Design of a randomized controlled trial comparing a mobile phone-based hypertension health coaching application to home blood pressure monitoring alone: The Smart Hypertension Control Study

Background: Hypertension is a major cause of morbidity and mortality but frequently remains uncontrolled. A smartphone application that provides coaching regarding home blood pressure monitoring and other aspects of hypertension self-care and related behavior change may be a scalable way to help manage hypertension. Methods/design: The Smart Hypertension Control Study is a prospective, randomized controlled trial to assess the effects of a hypertension personal control program (HPCP), which consists of an automated artificial intelligence smartphone application that provides individualized support and coaching to promote home monitoring and healthy behavior changes related to hypertension self-management. Enrolled adults with uncontrolled hypertension will be randomized in a 1:1 fashion to the HPCP with home blood pressure monitoring or to home monitoring alone. We plan to enroll 350 participants, with a target of 300 participants with complete six-month follow-up data. The primary study outcome will be systolic blood pressure at six months. Additional outcomes include measures of antihypertensive medication adherence, home blood pressure monitoring practices, self-management practices, weight, and self-reported health behaviors. Conclusion: The Smart Hypertension Control Study will evaluate blood pressure and hypertension self-management behavior outcomes in participants with uncontrolled hypertension exposed to a smartphone-based hypertension health coaching application in addition to home blood pressure monitoring compared to those exposed to home blood pressure monitoring alone.