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出境医 / 临床实验 / Modified Application of Cardiac Rehabilitation for Older Adults (MACRO)
Modified Application of Cardiac Rehabilitation for Older Adults (MACRO)
Study Description
Brief Summary:
Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical gap in cardiovascular disease (CVD) management by melding cardiac rehabilitation (CR) principles with geriatric risk modifying strategies in an intentional and flexible treatment approach. MACRO is designed to optimize accessibility and effectiveness, and to augment the potential for recovery from CVD events that are highly prevalent and otherwise prognostically dire. MACRO constitutes an important advance in geriatric cardiology wherein the conventional approach to CVD care is transmuted and enriched by linking cardiovascular management to the broader complexity of aging.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Cardiac Rehabilitation Transition of Care | Behavioral: MACRO Other: Standard of Care | Not Applicable |
Detailed Description:
This is a pragmatic randomized controlled trial (RCT) of 480 older adults eligible for cardiac rehabilitation (CR): hospitalized adults aged ≥70 years with a primary diagnosis of acute myocardial infarction (AMI)/ Acute coronary syndrome (ACS), stable Ischemic Heart Disease (IHD),Coronary artery bypass graft surgery (CABG), Percutaneous Coronary Intervention (PCI), valvular heart disease (valve replacements or repairs for aortic stenosis or mitral regurgitation), or heart failure (HF). Participants who consent to participate will be randomly assigned to Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) or standard of care (SOC) arms (which may include CR at the discretion of the providers). In the MACRO arm, participants will benefit from personalized engagement, de-prescribing, and CR will be explicitly facilitated, risk stratification will be utilized to determine the best option of CR care from flexible range of options (site-, home, or hybrid). While SOC may include CR, the SOC CR provides no specialized engagement, and no programmatic facilitation, enhancement, customization, or deliberate flexibility in how care is provided. It will be entirely standard care.
Aim 1: To establish efficacy, safety and acceptability of the MACRO intervention.
Investigators hypothesize that after 3 months, compared to standard of care (SOC), participants randomized into the MACRO arm will have:
H1.1: Greater improvements in the Short Physical Performance Battery (SPPB) (primary outcome); H1.2: Greater improvements in physical activity (accelerometry), depression; cognition; frailty; self-efficacy; and quality of life; H1.3: Greater CR participation and adherence; H1.4: Greater impact in readmissions and hospitalization.
Aim 2: To examine duration of benefit from the MACRO compared to SOC H2.1: the investigators hypothesize that relative MACRO benefits (in outcomes, safety, and utilization) will persist after 6 and 12 months
Aim 3: To explore characteristics of participants who benefit the most from the MACRO intervention.
H3.1: the investigators anticipate functional capacity and other baseline characteristics will identify those who benefit from the MACRO intervention (exploratory).
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 480 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | There will be two intervention groups 1) Standard of Care (SoC) arm which will receive care as determined by their clinical providers. 2) Modified application of cardiac rehabilitation for older adults (MACRO) arm in which the research team will work with the participant and providers to increase facilitation of care in addition to providing enhanced medical rehab goal setting. |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Masking Description: | Key investigators and well as the outcomes assessor at each site will remain blinded to participant group placement. |
| Primary Purpose: | Supportive Care |
| Official Title: | Modified Application of Cardiac Rehabilitation for Older Adults |
| Actual Study Start Date : | November 4, 2019 |
| Estimated Primary Completion Date : | August 2023 |
| Estimated Study Completion Date : | August 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Standard of Care
Care after an acute heart event will be at the discretion of the participants clinical providers.
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Other: Standard of Care
Participants will follow the standard of care hospital practice that is recommended for the participant. The study will follow the participant for the course of the study to see the comparison to the MACRO arm
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Experimental: MACRO
Research staff will provided personalized engagement, de-prescribing, and explicitly facilitate enrollment into Cardiac Rehabilitation with risk assessment placement to determined the best fit of a flexible range of options of cardiac rehab (site-, home, or hybrid).
|
Behavioral: MACRO
Modified application of cardiac rehabilitation for older adults (MACRO) intervention transforms Cardiac Rehabilitation by organizing relative to participants' goals of care and composite risks rather than central emphasis on cardiovascular disease (CVD). Participants are engaged, assessed for their goals of care as well as their risks, and education is initiated to best facilitate informed choices regarding realistic and practical strategies. Selection of site-, home-, or hybrid-based care is based on which option will best meet that individual participant's preferences and comprehensive needs. preferences and needs, and utilizing a flexible range of options (site-, home, or hybrid).
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Outcome Measures
Primary Outcome Measures :
- Short Physical Performance Battery (SPPB) [ Time Frame: After 3 months ]The Short Physical Performance Battery (SPPB) assesses balance, gait speed, and 5 chair raise. Creating a composite score form 0-12 with 12 being a higher score 0 being the lowest score.
Secondary Outcome Measures :
- Accelerometry [ Time Frame: After 3 months ]Change in life style physical activity will be measured by wrist worn accelerometry to assess change in movement. We will look specifically at change in step count, vector magnitude, and change in intensity level. Higher the number the better.
- PATIENT HEALTH QUESTIONNAIRE (PHQ-9). [ Time Frame: After 3 months ]PHQ 9 is a 9 item depression scale. Scores range form 0-27 with the higher score showing the greater possibility of depression.
- National institutes of health toolbox cognition battery (NIH toolbox) [ Time Frame: After 3 months ]Is an online (will be completed on an IPAD) set of question that allow assessment of change in cognition. This assessment is optional and may not be completed on all participants .
- Fried frailty Assessment [ Time Frame: After 3 months ]FRIED assessment is a questionnaire the looks at frailty through both physical measures and questions looking at change in body habitus and cognition. Frail: ≥3 criteria present; Intermediate or Pre-Frail:1 or 2 criteria present; Robust : 0 criteria present
- Sullivan Cardiac Self-Efficacy [ Time Frame: After 3 months ]the self-efficacy scale evaluates an individuals confidence to take care of them self in association to their cardiac disease. Scored on zero to 52 for a total score with the higher the score showing the more confident a person is.
- THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) [ Time Frame: After 3 months ]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 and adherence [ Time Frame: After 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. The greater number of sessions attended the better usually ranging from zero to 36
- Readmission/Hospitalization [ Time Frame: After 3 months ]Participants will be asked about as well as participants medical records to evaluate readmission to the hospital. Based on the total number of events the lower the number the better
- Short Physical Performance Battery (SPPB) [ Time Frame: After 6 and 12 months ]The Short Physical Performance Battery (SPPB) assesses balance, gait speed, and 5 chair raise creating a composite score form 0-12 with 12 being a higher score.
Eligibility Criteria
| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥70 year
- Eligible cardiovascular disease (CVD) diagnosis (hospitalization for Acute myocardial infarction (AMI)/ Acute coronary syndrome (ACS), stable Ischemic Heart Disease , revascularization Coronary artery bypass graft surgery and Percutaneous Coronary Intervention[CABG, PCI], valvular heart disease [specifically, surgical or percutaneous intervention for mitral regurgitation or aortic stenosis], or heart failure (HF))
- 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 or cannot consent (as indicated by medical record)
- Long-term care resident at admission with no plans to return to independent living
- anticipates inability to return for required reassessments at 3, 6 and 12 months
- long-term care residents at admission with no plans to return to independent living.
Contacts and Locations
Contacts
| Contact: Daniel E Forman | 412-864-2507 | formand@pitt.edu | |
| Contact: Tara Stakich | 412-864-2082 | tss54@pitt.edu |
Locations
| United States, Missouri | |
| Washington University in St. Louis | Recruiting |
| Saint Louis, Missouri, United States, 63130 | |
| Contact: Eric Lenze, MD 314-362-5154 | |
| Contact: Angela Stevens 314-362-5154 | |
| Principal Investigator: Eric Lenze, MD | |
| United States, Pennsylvania | |
| VA Pittsburgh Healthcare system | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| Contact: Daniel Forman 412-360-2411 daneil.forman@va.gov | |
| Contact: Tara Stakich 412-864-2082 tss54@pitt.edu | |
| Principal Investigator: Daniel Forman, MD | |
Sponsors and Collaborators
University of Pittsburgh
National Institute on Aging (NIA)
Washington University School of Medicine
Investigators
| Principal Investigator: | Daniel E Forman | University of Pittsburgh |
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | April 15, 2019 | ||||||||
| First Posted Date ICMJE | April 22, 2019 | ||||||||
| Last Update Posted Date | December 2, 2020 | ||||||||
| Actual Study Start Date ICMJE | November 4, 2019 | ||||||||
| Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Short Physical Performance Battery (SPPB) [ Time Frame: After 3 months ] The Short Physical Performance Battery (SPPB) assesses balance, gait speed, and 5 chair raise. Creating a composite score form 0-12 with 12 being a higher score 0 being the lowest score.
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| Original Primary Outcome Measures ICMJE |
SPPB [ Time Frame: After 3 months ] The Short Physical Performance Battery (SPPB) assesses balance, gait speed, and 5 chair raise creating a composite score form 0-12 with 12 being a higher score.
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Modified Application of Cardiac Rehabilitation for Older Adults | ||||||||
| Official Title ICMJE | Modified Application of Cardiac Rehabilitation for Older Adults | ||||||||
| Brief Summary | Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical gap in cardiovascular disease (CVD) management by melding cardiac rehabilitation (CR) principles with geriatric risk modifying strategies in an intentional and flexible treatment approach. MACRO is designed to optimize accessibility and effectiveness, and to augment the potential for recovery from CVD events that are highly prevalent and otherwise prognostically dire. MACRO constitutes an important advance in geriatric cardiology wherein the conventional approach to CVD care is transmuted and enriched by linking cardiovascular management to the broader complexity of aging. | ||||||||
| Detailed Description |
This is a pragmatic randomized controlled trial (RCT) of 480 older adults eligible for cardiac rehabilitation (CR): hospitalized adults aged ≥70 years with a primary diagnosis of acute myocardial infarction (AMI)/ Acute coronary syndrome (ACS), stable Ischemic Heart Disease (IHD),Coronary artery bypass graft surgery (CABG), Percutaneous Coronary Intervention (PCI), valvular heart disease (valve replacements or repairs for aortic stenosis or mitral regurgitation), or heart failure (HF). Participants who consent to participate will be randomly assigned to Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) or standard of care (SOC) arms (which may include CR at the discretion of the providers). In the MACRO arm, participants will benefit from personalized engagement, de-prescribing, and CR will be explicitly facilitated, risk stratification will be utilized to determine the best option of CR care from flexible range of options (site-, home, or hybrid). While SOC may include CR, the SOC CR provides no specialized engagement, and no programmatic facilitation, enhancement, customization, or deliberate flexibility in how care is provided. It will be entirely standard care. Aim 1: To establish efficacy, safety and acceptability of the MACRO intervention. Investigators hypothesize that after 3 months, compared to standard of care (SOC), participants randomized into the MACRO arm will have: H1.1: Greater improvements in the Short Physical Performance Battery (SPPB) (primary outcome); H1.2: Greater improvements in physical activity (accelerometry), depression; cognition; frailty; self-efficacy; and quality of life; H1.3: Greater CR participation and adherence; H1.4: Greater impact in readmissions and hospitalization. Aim 2: To examine duration of benefit from the MACRO compared to SOC H2.1: the investigators hypothesize that relative MACRO benefits (in outcomes, safety, and utilization) will persist after 6 and 12 months Aim 3: To explore characteristics of participants who benefit the most from the MACRO intervention. H3.1: the investigators anticipate functional capacity and other baseline characteristics will identify those who benefit from the MACRO intervention (exploratory). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: There will be two intervention groups 1) Standard of Care (SoC) arm which will receive care as determined by their clinical providers. 2) Modified application of cardiac rehabilitation for older adults (MACRO) arm in which the research team will work with the participant and providers to increase facilitation of care in addition to providing enhanced medical rehab goal setting. Masking: Double (Investigator, Outcomes Assessor)Masking Description: Key investigators and well as the outcomes assessor at each site will remain blinded to participant group placement. Primary Purpose: Supportive Care
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
480 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 2024 | ||||||||
| Estimated Primary Completion Date | August 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 70 Years and older (Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03922529 | ||||||||
| Other Study ID Numbers ICMJE | PRO18040009 1R01AG060499-01 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Daniel Forman, MD, University of Pittsburgh | ||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Pittsburgh | ||||||||
| Verification Date | December 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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