MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05933083
Status
Recruiting
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Conditions

  • Angina, Stable
  • Coronary Artery Disease
  • Heart Failure, Systolic
  • Heart Transplant
  • Heart Valve Diseases
  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • In-person cardiac rehabilitation — BEHAVIORAL
    In-person exercise training, health education, and counseling
  • Telehealth cardiac rehabilitation — BEHAVIORAL
    Telehealth exercise training, health education, and counseling

Study Details

Cardiac rehabilitation is a medically recommended program for patients with certain heart conditions. It includes exercise training, health education, and counseling. Unfortunately, many patients do not participate in cardiac rehabilitation. Some find it challenging to attend the in-person sessions. This study aims to compare two methods of delivering cardiac rehabilitation: in-person and through telehealth. The investigators want to know if the effects of these two programs are alike and if certain individuals benefit more from one program over the other.

Key Dates

Start date
Oct 27, 2023
Status verified
Sep 2025
Primary completion
Oct 15, 2026
Completion
Oct 15, 2027

Study Design

Enrollment
516 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: In-person cardiac rehabilitation
    Participants will participate in 12-week in-person cardiac rehabilitation as delivered at the site where they are enrolled. The typical course is 36 sessions of group exercise, health education, and counseling over 12 weeks.
  • Active Comparator: Telehealth cardiac rehabilitation
    Participants will participate in 12-week telehealth cardiac rehabilitation. The program will follow the same core components as in-person cardiac rehabilitation, but in-person supervised exercise will not be required. The core element of telehealth cardiac rehabilitation is 12 weekly individual telehealth sessions between the patient and cardiac rehabilitation provider.

Primary Outcome Measure

Change in six minute walk distance [ Time Frame: Baseline and 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Alisa Boyd, MPH
[email protected]
415-502-6191
Alexis Beatty, MD (PRINCIPAL_INVESTIGATOR)
Denver HealthDenverColorado80204
Tanner Bryan
[email protected]
303-602-2880
Pamela Douglas, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University Medical CenterBaltimoreMaryland21287
Seth Martin, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48105
Brahmajee Nallamothu, MD (PRINCIPAL_INVESTIGATOR)
Jessica Golbus, MD (SUB_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
Daniel Forman, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CADenver Health· Denver, COJohns Hopkins University Medical Center· Baltimore, MDUniversity of Michigan· Ann Arbor, MIUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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