mHealth-CArdiac REhabilitation for INOCA

NYU Langone Health

Status: Enrolling

Conditions: Ischemia

Treatments: Behavioral: Communication with exercise therapist; Behavioral: Wearable activity monitoring device; Behavioral: mHealth-CR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06829160

23-01040

1R01HL170666-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

mHealth-Cardiac Rehabilitation (CR)

Experimental group

Description:

Participants in the mHealth-CR arm will receive daily therapist-directed activity and weekly phone calls, use a mHealth-CR app to track activity, heart rate and access educational materials, and use a wearable wrist activity monitoring device (such as Fitbit or Apple Watch).

Treatment:

Behavioral: mHealth-CR

Behavioral: Wearable activity monitoring device

Behavioral: Communication with exercise therapist

Usual Care

Active Comparator group

Description:

Participants in usual care arm will receive standard medical care as determined by their physician. They will also use a wearable wrist activity monitoring device.

Treatment:

Behavioral: Wearable activity monitoring device