JMIR Publications

ABSTRACT

Background:

African Americans (AAs) experience higher rates of hypertension (HTN) and related cardiovascular and stroke mortality compared with the general U.S. population. Interestingly, studies have shown that AAs take more antihypertensive medications but are less likely to adhere to the prescribed medication regimens compared to the general population. Additionally, participants in qualitative studies have expressed that HTN self-management, particularly lifestyle modifications, should receive more attention than increasing medications.

Objective:

The objectives of this study are: 1) to evaluate the synergistic effect of a pharmacist and community health worker (Pharm+CHW) intervention compared to a Pharmacist alone (Pharm) to improve blood pressure (BP) outcomes in a predominantly AA cohort aged ≥ 55 years in a prospective randomized trial (n=480); 2) to identify factors correlated with clinical blood pressure outcomes.

Methods:

This is a randomized clinical trial to investigate novel behavioral intervention strategies targeting HTN self-management (e.g., medication management, blood pressure monitoring using a mobile health app) and lifestyle modifications. The study has two components: a pharmacist-led medication management component (Pharm) and a community health worker support component (CHW). In the Pharm component, pharmacists will provide virtual Medication Therapy Management (MTM) services, which include: a comprehensive medication review, recommendations for lifestyle modifications, and blood pressure self-monitoring education using an app. In the Pharm+CHW component, CHW will support participants’ self-initiation of behavioral change(s), address challenges to lifestyle modification, and provide health education through workshops. The study intervention will be guided by a Community Advisory Board (CAB) consisting of six members. The study will recruit a cohort of 480 predominantly AA adults 55 years or older with HTN through community-and faith-based organizations and clinics in Houston, Texas, U.S. Participants will be prospectively randomized to one of the two parallel groups: 1) Pharmacist alone (n=240); or 2) Pharmacist and CHW interventions (Pharm+CHW; n=240) for 24 months. Computer-generated randomization, with 1:1 allocation stratified by recruitment sites will be applied. The primary outcome is the change in self-monitoring BP readings over the 24-month trajectory, will be measured at 0-, 6-, 12-, 18-, and 24-months to evaluate the effectiveness of the proposed interventions using a mixed-effects model for repeated measures (MMRM). The secondary outcomes will include medication adherence, hypertension knowledge, perceived competency, body mass index, and physical activity.

Results:

Recruitment is ongoing, and the intervention is expected to begin in summer 2026.

Conclusions:

This project will fill an important knowledge gap regarding the synergistic effect of CHWs working in collaboration with pharmacists to help older adults use technologies (e.g., virtual visits, mobile health technologies) and initiate lifestyle modifications for HTN self-management in older adult AAs. Clinical Trial: ClinicalTrials.gov NCT07413159 https://clinicaltrials.gov/study/NCT07413159