Cardiovascular DiseasesMACRONCT03922529
Modified Application of Cardiac Rehabilitation for Older Adults
A study testing MACRO-I in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Daniel Forman, MD at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Rehabilitation, Transition of Care
- What is being tested?
- MACRO-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Nov 2019to 8 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Pittsburgh Healthcare system
Pittsburgh, Pennsylvania, 15240
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
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.
Read the 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.
- Being tested
- MACRO-I, Usual Care
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACRO-IBehavioural
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Care after an acute heart event will be at the discretion of the participants' clinical providers. Receives: Other: Usual Care |
| MACRO-I | Experimental | A coaching intervention that supplements usual care. Receives: Behavioral: MACRO-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months, i.e., Baseline to 3-month change
Secondary outcomes (36)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12-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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12-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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start4 Nov 2019
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Forman, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Washington University School of Medicine, University of Pittsburgh
- Responsible party
- Sponsor-investigator, Daniel Forman, MD, University of Pittsburgh
- Investigators
- Daniel E Forman, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922529
- Sponsor's protocol ID
- STUDY20080044
- Other IDs
- 1R01AG060499-01
- Acronym
- MACRO
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2019
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Application of Cardiac Rehabilitation for Older Adults
- ClinicalTrials.gov ID
- NCT03922529
- Acronym / sponsor ID
- MACRO / STUDY20080044
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Daniel Forman, MDUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Washington University School of Medicine, University of Pittsburgh
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareCare after an acute heart event will be at the discretion of the participants' clinical providers. |
| MACRO-I | Experimental | Behavioral: MACRO-IA coaching intervention that supplements usual care. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MACRO-IMACRO-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. | Behavioural | MACRO-I |
| Usual CareParticipants 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. | Other | Usual Care |
Primary outcome
AM-PAC-CAT - Basic Mobility Domain
Time frame: 3 months, i.e., Baseline to 3-month change
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.
36 secondary outcomes
AM-PAC-CAT - Basic Mobility Domain
Time frame: Baseline to 6-month change
AM-PAC-CAT - Basic Mobility Domain
Time frame: Baseline to 12-month change
AM-PAC-CAT - Daily Activity Domain
Time frame: Baseline to 3-month change
AM-PAC-CAT - Daily Activity Domain
Time frame: Baseline to 6-month change
AM-PAC-CAT - Daily Activity Domain
Time frame: Baseline to 12-month change
Accelerometry
Time frame: Baseline to 3-month change
Accelerometry
Time frame: Baseline to 6-month change
Accelerometry
Time frame: Baseline to 12-month change
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
Time frame: Baseline to 3-month change
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
Time frame: Baseline to 6-month change
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
Time frame: Baseline to 12-month change
Morley Frail Scale
Time frame: Baseline to 3-month change
Morley Frail Scale
Time frame: Baseline to 6-month change
Morley Frail Scale
Time frame: Baseline to 12-month change
Sullivan Cardiac Self-Efficacy
Time frame: Baseline to 3-month change
Sullivan Cardiac Self-Efficacy
Time frame: Baseline to 6-month change
Sullivan Cardiac Self-Efficacy
Time frame: Baseline to 12-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
Time frame: Baseline to 3-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
Time frame: Baseline to 6-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
Time frame: Baseline to 12-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
Time frame: Baseline to 3-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
Time frame: Baseline to 6-month change
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
Time frame: Baseline to 12-month change
Cardiac Rehabilitation Participation
Time frame: 3 months
Hospitalizations
Time frame: 12 months
Duke Activity Status Index (DASI)
Time frame: Baseline to 3-month Change
Duke Activity Status Index (DASI)
Time frame: Baseline to 6-month Change
Duke Activity Status Index (DASI)
Time frame: Baseline to 12-month Change
Rapid Eating Assessment for Participants (Modified REAP-S)
Time frame: Baseline to 3-month Change
Rapid Eating Assessment for Participants (Modified REAP-S)
Time frame: Baseline to 6-month Change
Rapid Eating Assessment for Participants (Modified REAP-S)
Time frame: Baseline to 12-month Change
Readiness for Change
Time frame: Baseline
Readiness for Change
Time frame: 3 Months
Readiness for Change
Time frame: 6 Months
Readiness for Change
Time frame: 12 Months
Fall Assessment
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E Forman principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MACRO-I in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Daniel Forman, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AM-PAC-CAT - Basic Mobility Domain (time frame: 3 months, i.e., Baseline to 3-month change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.