Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County (SERVEOC)
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ClinicalTrials.gov Identifier: NCT05641519 |
Recruitment Status :
Recruiting
First Posted : December 7, 2022
Last Update Posted : March 7, 2024
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Behavioral: SERVE OC Intervention Behavioral: Enhanced Standard Intervention | Not Applicable |
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 : | July 2026 |
Estimated Study Completion Date : | July 2026 |
Arm | Intervention/treatment |
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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.
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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:
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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.
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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:
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- 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.
- 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.
- 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.
- 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.
- Systolic Blood Pressure [ Time Frame: Baseline ]To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
- 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.
- 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.
- 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.
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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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Contact: Bernadette Boden-Albala, DrPH, MPH | 949.824.5735 | bbodenal@hs.uci.edu |
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 |
Principal Investigator: | Bernadette Boden-Albala, DrPH, MPH | UCI Program in Pubic Health |
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: | March 7, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Life's Essential 8 Social Networks |
Community Health Workers Hispanic/Latinx Vietnamese |
Hypertension Vascular Diseases Cardiovascular Diseases |