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Recruiting NCT05933083

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

No phase Interventional Myocardial Infarction Heart Failure, Systolic Heart Valve Diseases Angina, Stable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: In-person cardiac rehabilitation, Telehealth cardiac rehabilitation.
Who it may be relevant to
Registry conditions: Myocardial Infarction, Heart Failure, Systolic, Heart Valve Diseases, Angina, Stable. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in six minute walk distance [Time frame: Baseline and 12 months]
Secondary outcome measures (12)
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health [Time frame: Baseline and 12 months]
  • Change in PROMIS Global Health 10 Scores - Physical Health [Time frame: Baseline and 12 months]
  • Change in Generalized Anxiety Disorder (GAD)-7 [Time frame: Baseline and 12 months]
  • Change in Patient Health Questionnaire (PHQ)-9 [Time frame: Baseline and 12 months]
  • Blood pressure control [Time frame: 12 months]
  • Participation in cardiac rehabilitation [Time frame: 12 months]
  • Survival free of hospitalization for myocardial infarction, heart failure, or stroke/TIA. [Time frame: 24 months]
  • Change in PROMIS Global Health 10 Scores - Mental Health [Time frame: Baseline and 3 months]
  • Change in PROMIS Global Health 10 Scores - Mental Health [Time frame: Baseline and 24 months]
  • Change in PROMIS Global Health 10 Scores - Physical Health [Time frame: Baseline and 3 months]
  • Change in PROMIS Global Health 10 Scores - Physical Health [Time frame: Baseline and 24 months]
  • Change in GAD-7 [Time frame: Baseline and 3 months]

Eligibility criteria

Inclusion criteria

  • Age 18 or older
  • Eligible for cardiac rehabilitation
  • Diagnosis within 1 year prior to consent
  • Myocardial infarction
  • Percutaneous coronary intervention
  • Coronary artery bypass
  • Heart valve repair or replacement
  • Heart transplant
  • Chronic stable angina, or
  • Chronic systolic heart failure (ejection fraction ≤ 35%)
  • Referred to cardiac rehabilitation by a doctor or advanced practice provider for another indication that is covered by the participant's insurance, such as heart failure with preserved ejection fraction or aortic surgery.
  • Willing to be randomized to in-person or telehealth cardiac rehabilitation
  • Able to communicate in English or Spanish

Exclusion criteria

  • Unstable arrhythmias which may make unmonitored exercise unsafe (e.g., history of ventricular tachycardia not on medical therapy and without an implantable cardioverter defibrillator)
  • Unsafe for patient to participate in the opinion of the investigator
  • Hospice
  • Unable to consent for self

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 5 centers
  • University of California, San Francisco — San Francisco
  • Denver Health — Denver
  • Johns Hopkins University Medical Center — Baltimore
  • University of Michigan — Ann Arbor
  • University of Pittsburgh Medical Center — Pittsburgh

Identifiers

NCT: NCT05933083 · IHS-2021C3-24147

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗