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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05641519
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : January 19, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Ohio State University
Latino Health Access
Vietnamese American Cancer Foundation
Radiate Consulting
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Bernadette Boden-Albala, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: SERVE OC Intervention Behavioral: Enhanced Standard Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County
Actual Study Start Date : November 18, 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arm Intervention/treatment
Placebo Comparator: Enhanced Standard Intervention
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
Enhanced Standard Intervention will be given informational materials from the American Heart Association on cardiovascular health. ESI includes self-management which is standard care
Other Names:
  • Usual Care
  • Standard of Care

Experimental: SERVE OC Intervention
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
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
Other Names:
  • Community Health Worker Intervention
  • Family Based Intervention




Primary Outcome Measures :
  1. Life's Essential 8 [ Time Frame: Baseline ]
    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. Life's Essential 8 [ Time Frame: 1 year ]
    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. Life's Essential 8 [ Time Frame: 2 year ]
    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.

  4. Life's Essential 8 [ Time Frame: 3 year ]
    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.


Secondary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: Baseline ]
    To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.

  2. Systolic Blood Pressure [ Time Frame: Year 1 ]
    To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.

  3. Systolic Blood Pressure [ Time Frame: Year 2 ]
    To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.

  4. Systolic Blood Pressure [ Time Frame: Year 3 ]
    To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Living in Santa Ana in a randomly identified household (or living in Westminster or Garden Grove to achieve oversampling of Vietnamese families)
  2. Speaks one of the languages in which the survey is administered in (English, Spanish, and Vietnamese)
  3. Aged >=18 years old at time of enrollment
  4. 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)
  5. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641519


Contacts
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Contact: Bernadette Boden-Albala, DrPH, MPH 949.824.5735 bbodenal@hs.uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Emily Drum, MPH    949-824-6553    edrum@hs.uci.edu   
Contact: Desiree Gutierrez, MPH    949-824-8091    dtgutier@hs.uci.edu   
Principal Investigator: Bernadette Boden-Albala, PhD         
Sponsors and Collaborators
University of California, Irvine
National Institutes of Health (NIH)
Ohio State University
Latino Health Access
Vietnamese American Cancer Foundation
Radiate Consulting
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Bernadette Boden-Albala, DrPH, MPH UCI Program in Pubic Health
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Responsible Party: Bernadette Boden-Albala, 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, University of California, Irvine
ClinicalTrials.gov Identifier: NCT05641519    
Other Study ID Numbers: 283
P50MD017366 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bernadette Boden-Albala, University of California, Irvine:
Hypertension
Life's Essential 8
Social Networks
Community Health Workers
Hispanic/Latinx
Vietnamese
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases