Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County

NCT05641519 | Active Not Recruiting

• 2 other identifiers: 2835P50MD017366-04
• Study Type: interventional
• Target: 483
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Life's Essential 8; Social Networks; Community Health Workers; Hispanic/Latinx; Vietnamese

Outcome Measures

Primary Outcomes (4)

• Life's Essential 8

  To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.

  Baseline

• Life's Essential 8

  To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.

  1 year

• Life's Essential 8

  To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.

  2 year

• Life's Essential 8

  To evaluate the efficacy of family-based SERVE OC intervention versus ESI in achieving ""ideal" cardiovascular health as measured by Life's Essential 8 (LE8). LE8 is an assessment composed of 8 domains: smoking status, physical activity, weight, diet, sleep, blood glucose, cholesterol, and blood pressure (BP). LE8 scores can be calculated using the My Life Check portal from the American Heart Association. Having four or more ideal LE8 domains out of the total 8 domains will be considered 'ideal CVH'. The outcome is the number of LE8 domains that are ideal out of the total 8 domains.

  3 year

Secondary Outcomes (4)

• Systolic Blood Pressure

  Baseline

• Systolic Blood Pressure

  Year 1

• Systolic Blood Pressure

  Year 2

• Systolic Blood Pressure

  Year 3

Study Arms (2)

Enhanced Standard Intervention

PLACEBO COMPARATOR

Families randomized to enhanced standard intervention (ESI) will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care. At 12, 24, and 36 months they will be asked to return for in person follow-up to collect bio measures again and complete follow up surveys at the UCI FQHC in Santa Ana or during scheduled community data collection events. All adults will be asked to take their blood pressure with the device once a week.

Behavioral: Enhanced Standard Intervention

SERVE OC Intervention

EXPERIMENTAL

In the SERVE OC intervention, participants will receive AHA informational materials, access to the app/web portal, and will be assigned a CHW to work with over the 3 years of the study. The CHW will facilitate the intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations. All adults will be asked to take their blood pressure with the device once a week.

Behavioral: SERVE OC Intervention

Interventions

SERVE OC Intervention BEHAVIORAL

SERVE OC intervention for the family which includes 1) Conducting a family "intake" of risk factors through the LE8 assessment and discussing prevention/risk reduction 2) Facilitate the creation of a family network-tailored action plan 3) Provide guidance to activate/reinforce action plans using the interactive part of the app/web portal. They will meet with their CHW monthly to learn about CVH, work on their goals, and action plans. Meetings with CHWs will take place in their homes, the UCI FQHC in Santa Ana, over zoom, or other locations such as local churches, parks, community centers, or grocery stores (for field trips) They will also receive messages from them throughout the duration of the study using their preferred method of contact (text, email, webportal/app, phone call) for reinforcement and scheduling meetings

Also known as: Community Health Worker Intervention, Family Based Intervention

SERVE OC Intervention

Enhanced Standard Intervention BEHAVIORAL

Enhanced Standard Intervention will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care

Also known as: Usual Care, Standard of Care

Enhanced Standard Intervention

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in Santa Ana, Anaheim, Westminster or Garden Grove
• Speaks one of the languages in which the survey is administered in (English, Spanish, and Vietnamese)
• Aged \>=18 years old at time of enrollment
• Has 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 permission

You may not qualify if:

• Dementia history, cognitive impairment, or any condition impairing his/her ability to participate in education
• Life expectancy less than 1 year
• Unable to give informed consent or unable to obtain parent/guardian permission (minors)
• Lives in a nursing home or requires 24-hour care

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institutes of Health (NIH): collaborator
• Ohio State University: collaborator
• Latino Health Access: collaborator
• Vietnamese American Cancer Foundation: collaborator
• Radiate Consulting: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

Related Publications (1)

• Boden-Albala B, Draughter-Espinoza D, Castro M, Gutierrez D, Cardenas C, Landry MJ, Wing J, Albala B. Knowledge, barriers, and facilitators for promoting cardiovascular health in a Latino community: a qualitative sub-study of the Skills-based Educational Strategies for Reduction of Vascular Events in Orange County. Front Public Health. 2025 Jun 18;13:1531775. doi: 10.3389/fpubh.2025.1531775. eCollection 2025.

  PMID: 40606080 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bernadette Boden-Albala, DrPH, MPH

  UCI Program in Pubic Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Founding Dean, University of California Irvine Program in Public Health, Professor, Departments of Health, Society and Behavior (Program in Public Health) and Neurology (School of Medicine), Susan and Henry Samueli College of Health Sciences

Model Details: SERVE OC is a randomized controlled trial that utilizes block randomization, and the family/household will be the unit of randomization (participants in the same household will be randomized to the same intervention arm). We will prospectively enroll 150-200 households with school-age children from the SAC cohort and randomize the Hispanic/Latinx, Vietnamese, and non-Hispanic/ Vietnamese households to the SERVE OC intervention or enhanced standard intervention (ESI) to ensure balance between intervention arms within each race and ethnic group. Participant follow-up will occur at 12, 24, and 36 months.

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: December 7, 2022
• Study Start: November 18, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)