Modified Application of Cardiac Rehabilitation for Older Adults

Cardiovascular Diseases Clinical Trial

— MACRO  

Official title:

Modified Application of Cardiac Rehabilitation for Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03922529
• Other study ID #: STUDY20080044
• Secondary ID: 1R01AG060499-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 374
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Cardiovascular Diseases
• Transition of Care

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare system	Pittsburgh	Pennsylvania
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA), Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 0-100 with higher scores indicating greater activity levels/fewer limitations.	3 months, i.e., baseline to 3-month change
Secondary	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 0-100 with higher scores indicating greater activity levels/fewer limitations.	Baseline to 6-month and 12-month change
Secondary	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 0-100 with higher scores indicating greater activity levels/fewer limitations.	3-, 6-, and 12-month change
Secondary	Accelerometry	Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of gait acceleration will be prioritized.	3-, 6-, and 12-month change
Secondary	PATIENT HEALTH QUESTIONNAIRE (PHQ-9)	PHQ-9 is a 9 item depression scale. Scores range form 0-27 with the higher score showing the greater possibility of depression.	3-, 6-, and 12-month change
Secondary	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.	3-, 6-, and 12-month change
Secondary	Sullivan Cardiac Self-Efficacy	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.	3-, 6-, and 12-month change
Secondary	THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12)	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.	3-, 6-, and 12-month change
Secondary	Cardiac Rehabilitation participation and adherence	Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants' medical records to evaluate utilization of cardiac rehab. Number of sessions attended range from 0 to 36. It is assumed that more sessions attended is better.	3-, 6-, and 12-month change
Secondary	Readmission/Hospitalization	Participants will be asked about readmissions during blinded monthly calls and follow-up assessments. Participants' medical records may also be reviewed to evaluate readmission to the hospital. It is assumed that a lower number of readmissions/hospitalizations is better.	3-, 6-, and 12-month change