Optimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP) Intervention Versus Waitlisted Group in African American Adults with Hypertension: A Randomized Control Trial Protocol

Carolyn Harmon Still,1 Carla Harwell,2 Cheryl Killion,1 Abdus Sattar,3 Satish E Viswanath4 1Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, 44106, USA; 2Department of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA; 3Department of Population and Quantitative Health Sciences, School of Medicine, Case Western Reserve University, Cleveland, OH, 44106, USA; 4Department of Biomedical Engineering, School of Medicine, Case Western Reserve University, Cleveland, OH, 44106, USACorrespondence: Carolyn Harmon Still, The Kate Hanna Harvey Professor of Community Health Nursing, Frances Payne Bolton School of Nursing, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, Ohio, 44106, USA, Tel +216 368 6338, Email [email protected]: Consistent adherence to prescribed hypertension treatment regimens is an important goal for persons living with hypertension, yet it remains a challenge for minority and underserved populations. Employing technology-based intervention (TBI) to support self-managing hypertension presents an opportunity to effectively control blood pressure (BP), and potentially have long-term effects on health outcomes.Objective: The objective of this study is to test the efficacy of a TBI, OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP), as an approach to support hypertension self-management to improve BP, health-related quality of life (HRQOL), and long-term compliance in African Americans with hypertension.Methods: This prospective, 2-arm randomized trial conducted in the Midwest will enroll African American older adults with hypertension, 50 years of age and older, recruited from primary clinics and community settings. Participants are allocated in a 1:1 ratio using computer-generated randomization to OPTIMA-BP intervention (n = 104) or Waitlist control group (n = 104). Participants are asked to participate in the study over a 12-month period and complete 5 study visits. Individuals in the OPTIMA-BP intervention group will receive three technology components (web-based education, medication adherence mHealth app, study provided home BP monitor), coupled with nurse counselling and communication to providers for guideline-directed treatment regimen. We will also collect data on knowledge-attitude mechanisms of self-management (hypertension knowledge, self-efficacy, perceived social support) and proximal behavioral mechanisms (antihypertension medication-taking, diet, exercise). Qualitative analyses will explore participants’ experiences with self-managing hypertension using technology.Results: Participant recruitment began in March 2022, and is currently ongoing. It is anticipated that preliminary findings appropriate for analysis will be disseminated in Summer 2025. The primary endpoint is a change in BP (< 130/80 mmHg) and improved HRQOL.Conclusion: Using TBI along with standard preventive measures provides a unique opportunity to improve BP control and enhance secondary cardiovascular disease prevention in this high-risk group.Trial Registration: ClinicalTrials.gov NCT05564728; https://clinicaltrials.gov/study/NCT05564728.Keywords: tech-based intervention, hypertension, self-management, African Americans, older adults, self-efficacy