mHealth-CArdiac REhabilitation for INOCA (INOCA-CARE)
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PROJECT SUMMARY. Patients with ischemia with no obstructive coronary artery disease (INOCA) experience debilitating symptoms that include angina, dyspnea, and fatigue. Management of INOCA is challenging, both because there is no option for coronary revascularization to improve symptoms and because available medications are often insufficient. There are also marked sex and gender-related differences, with women experiencing more severe symptoms as well as higher prevalence of disease. Millions of patients are affected by INOCA in the US. While cardiac rehabilitation (CR) has strong potential to improve outcomes in patients with INOCA, angina patients are rarely referred (~7% overall, likely lower for INOCA). Even when they are referred, patients face multiple barriers that include long distances to facilities, high out-of-pocket costs, transportation issues, and competing needs such as work and caregiving responsibilities. These barriers are consistently higher in women. Given the limitations of traditional CR, there has been a recent proliferation of mobile health-enabled CR platforms (mHealth-CR) that use portable electronic devices to deliver CR at home. mHealth-CR seeks to replicate components of traditional CR (e.g., exercise counseling) while adding remote monitoring technology to quantify physical activity and other metrics. While mHealth-CR programs are now widely available, to our knowledge they have not yet been tested in patients with INOCA. Given that INOCA is characterized by worse quality of life than obstructive CAD, higher prevalence in women, and poor correlation between symptoms and ischemia, the efficacy of mHealth-CR needs to be evaluated before being prescribed in routine practice. In this context, we designed INOCA-CARE (mHealth-CArdiac REhabilitation for INOCA), a phase II pragmatic randomized trial of 250 participants at 2 sites with clinical expertise in INOCA (NYU Langone Health and Emory Healthcare). We anticipate the cohort will be two-thirds female based on prevalence of INOCA, defined as positive stress test for ischemia and no obstructive coronary disease on imaging. Participants will be randomized 2:1 to mHealth-CR, delivered over 3 months, or usual care, and will be followed for 12 months. All analyses will consider sex as a biological variable and gender as a sociocultural variable in explaining outcomes and engagement given the higher prevalence of INOCA and greater symptom burden among women. In Aim 1, we will test whether an mHealth-CR intervention improves outcomes at 3 months, including angina-related health status (primary endpoint), overall (1a) and by sex and gender-related variables (GRV) (1b). In Aim 2, we will evaluate effects of the intervention vs. usual care on physical activity, general health status, depression (secondary endpoints), overall (2a) and by sex and GRV (2b). We will also evaluate effects at 6 months and 1 year. In Aim 3, we will characterize engagement with mHealth-CR and elucidate barriers to participation, overall (3a) and by sex and GRV (3b). The MPIs are physician scientists with complementary expertise in INOCA and sex differences (Reynolds) and mHealth interventions (Dodson).
