Ischemia
Conditions
Keywords
INOCA, ANOCA, Ischemia, no obstructive coronary artery disease
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.
Interventions
BEHAVIORALCommunication 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.
BEHAVIORALmHealth-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.
BEHAVIORALWearable activity monitoring device
Participants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Seattle Angina Questionnaire (SAQ) score | 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). |
| Weekly percent completion of the mHealth-CR program | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in step count | Week 1, Month 3 | Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device. |
| Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score | 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. |
| Change in visual analogue scale (VAS) score | Baseline, Month 3 | VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status. |
| Change in patient Health Questionnaire - 8 Items (PHQ-8) score | 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). |
| Change in exercise time on treadmill stress test | 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. |
Countries
United States
Contacts
CONTACTHarmony Reynolds, MD
CONTACTJohn Dodson, MD
PRINCIPAL_INVESTIGATORHarmony Reynolds, MD
NYU Langone Health
Outcome results
None listed