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Clinical Trial Summary

Black adults have a higher incidence of hypertension (HTN) and a greater risk of HTN-related cardiovascular disease (CVD) compared with White adults. Even mild elevations in blood (BP) above 115/75 mm Hg are associated with increased CVD risk. Accordingly, emphasis is being placed on early interventions for high BP, particularly in those who have "elevated BP" (systolic BP 120-129 and diastolic BP < 80 mm Hg), for participants lifestyle modification is recommended. Although lifestyle modifications are effective to lower BP, implementation is suboptimal in Black communities, especially those participants residing in low-income urban settings. Pervasive negative social determinants of health (SDoH), such as poor access to healthcare, food insecurity, limited availability of healthy foods, lack of safe places to engage in physical activity, and low health literacy are major drivers of inequities in HTN and a critical barrier to implementation of recommended lifestyle modifications in Black communities. To achieve health equity, effective strategies must address negative SDoH that are root causes of racial disparities in health outcomes as clearly demonstrated by the coronavirus disease (COVID-19) pandemic. Predominantly Black cities like Detroit, Michigan, where the mortality rate from heart disease is nearly twice the national average, have been devastated by COVID-19. To address this, the investigators developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to direct deployment of testing and vaccination services to communities with highest needs. Since April 2020, the investigators conducted 500 events with 220 community partners where 40,000 people have been tested or vaccinated for COVID in MHUs. Using a hybrid type I effectiveness-implementation design in the proposed Linkage, Empowerment, and Access to Prevent Hypertension (LEAP-HTN) study, the investigators will implement a novel approach that links Black adult participants with elevated BP to collaborative care delivered in deprived neighborhoods by community health workers (CHWs) using a personalized, adaptable approach to lifestyle and life circumstance (PAL2) intervention. The investigators will leverage our MHU program, layering on top of existing services to streamline access for screening, recruitment and all ongoing follow-up throughout the study period. Our specific aims are: AIM 1: To compare the effect of PAL2 intervention versus usual care (MHU engagement without PAL2) on BP reduction and prevention of stage-1 HTN among 500 Black adults with elevated BP. Systolic BP (primary outcome) will be reduced more in those randomized to PAL2 intervention versus usual care at 6 and 12 months. Diastolic BP levels and the incidence of stage-1 HTN at 12 months (secondary outcomes) will be lower in participants randomized to the PAL2 intervention versus usual care. AIM 2: To use the RE-AIM framework to assess the reach, adoption, sustainability and cost-effectiveness of LEAP-HTN at 12 months and 24 months post-randomization. The rates of adoption and sustainability of the PAL2 intervention will increase from baseline to 12 and 24 months, respectively. PAL2 intervention will be more cost-effective than usual care at 24 months and projected to be more cost-effective at 10 years. Health Equity Impact: Targeted deployment of MHUs and PAL2 can mitigate several key adverse SDoH. LEAP-HTN contributes to the RESTORE Network by testing a sustainable and scalable approach to advance health equity and prevent HTN in Black adults participants. If successful, the use of MHU can be easily implemented in similar urban Black communities across the U.S.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05061108
Study type Interventional
Source Wayne State University
Contact Phillip Levy, MD
Phone 313-577-1214
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 1, 2022
Completion date September 30, 2025

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