Modified Application of Cardiac Rehabilitation for Older Adults
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- STATUS
- Recruiting
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- End date
- Aug 26, 2024
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- participants needed
- 480
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- sponsor
- University of Pittsburgh
Summary
Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical gap in cardiovascular disease (CVD) management by melding cardiac rehabilitation (CR) principles with geriatric risk modifying strategies in an intentional and flexible treatment approach. MACRO is designed to optimize accessibility and effectiveness, and to augment the potential for recovery from CVD events that are highly prevalent and otherwise prognostically dire. MACRO constitutes an important advance in geriatric cardiology wherein the conventional approach to CVD care is transmuted and enriched by linking cardiovascular management to the broader complexity of aging.
Description
This is a pragmatic randomized controlled trial (RCT) of 480 older adults eligible for cardiac rehabilitation (CR): hospitalized adults aged 70 years with a primary diagnosis of acute myocardial infarction (AMI)/ Acute coronary syndrome (ACS), stable Ischemic Heart Disease (IHD),Coronary artery bypass graft surgery (CABG), Percutaneous Coronary Intervention (PCI), valvular heart disease (valve replacements or repairs for aortic stenosis or mitral regurgitation), or heart failure (HF). Participants who consent to participate will be randomly assigned to Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) or standard of care (SOC) arms (which may include CR at the discretion of the providers). In the MACRO arm, participants will benefit from personalized engagement, de-prescribing, and CR will be explicitly facilitated, risk stratification will be utilized to determine the best option of CR care from flexible range of options (site-, home, or hybrid). While SOC may include CR, the SOC CR provides no specialized engagement, and no programmatic facilitation, enhancement, customization, or deliberate flexibility in how care is provided. It will be entirely standard care.
Aim 1: To establish efficacy, safety and acceptability of the MACRO intervention.
Investigators hypothesize that after 3 months, compared to standard of care (SOC), participants randomized into the MACRO arm will have:
H1.1: Greater improvements in the Short Physical Performance Battery (SPPB) (primary outcome); H1.2: Greater improvements in physical activity (accelerometry), depression; cognition; frailty; self-efficacy; and quality of life; H1.3: Greater CR participation and adherence; H1.4: Greater impact in readmissions and hospitalization.
Aim 2: To examine duration of benefit from the MACRO compared to SOC H2.1: the investigators hypothesize that relative MACRO benefits (in outcomes, safety, and utilization) will persist after 6 and 12 months
Aim 3: To explore characteristics of participants who benefit the most from the MACRO intervention.
H3.1: the investigators anticipate functional capacity and other baseline characteristics will identify those who benefit from the MACRO intervention (exploratory).
Details
| Condition | Cardiovascular Disease, Cardiac Rehabilitation, Transition of Care, rehabilitation cardiac, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders |
|---|---|
| Treatment | Standard of Care, MACRO |
| Clinical Study Identifier | NCT03922529 |
| Sponsor | University of Pittsburgh |
| Last Modified on | 26 January 2021 |
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