NCT06479876招募中不适用
Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Average daily total activity counts
研究概览
简要总结
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessments performed at baseline visit and final (12-week visit) will be performed by a study team member unaware of randomization group. Clinical outcomes upon completion study will be assessed by an adjudicator who is blinded to randomization group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Average daily total activity counts
时间窗: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.
Daily total activity counts are determined by a triaxial actigraphy device.
次要结局
- Average daily active minutes(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.)
- Average daily steps(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.)
- Average daily energy expenditure(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.)
- Average daily moderate to vigorous active minutes(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.)
- Sustained physical activity bursts of 10 minutes or greater per day(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.)
- 6 minute walk distance(The comparison will be at 12-weeks after randomization.)
- Chair sit to stand time(The comparison will be at 12-weeks after randomization.)
- 5 meter gait speed(The comparison will be at 12-weeks after randomization.)
- Balance test(The comparison will be at 12-weeks after randomization.)
- AM-PAC Basic Mobility Outpatient Short Form (Low Function)(The comparison will be at 12-weeks after randomization.)
- Short Physical Performance Battery Score(The comparison will be at 12-weeks after randomization.)
- Heart-failure specific health status assessed by the KCCQ(The comparison will be at 12-weeks after randomization.)
- Physical health status assessed by the PROMIS 10(The comparison will be at 12-weeks after randomization.)
- Mental health status assessed by the PROMIS 10(The comparison will be at 12-weeks after randomization.)
- Mood disturbance assessed by PHQ9(The comparison will be at 12-weeks after randomization.)
- Blood pressure(The comparison will be at 12-weeks after randomization.)
- Behavioral Regulation In Exercise Questionnaire 3(The comparison will be at 12-weeks after randomization.)
- Social support and exercise survey(The comparison will be at 12-weeks after randomization.)
- Multidimensional Self-Efficacy for Exercise Scale(The comparison will be at 12-weeks after randomization.)
- General self-efficacy scale(The comparison will be at 12-weeks after randomization.)
- Modified Heart Failure Collaborative GDMT score(The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less.)
- Probability of the hierarchical clinical event composite(Over the entire available follow-up period for randomized participants (minimum of 12 weeks).)
- All-cause unplanned rehospitalization(Over the entire available follow-up period for randomized participants (minimum of 12 weeks).)
- Worsening heart failure event(Over the entire available follow-up period for randomized participants (minimum of 12 weeks).)
- All-cause mortality(Over the entire available follow-up period for randomized participants (minimum of 12 weeks).)
- "Thriving patient" composite(The comparison will be made at 12 weeks.)
- 6 minute walk distance(The comparison will be at 12-weeks after randomization.)
- Mood disturbance assessed by PHQ9(The comparison will be at 12-weeks after randomization.)
- Behavioral Regulation In Exercise Questionnaire 3(The comparison will be at 12-weeks after randomization.)
- Social support and exercise survey(The comparison will be at 12-weeks after randomization.)
- Multidimensional Self-Efficacy for Exercise Scale(The comparison will be at 12-weeks after randomization.)
- General self-efficacy scale(The comparison will be at 12-weeks after randomization.)
- Blood pressure(The comparison will be at 12-weeks after randomization.)
- Modified Heart Failure Collaborative GDMT score(The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less.)
- Probability of the hierarchical clinical event composite(Over the entire available follow-up period for randomized participants (minimum of 12 weeks).)
- Worsening heart failure event(Over the entire available follow-up period for randomized participants (minimum of 12 weeks).)
- All-cause mortality(Over the entire available follow-up period for randomized participants (minimum of 12 weeks).)
- "Thriving patient" composite(The comparison will be made at 12 weeks.)
- Average daily active minutes(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.)
- Average daily steps(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.)
- Average daily energy expenditure(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.)
- Average daily moderate to vigorous active minutes(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.)
- Sustained physical activity bursts of 10 minutes or greater per day(The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.)
- Chair sit to stand time(The comparison will be at 12-weeks after randomization.)
- 5 meter gait speed(The comparison will be at 12-weeks after randomization.)
- Balance test(The comparison will be at 12-weeks after randomization.)
- AM-PAC Basic Mobility Outpatient Short Form (Low Function)(The comparison will be at 12-weeks after randomization.)
- Short Physical Performance Battery Score(The comparison will be at 12-weeks after randomization.)
- Heart-failure specific health status assessed by the KCCQ(The comparison will be at 12-weeks after randomization.)
- Physical health status assessed by the PROMIS 10(The comparison will be at 12-weeks after randomization.)
- Mental health status assessed by the PROMIS 10(The comparison will be at 12-weeks after randomization.)
研究者
Brian Lindman
Associate Professor
Vanderbilt University Medical Center
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve InterventionsValvular Heart DiseaseNCT06077201Vanderbilt University Medical Center240
已完成
不适用
Home versus Hospital based cardiac rehabilitation: a randomised trial with preference arms to compare clinical outcomes and costs. Cornwall Heart Attack Rehabilitation Management Study (CHARMS).Circulatory SystemAcute myocardial infarctionISRCTN52215857Peninsula Medical School (Primary Care) (UK)230
已完成
不适用
Cardiac rehabilitation and self efficacyCardiac rehabilitation.IRCT201106086747N1Tabriz University of Medical Sciences80
已完成
不适用
Effects of cardiac rehabilitation in the management of fatigue in patients with Coronary Heart DiseaseCORONARY HEART DISEASE.Chronic Ischaemic Heart DiseaseI20-I25IRCT2014081618520N1Vice Chancellor for research of Shahid Beheshti University of Medical Sciences50
尚未招募
1 期
Effect of Home-based Cardiac Rehabilitation on Health Outcomes among patients with Heart FailureCTRI/2023/11/060276Sheeja Sebastian