Modified Application of Cardiac Rehabilitation for Older Adults
- Conditions
- Cardiovascular DiseasesCardiac RehabilitationTransition of Care
- Interventions
- Behavioral: MACRO-IOther: Usual Care
- Registration Number
- NCT03922529
- Lead Sponsor
- University of Pittsburgh
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MACRO-I MACRO-I A coaching intervention that supplements usual care. Usual Care Usual Care Care after an acute heart event will be at the discretion of the participants' clinical providers.
- Primary Outcome Measures
Name Time Method AM-PAC-CAT - Basic Mobility Domain 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.
- Secondary Outcome Measures
Name Time Method AM-PAC-CAT - Basic Mobility Domain Baseline to 12-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.
AM-PAC-CAT - Daily Activity Domain Baseline to 12-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 Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.
Accelerometry Baseline to 12-month change 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.
PATIENT HEALTH QUESTIONNAIRE (PHQ-9) Baseline to 12-month change PHQ-9 is a 9 item depression scale. Scores range form 0-27 with the higher score showing the greater possibility of depression.
Morley Frail Scale Baseline to 12-month change 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.
Sullivan Cardiac Self-Efficacy Baseline to 12-month change The self-efficacy scale evaluates an individuals confidence to take care of them self in association to their cardiac disease. Scored on 0 to 52 for a total score with the higher the score indicating higher confidence.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score Baseline to 12-month change 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.
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score Baseline to 12-month change 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.
Cardiac Rehabilitation participation 3 months 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.
Hospitalizations 12 months 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.
Duke Activity Status Index (DASI) Baseline to 12-month Change 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.
Rapid Eating Assessment for Participants (modified REAP-S) Baseline to 12-month Change 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.Readiness for Change 12 Months 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.
Fall Assessment 12 months 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).
Trial Locations
- Locations (3)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
VA Pittsburgh Healthcare system
🇺🇸Pittsburgh, Pennsylvania, United States