Modified Application of Cardiac Rehabilitation for Older Adults

NCT ID: NCT03922529

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2024-08-08

Brief Summary

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.

Detailed Description

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.

H1.3: Greater CR participation and adherence. H1.4: Greater impact on readmissions and hospitalization.

Aim 2: To examine the durability of benefit of MACRO-I compared to usual care.

We hypothesize that after 6 and 12 months (12 months will be captured as timing allows), compared to usual care, participants randomized into MACRO-I will have:

H2.1: Greater improvement in AM-PAC-CAT basic mobility and daily activity domains; accelerometry; depression; frailty; self-efficacy; quality of life.

H2.2: Greater impact in readmissions and hospitalization at 6 and 12 months (12 months will be captured as timing allows).

Aim 3: To explore characteristics of patients who benefit the most from the MACRO-I as compared to usual care.

H3.1: We anticipate functional capacity and other baseline characteristics will identify those who benefit from the MACRO-I (exploratory).

The MACRO study originally began recruitment with a target sample size of N=480 in November 2019. The primary outcome measure at this time was the Short Physical Performance Battery (SPPB), and a battery of secondary outcome measures included assessments of hand grip strength, accelerometry, cognition, depression, health literacy, frailty, physical activity, nutrition, readiness for change, self efficacy, and quality of life. However, the COVID-19 pandemic disrupted the original MACRO protocol. In March 2020 per Data Safety and Monitoring Board (DSMB) decision, all study participants who were enrolled at that time were withdrawn and the study was suspended to address safety concerns of face-to-face assessments during the height of the pandemic. It was necessary to modify the protocol so it could administered fully remotely, without changing the original aims and innovation of the intervention.

The SPPB was no longer feasible or safe as a primary outcome measure, so the study team selected the Activity Measure for Post-Acute Care with Computerized Adaptive Testing (AM-PAC CAT). The AM-PAC CAT is used to measure self-reported daily activity, can reliably be used to detect change over time, and can be administered over the phone. It was determined that with this new outcome measure, a target sample size of N=374 would be sufficient to retain the same statistical power for the new primary outcome as the original protocol, assuming 80% retention. The secondary outcome assessments were also revised, changing to measures that could be administered remotely when needed and leaving in-person assessments optional contingent on COVID risk.

Following all regulatory approvals of the revised protocol and outcome measures, the study restarted recruitment in September 2020. Enrollment concluded in August 2023 after 416 participants had been consented and 350 randomized. The retention rate was higher than anticipated at 87.7% completion of the primary outcome measure at 3 months, which allowed for the same amount of power with a smaller sample size.

Conditions

Cardiovascular Diseases; Cardiac Rehabilitation; Transition of Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

Care after an acute heart event will be at the discretion of the participants' clinical providers.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.

MACRO-I

A coaching intervention that supplements usual care.

Group Type: EXPERIMENTAL

MACRO-I

Intervention Type: BEHAVIORAL

MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.

Interventions

MACRO-I

MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.

Intervention Type: BEHAVIORAL

Usual Care

Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Daniel Forman, MD

OTHER

Sponsor Role: lead

Responsible Party

Daniel Forman, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniel E Forman

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Washington University in St. Louis

St Louis, Missouri, United States

VA Pittsburgh Healthcare system

Pittsburgh, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AG060499-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20080044

Identifier Type: -

Identifier Source: org_study_id