REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Change in 6-minute Walking Distance (6MWD)
研究概览
简要总结
RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.
详细描述
The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age ≥65) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.
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
partial mask (outcomes assessor)
入排标准
- 年龄范围
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks.
- •Capable of self-consent.
- •Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).
排除标准
- •Non-ambulatory.
- •Moderate or severe cognitive impairment.
- •Unable/unwilling to consent.
- •PCI-related groin hematoma that precludes brisk walking.
- •Incarcerated.
- •Unable to use mHealth software in English or Spanish.
- •Severe osteoarthritis, or joint replacement within last 3 months.
- •Parkinson's disease or other progressive movement disorder.
- •Regular use of walker for ambulation.
- •Projected life expectancy <3 months.
- •Clinical judgment concerning other safety or nonadherence issues.
- •Participants admitted from long-term care facility.
- •Currently listed for heart transplant.
- •Left ventricular assist device recipient.
- •Completion of ambulatory cardiac rehabilitation program within prior 3 months.
研究组 & 干预措施
mHealth-CR
Participants in this arm will receive the mHealth-CR intervention.
干预措施: mHealth-CR (Other)
Usual Care
Participants in this arm receive usual care.
结局指标
主要结局
Change in 6-minute Walking Distance (6MWD)
时间窗: Baseline, 3 months
Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6-minute walk test (6MWT) is a submaximal exercise test in which the pace is self-selected by the participant. The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse. The outcome change in 6MWD is calculated as 3 month 6MWD minus baseline 6MWD.
Number of Participants in Each Engagement Phenotype on Intervention Arm
时间窗: 3 months
Weekly engagement will be measured as the fraction of the following 11 elements completed each week: (1-7) daily entry of exercise data and relative perceived exertion (RPE); (8) completed weekly phone call with exercise therapist; (9) at least one electronic communication with exercise therapist; (10) watching educational video (which will vary by week); and (11) at least one home BP measurement. Engagement will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all 11 activities completed). The participants in the intervention arm will be grouped into 3 engagement phenotypes based on their scores: 1) Persistently Low, 2) Intermediate Declining, and 3) Persistently High.
次要结局
- Percentage of Participants Who Have Any ADL or IADL Impairment(Baseline, 3 months)
- Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS)(3 months)
- 12-Item Short Form Survey (SF-12) Score(Month 3)
- Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status)(Baseline, 3 months)
- Number of Hospital Readmissions(1 Year)
- Number of Participants Who Died From Any Cause(1 Year)