Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2025-03-21
2028-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mHealth-Cardiac Rehabilitation (CR)
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).
Communication with exercise therapist
A personalized exercise program will be designed. The assigned therapist will identify potential barriers to this plan and develop mitigation strategies. The assigned therapist will then make phone contact with participants weekly for the duration of the study. Exercise recommendations will be titrated during calls based on review of activity data.
mHealth-CR
mHealth-CR software (currently, from Corrie Health) will permit 1) participant data entry about exercise; 2) viewing of educational material pertinent to the condition.
Wearable activity monitoring device
Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
Usual Care
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.
Wearable activity monitoring device
Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
Interventions
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Communication with exercise therapist
A personalized exercise program will be designed. The assigned therapist will identify potential barriers to this plan and develop mitigation strategies. The assigned therapist will then make phone contact with participants weekly for the duration of the study. Exercise recommendations will be titrated during calls based on review of activity data.
mHealth-CR
mHealth-CR software (currently, from Corrie Health) will permit 1) participant data entry about exercise; 2) viewing of educational material pertinent to the condition.
Wearable activity monitoring device
Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Harmony Reynolds, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-01040
Identifier Type: -
Identifier Source: org_study_id
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