mHealth-CArdiac REhabilitation for INOCA
2 other identifiers
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedStudy Start
First participant enrolled
March 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
April 23, 2026
April 1, 2026
2.3 years
February 11, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Seattle Angina Questionnaire (SAQ) score
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Baseline, Month 3
Change in Seattle Angina Questionnaire (SAQ) score
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Baseline, Month 12
Weekly percent completion of the mHealth-CR program
Weekly engagement will be measured as the fraction of the following elements completed each week: exercise therapy-directed activities, daily entry of exercise data and rated perceived exertion (RPE); completed weekly phone call with exercise therapist; at least one communication with exercise therapist (outside weekly phone call); reviewing educational video/text (which will vary by week). Competition will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all activities completed) incorporating values for each activity.
Month 3
Secondary Outcomes (9)
Change in step count
Week 1, Month 3
Change in step count
Week 1, Month 12
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
Baseline, Month 3
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
Baseline, Month 12
Change in visual analogue scale (VAS) score
Baseline, Month 3
- +4 more secondary outcomes
Other Outcomes (5)
Change in rose Dyspnea Scale (RDS) score
Baseline, Month 3
Change in rose Dyspnea Scale (RDS) score
Baseline, Month 12
Change in perceived Stress Scale 4 (PSS-4) score
Baseline, Month 3
- +2 more other outcomes
Study Arms (2)
mHealth-Cardiac Rehabilitation (CR)
EXPERIMENTALParticipants 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).
Usual Care
ACTIVE COMPARATORParticipants in usual care arm will receive standard medical care as determined by their physician. They will also use a wearable wrist activity monitoring device.
Interventions
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 software (currently, from Corrie Health) will permit 1) participant data entry about exercise; 2) viewing of educational material pertinent to the condition.
Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harmony Reynolds, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2025
First Posted
February 17, 2025
Study Start
March 21, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
May 1, 2029
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to harmony.reynolds@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: harmony.reynolds@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.