Modified Application of Cardiac Rehabilitation for Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 5
- 主要终点
- AM-PAC-CAT - Basic Mobility Domain
研究概览
简要总结
Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical underuse of cardiac rehabilitation in older adults with a coaching model that addresses issues related to aging as a means to better facilitate cardiac rehabilitation (CR). MACRO is a randomized controlled trial (RCT) in which older adults with a CVD event are randomized between a MACRO intervention (MACRO-I) versus usual care. The MACRO-I is designed to facilitate CR as a means to augment functional recovery.
详细描述
This is a pragmatic RCT of 350 older adults eligible for CR: hospitalized adults aged ≥70 years with a primary diagnosis of acute myocardial infarction/ acute coronary syndrome, stable ischemic heart disease, revascularization (coronary artery bypass graft surgery, percutaneous coronary intervention), valvular heart disease (surgical or transcatheter valve replacement or repair), heart failure (with reduced or preserved ejection fraction) or peripheral arterial disease. Participants who consent to participate will be randomly assigned to a MACRO-intervention (MACRO-I) versus usual care. In the MACRO-I arm, participants receive coaching that incorporates innovative features designed to address needs of older adults. These include holistic risk assessment (medical, functional, psychosocial), guidance to facilitate CR in a format that aligns with each patient's own risks as well as their preferences (i.e., CR formatted as either site-based, home-based, or in a hybrid format [site transitioning to home]), behavioral reinforcements to promote CR based on their goals of care, and deprescribing of sedating medications. While usual care may include CR, it provides no coaching, and none of the innovations associated with MACRO-I coaching. Endpoints focus particularly on functional capacity achieved by improved implementation of CR.
Aim 1: To establish efficacy, safety, and acceptability of the MACRO-I via a RCT.
We hypothesize that after 3 months, compared to usual care, participants randomized into MACRO-I will have:
H1.1: Greater improvements in function as measured by Activity Measure for Post-Acute Care Computer Adaptive Test (AM-PAC-CAT) Basic Mobility Domain (3 month changes; primary outcome).
H1.2: Greater improvements in function as measured by AM-PAC CAT daily activity domain; accelerometry; depression; frailty; self-efficacy; quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Key investigators and well as the outcomes assessor at each site will remain blinded to participant group placement.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥70 year
- •Eligible cardiovascular disease (CVD) diagnosis (hospitalization for acute myocardial infarction/ acute coronary syndrome, stable ischemic heart disease, revascularization (coronary artery bypass graft surgery and percutaneous coronary intervention, valvular heart disease (surgical or transcatheter replacements or repair for mitral regurgitation or aortic stenosis),heart failure (exacerbation or new diagnosis)
- •English speaking
- •Able to provide written informed consent
- •Able to be assessed and undergo study interventions
排除标准
- •Unstable medical condition as indicated by history, physical exam, and/or laboratory findings
- •Presence of non-CVD conditions likely to be fatal within 12 months (e.g., metastatic cancer)
- •Severe cognitive impairment: Short Blessed screening with a score of 13 or greater cannot consent (as indicated by medical record)
- •Long-term care resident at admission with no plans to return to independent living
- •Unable to participate in follow-up assessments by telephone or in person
研究组 & 干预措施
MACRO-I
A coaching intervention that supplements usual care.
干预措施: MACRO-I (Behavioral)
Usual Care
Care after an acute heart event will be at the discretion of the participants' clinical providers.
干预措施: Usual Care (Other)
结局指标
主要结局
AM-PAC-CAT - Basic Mobility Domain
时间窗: 3 months, i.e., Baseline to 3-month change
AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.
次要结局
- AM-PAC-CAT - Basic Mobility Domain(Baseline to 12-month change)
- AM-PAC-CAT - Daily Activity Domain(Baseline to 12-month change)
- Accelerometry(Baseline to 12-month change)
- PATIENT HEALTH QUESTIONNAIRE (PHQ-9)(Baseline to 12-month change)
- Morley Frail Scale(Baseline to 12-month change)
- Sullivan Cardiac Self-Efficacy(Baseline to 12-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score(Baseline to 12-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score(Baseline to 12-month change)
- Hospitalizations(12 months)
- Duke Activity Status Index (DASI)(Baseline to 12-month Change)
- Readiness for Change(12 Months)
- Fall Assessment(12 months)
- Accelerometry(Baseline to 12-month change)
- PATIENT HEALTH QUESTIONNAIRE (PHQ-9)(Baseline to 12-month change)
- Morley Frail Scale(Baseline to 12-month change)
- AM-PAC-CAT - Basic Mobility Domain(Baseline to 12-month change)
- AM-PAC-CAT - Daily Activity Domain(Baseline to 12-month change)
- Sullivan Cardiac Self-Efficacy(Baseline to 12-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score(Baseline to 12-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score(Baseline to 12-month change)
- Cardiac Rehabilitation Participation(3 months)
- Hospitalizations(12 months)
- Duke Activity Status Index (DASI)(Baseline to 12-month Change)
- Rapid Eating Assessment for Participants (Modified REAP-S)(Baseline to 12-month Change)
- Readiness for Change(12 Months)
- Fall Assessment(12 months)
- AM-PAC-CAT - Basic Mobility Domain(Baseline to 6-month change)
- AM-PAC-CAT - Daily Activity Domain(Baseline to 3-month change)
- AM-PAC-CAT - Daily Activity Domain(Baseline to 6-month change)
- Accelerometry(Baseline to 3-month change)
- Accelerometry(Baseline to 6-month change)
- PATIENT HEALTH QUESTIONNAIRE (PHQ-9)(Baseline to 3-month change)
- PATIENT HEALTH QUESTIONNAIRE (PHQ-9)(Baseline to 6-month change)
- Morley Frail Scale(Baseline to 3-month change)
- Morley Frail Scale(Baseline to 6-month change)
- Sullivan Cardiac Self-Efficacy(Baseline to 3-month change)
- Sullivan Cardiac Self-Efficacy(Baseline to 6-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score(Baseline to 3-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score(Baseline to 6-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score(Baseline to 3-month change)
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score(Baseline to 6-month change)
- Duke Activity Status Index (DASI)(Baseline to 3-month Change)
- Duke Activity Status Index (DASI)(Baseline to 6-month Change)
- Rapid Eating Assessment for Participants (Modified REAP-S)(Baseline to 3-month Change)
- Rapid Eating Assessment for Participants (Modified REAP-S)(Baseline to 6-month Change)
- Readiness for Change(Baseline)
- Readiness for Change(3 Months)
- Readiness for Change(6 Months)
研究者
Daniel Forman, MD
Professor
University of Pittsburgh