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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 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
- •Roll-in Phase
- •Stage C HF (NYHA Class I-III) AND
- •Discharged from a HF hospitalization OR
- •Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
- •Scheduled for appointment in a cardiology clinic with a KCCQ-SS <75
- •Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase
- •Randomized Controlled Trial (beyond roll-in phase)
- •1. Willingness to continue and participate in the study visits and other study activities required for the RCT
排除标准
- •Roll-in Phase
- •Unwilling or unable to provide informed consent for participation in the RCT
- •Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
- •If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
- •History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
- •Age < 18 years
- •Stage D HF (advanced HF under evaluation for LVAD or transplant)
- •NYHA class IV symptoms
- •Congenital heart disease
- •Group 1 pulmonary hypertension
- •Moderate-severe or severe (> 3+) mitral or aortic valvular disease
- •Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
- •Planned surgery within 3 months
- •Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
- •Treating provider or study team physician indicates that participation in the RCT would be unsafe
- •Participation in any ongoing randomized trial that has not completed follow-up
- •Randomized Controlled Trial (beyond roll-in phase)
- •Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device >9 hours/day for at least 1 day.
- •Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
研究组 & 干预措施
Home-based cardiac rehabilitation mobile health intervention
Experimental
Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.
干预措施: HBCR (Other)
Control
No Intervention
Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living.
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
- 6 minute walk distance(The comparison will be at 12-weeks after randomization.)
- 5 meter gait speed(The comparison will be at 12-weeks after randomization.)
- 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.)
- 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.)
- 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.)
研究者
Brian Lindman
Associate Professor
Vanderbilt University Medical Center
研究点 (1)
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