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Recruiting
NCT05641519
Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County
Conditions: Hypertension
Sex: All
Ages: 5 Years – N/A
Phase: NA
Enrollment: 1000
Sponsor: University of California, Irvine
Location: United States
Summary
The Skills-Based Educational strategies for Reduction of Vascular Events in Orange County, CA (SERVE OC) study aims to evaluate the efficacy of a culturally tailored, skills-based, cardiovascular health (CVH) intervention amongst a cohort of Latinx and Vietnamese families in Santa Ana, CA.
The SERVE OC intervention was adapted from our previous work, the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) intervention, for the primordial prevention of hypertension (HTN) and other risk factors for cardiovascular disease (CVD).
(The DESERVE study was conducted at New York University under their IRB).
The intervention will be delivered by community health workers (CHWs) and will focus on: 1) optimizing risk perception, 2) enhancing provider-family communication, and 3) identifying challenges to CVH.
Participants will receive multi-lingual materials and access to an app/web portal to identify healthy goals and strategies around modifiable risk factors for CVH, Life's Essential 8. SERVE OC will follow participants for 36-months to examine changes in CVH using Life's Simple 7 (LS7): smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure (BP) scores and changes in systolic blood pressure (SBP) among adult participants versus enhanced standard intervention (ESI).
Remote blood pressure (BP) monitoring will also be used to assess BP over time.
CHWs will engage families in identifying barriers to CVH and solutions to share with community stakeholders.
Using this community-based research (CBPR) approach the investigators hope to improve health equity within the community through enhanced social capital, empowerment, and advocacy capacity.
This study is part of a multi-center projected coordinated by the UCLA-UCI Center for Eliminating Cardio-Metabolic Disparities in Multi-Ethnic Populations (UC END-DISPARITIES), aimed at improving CVH among underserved populations in Los Angeles and Orange County.
Eligibility Criteria
Inclusion Criteria:Living in Santa Ana in a randomly identified household (or living in Westminster or Garden Grove to achieve oversampling of Vietnamese families)Speaks one of the languages in which the survey is administered in (English, Spanish, and Vietnamese)Aged >=18 years old at time of enrollmentHas at least one friend/family/household member participating in the study with them, (if they are a minor they must have at least one adult participant participating with them)If child turns 5 during the 3 years of the study they will be eligible to participate and we will enroll them with parent permissionExclusion Criteria:Dementia history, cognitive impairment, or any condition impairing his/her ability to participate in educationLife expectancy less than 1 yearUnable to give informed consent or unable to obtain parent/guardian permission (minors)Lives in a nursing home or requires 24-hour care
Source: ClinicalTrials.gov (NCT05641519). StuddyBuddy aggregates publicly available trial information.