mHealth-CArdiac REhabilitation for INOCA
ConditionIschemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Seattle Angina Questionnaire (SAQ) = 100
Non-ambulatory
Pregnant
Moderate or severe cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Communication with exercise therapist
BehavioralA 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
BehavioralmHealth-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
BehavioralParticipants will be offered the Fitbit Charge 5. This commercially available product measures physical activity.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: mHealth-Cardiac Rehabilitation (CR)Experimental treatment 3 interventions
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 32
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 123
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 3Secondary outcomes
1
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 32
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 123
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 34
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 12Other outcomes
1
Change in rose Dyspnea Scale (RDS) score
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).
Time frame
Baseline, Month 32
Change in rose Dyspnea Scale (RDS) score
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).
Time frame
Baseline, Month 123
Change in perceived Stress Scale 4 (PSS-4) score
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.
Time frame
Baseline, Month 34
Change in perceived Stress Scale 4 (PSS-4) score
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.
Time frame
Baseline, Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov