Abstract Body: Background: Effective interventions to lower blood pressure (BP) after stroke are needed, especially for vulnerable populations such as Black individuals and those with post-stroke disability. The TEAMS-BP trial is designed to compare the effectiveness of two evidence-based interventions among stroke survivors with uncontrolled BP.
Methods: The Telehealth Enhanced Assessment and Management after Stroke-BP (TEAMS-BP) trial compares Intensive Clinic Management (ICM, in-person medical management with home BP monitoring via daily paper logs and health promotion messaging) vs Intensive Tailored Telehealth Management (ITTM, digital transmission of BP and physical activity, medical management via telehealth, and health coaching) to achieve SBP control (<130 mm Hg). Feasibility outcomes included rates of consent, follow-up, and adherence to study procedures in addition to 3-month BP control and participant experience.
Results: Overall, 608 cases were ascertained from 10/1/2022 to 6/1/2023. Of these, 474 (78%) pre-screened eligible, 264 (54%) were invited to participate, and 31% consented (Figure 1). Consent rates varied by demographics (33% Black, 26% non-Black; 14% age 75+, 34% <75). Fifty participants from 3 sites were randomized to three months of ICM or ITTM (50% female, 32% Black, 60% with disability, mean age 66 years [SD 9.9]). Participant adherence to protocol-specified provider visits and coaching sessions was high (Figure 2). The 3-month follow-up rate was 90% (22 of 26 ITTM, 23 of 24 ICM). Fifty-five percent achieved the 3-month target SBP, and the 3-month change in SBP was -10.2 (18.4). Ninety percent of participants reported an excellent experience with the study.
Discussion: The randomization rate was lower than projected despite expected consent rates. This feasibility study achieved consent, follow-up, and adherence targets for race and disability subgroups but not age. As one of the first Phased Large Awards for Comparative Effectiveness Research (PLACER), these feasibility data informed the main trial design, refinement of the interventions and data collection, and identified opportunities for improving recruitment. Study adherence was excellent, supporting patient acceptance and feasibility of the main trial.