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Skills-Based Education for High Blood Pressure (SERVEOC Trial)
N/A
Recruiting
Led By Bernadette Boden-Albala, DrPH, MPH
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged >=18 years old at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 year
Awards & highlights
SERVEOC Trial Summary
This trial will test a culturally tailored program to help improve cardiovascular health for Latinx and Vietnamese families in Santa Ana, CA. It will focus on risk perception, provider communication and identifying challenges to cardiovascular health.
Who is the study for?
The SERVE OC trial is for Latinx and Vietnamese families in Santa Ana, CA, who are at least 18 years old or minors with an adult participant. They must live in specific areas, speak English, Spanish, or Vietnamese, and be able to give consent. Those with dementia or severe cognitive issues can't join.Check my eligibility
What is being tested?
This study tests a skills-based cardiovascular health intervention against an enhanced standard intervention over 36 months. It focuses on improving lifestyle factors related to heart health and blood pressure control using community health workers and digital tools.See study design
What are the potential side effects?
Since the interventions involve educational strategies rather than medications, there are no direct medical side effects expected from participating in this trial.
SERVEOC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
SERVEOC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Life's Essential 8
Secondary outcome measures
Systolic Blood Pressure
SERVEOC Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SERVE OC InterventionExperimental Treatment1 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.
Group II: Enhanced Standard InterventionPlacebo Group1 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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Who is running the clinical trial?
Ohio State UniversityOTHER
829 Previous Clinical Trials
504,635 Total Patients Enrolled
Latino Health AccessUNKNOWN
1 Previous Clinical Trials
3,780 Total Patients Enrolled
Radiate ConsultingUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English, Spanish, or Vietnamese.I am 18 years old or older.I am able to give informed consent or, if a minor, have permission from a parent/guardian.My child can join the study if they turn 5 within the next 3 years, with my permission.I live in a nursing home or need round-the-clock care.I do not have dementia or any condition that affects my ability to learn.You are expected to live for less than 1 year.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Standard Intervention
- Group 2: SERVE OC Intervention
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment actively seeking out participants?
"According to clinicaltrials.gov, this particular trial is no longer seeking participants at present. The posting date for the study was December 1st 2022 and it was last modified on November 30th of that same year. Despite not actively recruiting patients right now, there are still 749 other trials currently accepting volunteers."
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