in the Gamification plus competition intervention arm will receive gamification and a competition as part of the intervention. See arm descriptions for more detail. |
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 |
|---|---|---|
|
The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period.
大体时间：9 months
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The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period. |
9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in mean daily steps from baseline to through the 6-month intervention period
大体时间：6 months
|
Change in mean daily steps from baseline to through the 6-month intervention period |
6 months
|
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Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 6-month intervention period
大体时间：6 months
|
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 6-month intervention period |
6 months
|
|
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 3-month post-intervention follow-up period
大体时间：9 months
|
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 3-month post-intervention follow-up period |
9 months
|
|
Change in six-minute walk distance from baseline through the 6-month intervention period
大体时间：6 months
|
Change in six-minute walk distance from baseline through the 6-month intervention period |
6 months
|
|
Change in six-minute walk distance from baseline through the 3-month post-intervention follow-up period
大体时间：9 months
|
Change in six-minute walk distance from baseline through the 3-month post-intervention follow-up period |
9 months
|
合作者和调查者
调查人员
- 首席研究员：Alexander Fanaroff, MD, MHS、University of Pennsylvania
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 855906
- 1R01HL174691 (美国 NIH 拨款/合同)
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研究美国 FDA 监管的设备产品
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