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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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.
NYU Langone Health
New York, New York, United States
RECRUITINGChange 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).
Time frame: 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).
Time frame: 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.
Time frame: Month 3
Change in step count
Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.
Time frame: Week 1, Month 3
Change in step count
Step count is measured on a continuous basis and data will be obtained from the wearable activity monitoring device.
Time frame: Week 1, Month 12
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
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.
Time frame: Baseline, Month 3
Change in European Quality of Life Questionnaire - 5 Dimensions (EQ-5D) score
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.
Time frame: Baseline, Month 12
Change in visual analogue scale (VAS) score
VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.
Time frame: Baseline, Month 3
Change in visual analogue scale (VAS) score
VAS indicates the general health status (VAS; ranges from 0-100). Higher scores indicating the better health status.
Time frame: Baseline, Month 12
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
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).
Time frame: Baseline, Month 3
Change in patient Health Questionnaire - 8 Items (PHQ-8) score
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).
Time frame: Baseline, Month 12
Change in exercise time on treadmill stress test
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.
Time frame: Baseline, Month 3
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