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NCT Number: NCT06829160

mHealth-CArdiac REhabilitation for INOCA

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Seattle Angina Questionnaire (SAQ) score

    Time frame: Baseline, Month 3

    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).

  2. Change in Seattle Angina Questionnaire (SAQ) score

    Time frame: Baseline, Month 12

    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).

  3. Weekly percent completion of the mHealth-CR program

    Time frame: Month 3

    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.

Secondary outcomes

  1. Change in step count

    Time frame: Week 1, Month 3

    Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.

  2. Change in step count

    Time frame: Week 1, Month 12

    Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.

  3. Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score

    Time frame: Baseline, Month 3

    The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

  4. Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score

    Time frame: Baseline, Month 12

    The EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem). A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

  5. Change in visual analogue scale (VAS) score

    Time frame: Baseline, Month 3

    VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.

  6. Change in visual analogue scale (VAS) score

    Time frame: Baseline, Month 12

    VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.

  7. Change in patient Health Questionnaire - 8 Items (PHQ-8) score

    Time frame: Baseline, Month 3

    The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).

  8. Change in patient Health Questionnaire - 8 Items (PHQ-8) score

    Time frame: Baseline, Month 12

    The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).

  9. Change in exercise time on treadmill stress test

    Time frame: Baseline, Month 3

    The treadmill stress test measures how well the participants heart works during physical activity. This test will take about 30 minutes in total, with about 10-15 minutes spent exercising.

Other outcomes

  1. Change in rose Dyspnea Scale (RDS) score

    Time frame: Baseline, Month 3

    The RDS is a questionnaire that assesses how much shortness of breath a patient experiences during daily activities. The scale has four items indicating whether patients experience breathlessness with different activities (scores range from 0 to 4, with higher scores indicating dyspnea with milder activities).

  2. Change in rose Dyspnea Scale (RDS) score

    Time frame: Baseline, Month 12

    The RDS is a questionnaire that assesses how much shortness of breath a patient experiences during daily activities. The scale has four items indicating whether patients experience breathlessness with different activities (scores range from 0 to 4, with higher scores indicating dyspnea with milder activities).

  3. Change in perceived Stress Scale 4 (PSS-4) score

    Time frame: Baseline, Month 3

    The PSS-4 is a self-reported questionnaire consisting of four questions designed to measure how stressful a person perceives their life to be over the past month. Scores range from 0 to 16, with higher scores indicating greater perceived stress levels.

  4. Change in perceived Stress Scale 4 (PSS-4) score

    Time frame: Baseline, Month 12

    The PSS-4 is a self-reported questionnaire consisting of four questions designed to measure how stressful a person perceives their life to be over the past month. Scores range from 0 to 16, with higher scores indicating greater perceived stress levels.

  5. Number of cardiovascular hospitalizations

    Time frame: Month 12

    Outcome measure will be assessed through review of the electronic health record (EHR).

Study contacts

Contact information is provided by the study sponsor or research team.

Harmony Reynolds, MD

CONTACT

[email protected]

212-263-7751

John Dodson, MD

CONTACT

[email protected]

212-263-7751

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 17, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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