Feasibility and acceptability of a multilevel, family-based hypertension self-management intervention for African American primary care patients: a pilot trial protocol

Background Significant disparities in hypertension outcomes experienced by African Americans are only partially ameliorated by existing lifestyle interventions, which largely fail to leverage family level strengths or address family level stress. Given African Americans living with hypertension regularly report friends, family, or kin as key to their disease self-management efforts, family-based interventions that are integrated into usual primary care and also address environmental barriers to self-management may be a particularly culturally attuned approach that is accessible and efficacious. We aim to evaluate the feasibility and acceptability of Walk Together, a community-informed dyadic intervention to promote hypertension self-management among African American primary care patients with uncontrolled hypertension via a single-arm pilot trial. Methods We will recruit African American, English-speaking primary care patients (18–75 years) with an essential hypertension diagnosis and 2 past-year clinic-based blood pressure measurements of > 130/ > 80 mmHg ( n = 30). Patients with a diagnosed severe psychiatric condition, current suicidality, cognitive impairment, or prior engagement in an onsite hypertension clinic will be excluded. Patients will self-identify an English-speaking family support person (aged 18–75) who is involved in their daily care and helps them manage their hypertension to participate with them ( n = 30). All enrolled patient participants will receive a home blood pressure monitor and a cellular-enabled study iPad. Patients and family support persons will participate in four dyadic study sessions across 2 months to promote hypertension knowledge, maximize family support, address family stress, and target environmental barriers to self-management via preexisting healthcare system resources. The primary outcomes of the trial will be feasibility, including accrual (recruitment 30 dyads in 11 months), adherence (proportion of dyads completing four intervention components and proportion completing post-treatment assessments), and attrition (> 20% of participants dropping out of the study protocol), and acceptability (participant reports of satisfaction). Discussion Results will provide evidence of the feasibility and acceptability of a multilevel family-based hypertension self-management intervention developed via community-based participatory input at each phase of intervention design to inform future efficacy trials. Trial registration NCT05671302 Walk Together: A Family-Based Intervention for Hypertension in African Americans, first posted January 2nd, 2023; last update posted April 9th, 2024.