The mGlide mobile health intervention, which achieved blood pressure control in 89% of patients versus 54% with usual care in a 50-patient pilot study, will be evaluated in a proposed 450-patient randomized controlled trial to improve hypertension management in high-risk minority populations.
RCT (n=450)
Open-label
Site-specific randomization
Yes
Does the mGlide mobile health intervention improve hypertension control rates compared to state-of-clinical care in stroke survivors and high-risk primary care patients with uncontrolled hypertension?
This protocol outlines a randomized controlled trial to evaluate whether a mobile health intervention with wireless blood pressure monitoring and pharmacist co-management improves hypertension control in diverse, high-risk populations.
BACKGROUND: Suboptimal 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 smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. OBJECTIVE: The mGlide randomized controlled trial is a National Institutes of Health-funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional 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: To date, we have randomized 107 participants (54 intervention, 53 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25424.
Lakshminarayan et al. (2020) conducted an RCT in Uncontrolled hypertension (n=450). mGlide mobile health intervention vs. State-of-clinical-care comparison (usual care) was evaluated on Rate of hypertension control at 6 and 12 months. The mGlide mobile health intervention, which achieved blood pressure control in 89% of patients versus 54% with usual care in a 50-patient pilot study, will be evaluated in a proposed 450-patient randomized controlled trial to improve hypertension management in high-risk minority populations.