Modified Application of Cardiac Rehabilitation for Older Adults

NCT03922529 | Completed Results DMC

• 2 other identifiers: STUDY200800441R01AG060499-01
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiovascular Diseases; Cardiac Rehabilitation; Transition of Care

Outcome Measures

Primary Outcomes (1)

• AM-PAC-CAT - Basic Mobility Domain

  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.

  3 months, i.e., Baseline to 3-month change

Secondary Outcomes (36)

• AM-PAC-CAT - Basic Mobility Domain

  Baseline to 6-month change

• AM-PAC-CAT - Basic Mobility Domain

  Baseline to 12-month change

• AM-PAC-CAT - Daily Activity Domain

  Baseline to 3-month change

• AM-PAC-CAT - Daily Activity Domain

  Baseline to 6-month change

• AM-PAC-CAT - Daily Activity Domain

  Baseline to 12-month change

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

MACRO-I

EXPERIMENTAL

A coaching intervention that supplements usual care.

Behavioral: MACRO-I

Interventions

MACRO-I 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.

MACRO-I

Usual Care 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.

Usual Care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel Forman, MD: lead
• National Institute on Aging (NIA): collaborator
• Washington University School of Medicine: collaborator
• University of Pittsburgh: collaborator

Study Sites (3)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

VA Pittsburgh Healthcare system

Pittsburgh, Pennsylvania, 15240, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Daniel Forman, MD
• Organization: University of Pittsburgh

formand@pitt.edu

412-360-2411

Study Officials

• Daniel E Forman

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Key investigators and well as the outcomes assessor at each site will remain blinded to participant group placement.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: There will be two intervention groups 1) MACRO-I in which the research team will work with the participant and providers to facilitate CR; 2) Usual care as determined by their clinical providers.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 22, 2019
• Study Start: November 4, 2019
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)