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Recruiting NCT06829160

mHealth-CArdiac REhabilitation for INOCA

No phase Interventional Ischemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Communication with exercise therapist, mHealth-CR, Wearable activity monitoring device.
Who it may be relevant to
Registry conditions: Ischemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.
  • Behavioral Wearable activity monitoring device
    Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.

Primary outcome measures

  • Change in Seattle Angina Questionnaire (SAQ) score [Time frame: Baseline, Month 3]
  • Change in Seattle Angina Questionnaire (SAQ) score [Time frame: Baseline, Month 12]
  • Weekly percent completion of the mHealth-CR program [Time frame: Month 3]
Secondary outcome measures (9)
  • Change in step count [Time frame: Week 1, Month 3]
  • Change in step count [Time frame: Week 1, Month 12]
  • Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score [Time frame: Baseline, Month 3]
  • Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score [Time frame: Baseline, Month 12]
  • Change in visual analogue scale (VAS) score [Time frame: Baseline, Month 3]
  • Change in visual analogue scale (VAS) score [Time frame: Baseline, Month 12]
  • Change in patient Health Questionnaire - 8 Items (PHQ-8) score [Time frame: Baseline, Month 3]
  • Change in patient Health Questionnaire - 8 Items (PHQ-8) score [Time frame: Baseline, Month 12]
  • Change in exercise time on treadmill stress test [Time frame: Baseline, Month 3]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06829160 · 23-01040 · 1R01HL170666-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗