Modified Application of Cardiac Rehabilitation for Older Adults

  • STATUS
    Recruiting
  • End date
    Aug 26, 2024
  • participants needed
    480
  • sponsor
    University of Pittsburgh
Updated on 26 January 2021
stenosis
heart failure
heart disease
myocardial infarction
infarct
percutaneous coronary intervention
cardiac rehabilitation
acute coronary syndrome
coronary artery bypass graft

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 IdentifierNCT03922529
SponsorUniversity of Pittsburgh
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Cardiovascular Disease or Cardiac Rehabilitation or Transition of Care?
Do you have any of these conditions: cardiovascular disorders or Transition of Care or rehabilitation cardiac or cardiovascular disease (cvd) or Cardiovascular Disease or Cardiac Rehabili...?
Do you have any of these conditions: Cardiac Rehabilitation or Cardiovascular Disease or Transition of Care or cardiovascular system diseases or cardiovascular diseases or rehabilitation ...?
Do you have any of these conditions: Cardiac Rehabilitation or cardiovascular disease (cvd) or Cardiovascular Disease or rehabilitation cardiac or cardiovascular disorders or Transition o...?
Age 70 year
Eligible cardiovascular disease (CVD) diagnosis (hospitalization for Acute myocardial infarction (AMI)/ Acute coronary syndrome (ACS), stable Ischemic Heart Disease , revascularization Coronary artery bypass graft surgery and Percutaneous Coronary Intervention[CABG, PCI], valvular heart disease [specifically, surgical or percutaneous intervention for mitral regurgitation or aortic stenosis], or heart failure (HF))
English speaking
able to provide written informed consent
able to be assessed and undergo study interventions

Exclusion Criteria

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 or cannot consent (as indicated by medical record)
Long-term care resident at admission with no plans to return to independent living
anticipates inability to return for required reassessments at 3, 6 and 12 months
long-term care residents at admission with no plans to return to independent living
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