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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Eligible for cardiac rehabilitation

Diagnosis within 1 year prior to consent

Myocardial infarction

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • In-person cardiac rehabilitation

    Behavioral

    In-person exercise training, health education, and counseling

  • Telehealth cardiac rehabilitation

    Behavioral

    Telehealth exercise training, health education, and counseling

Treatment groups

516 Participants
are divided into 2 treatment groups
Group A: In-person cardiac rehabilitationActive comparator 1 intervention
Group B: Telehealth cardiac rehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in six minute walk distance

The distance walked in six minute on a standard course will be measured in meters at baseline and 12 months.

Time frame
Baseline and 12 months

Secondary outcomes

1

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Scores - Mental Health

A change in PROMIS Global Health 10 scores will be measured during the first 12 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions with a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and

Time frame
Baseline and 12 months
2

Change in PROMIS Global Health 10 Scores - Physical Health

A change in PROMIS Global Health 10 scores will be measured during the first 12 months of the study. The PROMIS Global Health 10 questionnaire is a self-assessed questionnaire that asks participants to respond to 10 questions. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score. Higher scores represent better physical health.

Time frame
Baseline and 12 months
3

Change in Generalized Anxiety Disorder (GAD)-7

A change in GAD-7 scores will be measured during the first 12 months of the study. The GAD-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 7 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 21. Higher scores represent more anxiety symptoms.

Time frame
Baseline and 12 months
4

Change in Patient Health Questionnaire (PHQ)-9

A change in PHQ-9 scores will be measured during the first 12 months of the study. The PHQ-7 questionnaire is a self-assessed questionnaire that asks participants to respond to 9 questions with response option scores ranging from 0 to 3. The scale ranges from 0 to 27. Higher scores represent more depressive symptoms.

Time frame
Baseline and 12 months

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Mayo Clinic

Collaborator

University of Michigan

Collaborator

University of Pittsburgh

Collaborator

Johns Hopkins University

Collaborator