mHealth-CArdiac REhabilitation for INOCA

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06829160
Status
Recruiting
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Conditions

  • Ischemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Communication with exercise therapist — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.

Study Details

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.

Key Dates

Start date
Mar 21, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
May 31, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Active Comparator: 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.

Primary Outcome Measure

Change in Seattle Angina Questionnaire (SAQ) score [ Time Frame: Baseline, Month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

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