Abstract
BACKGROUND: Hypertension is the leading risk factor for cardiovascular disease (CVD). Despite advances in blood pressure management, significant racial and ethnic disparities persist, resulting in higher risks of stroke, heart disease, and mortality among non-White populations. Self-measured blood pressure (SMBP) monitoring, also known as home blood pressure monitoring, has shown promise in improving blood pressure control, especially when combined with feedback from healthcare providers. However, the adoption of SMBP remains low, particularly among racial and ethnic minorities, due to various patient, provider, and system-level barriers. OBJECTIVES: This study aims to evaluate the feasibility of study methods implementing the ASPIRE (adapting self-measured blood pressure to reduce health disparities) toolkit in a primary care setting. The toolkit is designed to address barriers to SMBP adoption and improve hypertension management among underserved populations to increase SMBP adoption. METHODS: This pilot hybrid effectiveness-implementation randomized controlled trial (RCT) will be conducted at a primary care clinic in South Side Chicago, serving a diverse patient population. Eligible patients with uncontrolled hypertension will be randomized to either the intervention group, receiving the ASPIRE toolkit and support, or the control group, receiving usual care. The primary outcomes include feasibility measures including recruitment rates, attrition, and availability of data in the electronic health records. RESULTS: The feasibility of the study methods will be analyzed to inform a larger multi-site RCT informed by progression criteria developed in this protocol. Qualitative interviews with patients and providers will explore the appropriateness and implementation success of the toolkit using the Consolidated Framework for Implementation Research (CFIR). CONCLUSIONS: This pilot RCT will provide critical insights into the feasibility of study methods to evaluate the implementation success of the ASPIRE toolkit in a real-world primary care setting. By addressing barriers to SMBP adoption, this intervention has the potential to improve hypertension management and reduce health disparities in underserved populations. TRIAL REGISTRATION: NCT: NCT06175793. Registered 19 December 2023, https://clinicaltrials.gov/study/NCT06175793 .