Clinical trial NCT03922529: Modified Application of Cardiac Rehabilitation for Older Adults
Official title: Modified Application of Cardiac Rehabilitation for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Cardiac Rehabilitation
Transition of Care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Washington University School of Medicine
First posted: 2019-04-22
Enrollment: 350
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: AM-PAC-CAT - Basic Mobility Domain
timeFrame: 3 months, i.e., Baseline to 3-month change
Secondary outcomes:
measure: AM-PAC-CAT - Basic Mobility Domain
timeFrame: Baseline to 6-month change
measure: AM-PAC-CAT - Basic Mobility Domain
timeFrame: Baseline to 12-month change
measure: AM-PAC-CAT - Daily Activity Domain
timeFrame: Baseline to 3-month change
measure: AM-PAC-CAT - Daily Activity Domain
timeFrame: Baseline to 6-month change
measure: AM-PAC-CAT - Daily Activity Domain
timeFrame: Baseline to 12-month change
measure: Accelerometry
timeFrame: Baseline to 3-month change
measure: Accelerometry
timeFrame: Baseline to 6-month change
measure: Accelerometry
timeFrame: Baseline to 12-month change
measure: PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
timeFrame: Baseline to 3-month change
measure: PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
timeFrame: Baseline to 6-month change
measure: PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
timeFrame: Baseline to 12-month change
measure: Morley Frail Scale
timeFrame: Baseline to 3-month change
measure: Morley Frail Scale
timeFrame: Baseline to 6-month change
measure: Morley Frail Scale
timeFrame: Baseline to 12-month change
measure: Sullivan Cardiac Self-Efficacy
timeFrame: Baseline to 3-month change
measure: Sullivan Cardiac Self-Efficacy
timeFrame: Baseline to 6-month change
measure: Sullivan Cardiac Self-Efficacy
timeFrame: Baseline to 12-month change
measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
timeFrame: Baseline to 3-month change
measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
timeFrame: Baseline to 6-month change
measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
timeFrame: Baseline to 12-month change
measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
timeFrame: Baseline to 3-month change
measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
timeFrame: Baseline to 6-month change
measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
timeFrame: Baseline to 12-month change
measure: Cardiac Rehabilitation participation
timeFrame: 3 months
measure: Hospitalizations
timeFrame: 12 months
measure: Duke Activity Status Index (DASI)
timeFrame: Baseline to 3-month Change
measure: Duke Activity Status Index (DASI)
timeFrame: Baseline to 6-month Change
measure: Duke Activity Status Index (DASI)
timeFrame: Baseline to 12-month Change
measure: Rapid Eating Assessment for Participants (modified REAP-S)
timeFrame: Baseline to 3-month Change
measure: Rapid Eating Assessment for Participants (modified REAP-S)
timeFrame: Baseline to 6-month Change
measure: Rapid Eating Assessment for Participants (modified REAP-S)
timeFrame: Baseline to 12-month Change
measure: Readiness for Change
timeFrame: Baseline
measure: Readiness for Change
timeFrame: 3 Months
measure: Readiness for Change
timeFrame: 6 Months
measure: Readiness for Change
timeFrame: 12 Months
measure: Fall Assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare system
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Daniel E Forman
role: PRINCIPAL_INVESTIGATOR
References: