Clinical trial NCT06829160: mHealth-CArdiac REhabilitation for INOCA
Official title: mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemia
Keywords: INOCA
ANOCA
Ischemia
no obstructive coronary artery disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-02-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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.

Primary outcomes:
measure: Change in Seattle Angina Questionnaire (SAQ) score
timeFrame: Baseline, Month 3
measure: Change in Seattle Angina Questionnaire (SAQ) score
timeFrame: Baseline, Month 12
measure: Weekly percent completion of the mHealth-CR program
timeFrame: Month 3
Secondary outcomes:
measure: Change in step count
timeFrame: Week 1, Month 3
measure: Change in step count
timeFrame: Week 1, Month 12
measure: Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
timeFrame: Baseline, Month 3
measure: Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
timeFrame: Baseline, Month 12
measure: Change in visual analogue scale (VAS) score
timeFrame: Baseline, Month 3
measure: Change in visual analogue scale (VAS) score
timeFrame: Baseline, Month 12
measure: Change in patient Health Questionnaire - 8 Items (PHQ-8) score
timeFrame: Baseline, Month 3
measure: Change in patient Health Questionnaire - 8 Items (PHQ-8) score
timeFrame: Baseline, Month 12
measure: Change in exercise time on treadmill stress test
timeFrame: Baseline, Month 3
Other outcomes:
measure: Change in rose Dyspnea Scale (RDS) score
timeFrame: Baseline, Month 3
measure: Change in rose Dyspnea Scale (RDS) score
timeFrame: Baseline, Month 12
measure: Change in perceived Stress Scale 4 (PSS-4) score
timeFrame: Baseline, Month 3
measure: Change in perceived Stress Scale 4 (PSS-4) score
timeFrame: Baseline, Month 12
measure: Number of cardiovascular hospitalizations
timeFrame: Month 12
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Harmony Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: