A mHealth Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Design of mGlide RCT (Preprint)
BACKGROUND Sub-optimal treatment of hypertension remains a widespread problem particularly among minorities and socioeconomically disadvantaged groups. We present a health-system based intervention with diverse patient populations using readily available smart phone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. OBJECTIVE mGlide RCT is a NIH-funded randomized controlled trial, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. METHODS We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150) and community medical centers including Federally Qualified Health Centers serving low income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. RESULTS Enrollment. To date, we have randomized 104 participants (52 intervention; 52 control). CONCLUSIONS This study will provide evidence for whether a readily available mHealth-care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. CLINICALTRIAL Clinicaltrials.gov NCT03612271