Overview
This is a multi-site phase II, 2:1 pragmatic randomized trial of 250 participants within the NYU Langone Health (NYULH) and Emory University Medical Center system to evaluate mobile health cardiac rehabilitation (mHealth-CR) in patients who meet clinical criteria for INOCA (ischemia and no obstructive coronary disease on imaging). Participants will be randomized to mHealth-CR or usual care. The study intervention takes place for 3 months which is the time period for most traditional CR programs.
The overall study goals are threefold: 1) to evaluate whether an mHealth-CR intervention that includes activity tracking, weekly counseling, and exercise documentation, improves health status (i.e., symptoms, function, and quality of life) in patients with INOCA at 3 months; 2) to evaluate effects of the mHealth-CR intervention vs. usual care on physical activity and exercise capacity, general health status, and depressive symptoms (secondary endpoints). We will also evaluate effects on primary and secondary outcomes at 6 months and 1 year; and 3) to characterize engagement and elucidate any factors that limit engagement.
Eligibility
Inclusion Criteria:
- Age 18 and over
- Diagnosis of Ischemia with Non-Obstructive Coronary Arteries (INOCA) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive Coronary artery disease (CAD) on computed tomography (CT) or invasive angiography
Exclusion Criteria:
- Seattle Angina Questionnaire (SAQ) = 100
- Non-ambulatory
- Pregnant
- Moderate or severe cognitive impairment
- Unable/willing to provide consent
- Incarcerated
- Unable to use mHealth
- Severe osteoarthritis or joint replacement within 3 months
- Parkinsons disease or other movement disorders
- Regular use of walker
- Life expectancy \< 12 months
- Clinical judgement concerning other safety or non-adherence issues
- Unable to read and communicate in English since the app content is currently only available in English.
