Modified Application of Cardiac Rehabilitation for Older Adults (MACRO)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cardiac Rehabilitation; Transition of Care
• Intervention / Treatment: Other: Usual Care; Behavioral: MACRO-I

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.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University in St. Louis
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Care after an acute heart event will be at the discretion of the participants' clinical providers.	Other: 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.
Experimental: MACRO-I; A coaching intervention that supplements usual care.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6-month change
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.	Baseline to 12-month change
AM-PAC-CAT - Daily Activity Domain	AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.	Baseline to 3-month change
AM-PAC-CAT - Daily Activity Domain	AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.	Baseline to 6-month change
AM-PAC-CAT - Daily Activity Domain	AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.	Baseline to 12-month change
Accelerometry	Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.	Baseline to 3-month change
Accelerometry	Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.	Baseline to 6-month change
Accelerometry	Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.	Baseline to 12-month change
Morley Frail Scale	The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.	Baseline to 3-month change
Morley Frail Scale	The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.	Baseline to 6-month change
Morley Frail Scale	The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.	Baseline to 12-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score	RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.	Baseline to 3-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score	RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.	Baseline to 6-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score	RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.	Baseline to 12-month change
Hospitalizations	Participants will be asked about hospitalizations during blinded monthly calls and follow-up assessments. Participants' medical records may also be reviewed to evaluate readmission to the hospital. Rate of hospitalizations per person year will be reported by group. It is assumed that a lower number of hospitalizations is better.	12 months
Duke Activity Status Index (DASI)	The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.	Baseline to 3-month Change
Duke Activity Status Index (DASI)	The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.	Baseline to 6-month Change
Duke Activity Status Index (DASI)	The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.	Baseline to 12-month Change
Readiness for Change	Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. An increased readiness for change is associated with greater likelihood of goal attainment.	Baseline
Readiness for Change	Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.	3 Months
Readiness for Change	Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.	6 Months
Readiness for Change	Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.	12 Months
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)	The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.	Baseline to 3-month change
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)	The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.	Baseline to 6-month change
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)	The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.	Baseline to 12-month change
Sullivan Cardiac Self-Efficacy	The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.	Baseline to 3-month change
Sullivan Cardiac Self-Efficacy	The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.	Baseline to 6-month change
Sullivan Cardiac Self-Efficacy	The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.	Baseline to 12-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score	The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.	Baseline to 3-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score	The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.	Baseline to 6-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score	The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.	Baseline to 12-month change
Cardiac Rehabilitation Participation	Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants' medical records to evaluate utilization of cardiac rehab. Participation is measured as the number of sessions attended which ranges from 0 to 36. It is assumed that more sessions attended is better.	3 months
Rapid Eating Assessment for Participants (Modified REAP-S)	The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.	Baseline to 3-month Change
Rapid Eating Assessment for Participants (Modified REAP-S)	The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.	Baseline to 6-month Change
Rapid Eating Assessment for Participants (Modified REAP-S)	The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.	Baseline to 12-month Change
Fall Assessment	Falls are a common, deleterious, and expensive aspect of aging which may be preventable via the tenets of MACRO such as good transitional care, age-appropriate exercise, and de-prescribing. We will measure falls as follows: at baseline, we will ask, "Have you had any falls in the past 3 months?" In follow-up assessments, we will ask about interim falls, as well as their severity (e.g., if they caused injury). For the outcome assessment, the count of participants in each group who reported having at least one fall over the 12 month period following randomization is reported.	12 months

Collaborators and Investigators

• Sponsor: Daniel Forman, MD
• Collaborators: Washington University School of Medicine; University of Pittsburgh; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Daniel E Forman, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: STUDY20080044; 1R01AG060499-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No