Cardiovascular disease is the leading cause of mortality and morbidity globally. With widespread and growing use of smart phones and mobile devices, the use of mobile health (mHealth) in transmission of physiologic parameters and patient-referred symptoms to healthcare providers and researchers, as well as reminders and care plan applications from providers to patients, has potential to revolutionize both clinical care and the conduct of clinical trials with improved designs, data capture, and potentially lower costs. In randomized early phase proof-of-concept studies, focusing on lifestyle intervention, there is evidence that mHealth technology can improve outcomes. By contrast, results from small randomized controlled trials that tested mHealth interventions in heart failure patients were disappointing with inconsistent findings. These inconclusive results could be partially attributed to a lack of methodological rigor (insufficient sample size, quasi-experimental design, inadequate mHealth equipment). Therefore, there is an urgent need to develop systematic evidence-based guidelines and parameters for mHealth to be effectively utilized in cardiovascular clinical trials.
Keywords: Clinical trials; Endpoints; Heart failure; Mobile health.
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