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Modified Application of Cardiac Rehabilitation in Older Adults (MACRO) Trial: Protocol changes in a pragmatic multi-site randomized controlled trial in response to the COVID-19 pandemic.
Forman, Daniel E; Racette, Susan B; Toto, Pamela E; Peterson, Linda R; Glynn, Nancy W; Pruskowski, Jennifer; Byard, Thomas; Delligatti, Amanda; Lolley, Rebecca; Mulkareddy, Vinaya; Allsup, Kelly; Perera, Subashan; Lenze, Eric J; Rich, Michael W.
  • Forman DE; University of Pittsburgh, Divisions of Geriatrics and Cardiology, and Pittsburgh Veteran Affairs, GRECC, Pittsburgh, PA, United States of America. Electronic address: formand@pitt.edu.
  • Racette SB; Washington University, School of Medicine, Program in Physical Therapy and Department of Medicine, Washington University, St. Louis, MO, United States of America.
  • Toto PE; University of Pittsburgh Department of Occupational Therapy, Pittsburgh, PA, United States of America.
  • Peterson LR; Washington University, Department of Medicine, St. Louis, MO, United States of America.
  • Glynn NW; University of Pittsburgh, Center for Aging and Population Health, Department of Epidemiology, Graduate School of Public Health, Pittsburgh, PA, United States of America.
  • Pruskowski J; Pittsburgh Veteran Affairs, GRECC, University of Pittsburgh, University of Pittsburgh, Division of Geriatrics, Pittsburgh, PA, United States of America.
  • Byard T; University of Pittsburgh, Division of Geriatrics, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.
  • Delligatti A; Veterans Health Foundation, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.
  • Lolley R; University of Pittsburgh Medical Center, Heart and Vascular Institute, Pittsburgh, PA, United States of America.
  • Mulkareddy V; University of Pittsburgh Medical Center, Heart and Vascular Institute, Pittsburgh, PA, United States of America.
  • Allsup K; VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.
  • Perera S; University of Pittsburgh, Division of Geriatrics, Pittsburgh, PA, United States of America.
  • Lenze EJ; Washington University, Department of Psychiatry, St Louis, MO, United States of America.
  • Rich MW; Washington University, Department of Medicine, St. Louis, MO, United States of America.
Contemp Clin Trials ; 112: 106633, 2022 01.
Article in English | MEDLINE | ID: covidwho-1525718
ABSTRACT

BACKGROUND:

Older adults are at higher risk for cardiovascular disease and functional decline, often leading to deterioration and dependency. Cardiac rehabilitation (CR) provides opportunity to improve clinical and functional recovery, yet participation in CR decreases with age. Modified Application of CR in Older Adults (MACRO) is a National Institute on Aging (NIA)-funded pragmatic trial that responds to this gap by aiming to increase enrollment of older adults into CR and improving functional outcomes. This article describes the methodology and novel features of the MACRO trial.

METHODS:

Randomized, controlled trial of a coaching intervention (MACRO-I) vs. usual care for older adults (age ≥ 70 years) eligible for CR after an incident cardiac hospitalization. MACRO-I incorporates innovations including holistic risk assessments, flexible CR format (i.e., helping patients to select a CR design that aligns with their personal risks and preferences), motivational prompts, nutritional emphasis, facilitated deprescription, enhanced education, and home visits. Key modifications were necessitated by the COVID-19 pandemic, including switching from a performance-based primary endpoint (Short Physical Performance Battery) to a patient-reported measure (Activity Measure for Post-Acute Care Computerized Adaptive Testing). Changes prompted by COVID-19 maintain the original intent of the trial and provide key methodologic advantages.

CONCLUSIONS:

MACRO is exploring a novel individualized coaching intervention to better enable older patients to participate in CR. Due to COVID-19 many aspects of the MACRO protocol required modification, but the primary objective of the trial is maintained and the updated protocol will more effectively achieve the original goals of the study.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / Cardiac Rehabilitation / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / Cardiac Rehabilitation / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Long Covid Limits: Aged / Humans Language: English Journal: Contemp Clin Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article