A Randomized Pilot Trial of a Digital Health Platform To Control BP To Address Stroke Disparities

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Stroke is a leading cause of disability, cognitive impairment, and death. The COVID-19 pandemic has surfaced longstanding and severe health disparities in a range of conditions, including stroke. Compared to other groups, African American individuals have a higher prevalence of stroke risk factors, including hypertension, diabetes mellitus, high cholesterol, and peripheral vascular disease. These factors are compounded by differences in socioeconomic status, leading to higher stroke prevalence and mortality. However, there is growing evidence to suggest that most strokes can be prevented by controlling modifiable risk factors. The guiding assumption in this research is that interventions targeting blood pressure (BP) control in people of color can narrow racial and ethnic disparities in stroke recurrence. Although there is limited research, it has been shown that telehealth can be effectively used to reduce BP in populations of color. The proposed research leverages preliminary work by the investigative team on stroke disparities to conduct a pilot randomized control trial (RCT) in an African American and Afro-Caribbean population in Central Brooklyn. The proposed studies are informed by a TRANSCREATION implementation science framework and an intervention model we developed called the Digital Equity for Stroke Approach (DESA). DESA’s innovation lies in integrating four novel components: provision of broadband internet (or equivalent) to address the digital divide, enhanced family caregiver support, flexible (telehealth, text, email) remote two-way communication between patient and clinician, and real-time remote BP monitoring. The proposal is constituted by three aims, corresponding to the following stages: pre-trial preparatory RCT and post-trial phases that examine facilitators and barriers. We will employ a convergent mixed method design to guide data collection and analysis. The first aim lays the foundation for the RCT by developing a digital equity plan, assessing user experience, and conducting preliminary telehealth experiments to ensure usability, flow and address implementation issues. In the pilot RCT, we will test whether the DESA group will lead to a net reduction in BP control and improvement in medication adherence in the participant group compared to usual care. We will randomize stroke patients into a 9-month pilot RCT (standard care, N=40 vs. DESA, N=40). Our primary hypothesis is that patients randomized to DESA will have a greater reduction in systolic BP (SBP) at 9 months than control patients. All patients will receive a BP Monitor that will capture, store and automatically transmit BP readings in real-time to a secure server via an encrypted cellular connection. Participants randomized to DESA will also receive a touch screen telehealth tablet with the necessary applications installed, and a cellular connection enabled. The third aim/ post-trial phase will solicit feedback via a survey and key informant interviews. The ultimate objective is to build capacity for a multidisciplinary research program and a robust, high-tech, community-engaged digital health solution that will synchronize data collection and data sharing across a network of community-based organizations, healthcare systems, and academic institutions.