Modified Application of Cardiac Rehabilitation for Older Adults — MACRO  

Cardiovascular Diseases Clinical Trial

Official title: Modified Application of Cardiac Rehabilitation for Older Adults

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This is a pragmatic RCT of 374 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). ;

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Diseases
• Transition of Care

• NCT number: NCT03922529
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2019
• Completion date: December 2024