Language: BG BG
← Back to results
Recruiting Not applicable NCT06829160

mHealth-CArdiac REhabilitation for INOCA

No applicable phase (e.g. observational)
Conditions: Ischemia

Sponsor: NYU Langone Health

trial.available_in: БГ
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.
Who can participate
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.
Interventions
Communication with exercise therapist
BEHAVIORAL
mHealth-CR
BEHAVIORAL
Wearable activity monitoring device
BEHAVIORAL
Locations 1
United States (1)
NYU Langone Health
New York , New York
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.03.2025
Completion date
01.05.2029
Registry ID
NCT06829160
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.