University of California, Irvine
Irvine, California, 92697, United States
NCT Number: NCT05641519
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.
This study is active but is not currently recruiting participants.
Notify Me5 year and older
All sexes
Interventional
Not applicable
Irvine, California, 92697, United States
a. CHWs: CHWs will be UCI affiliated. All CHWs will be added to the research personnel tracking log. Over the 3 years of the study, the CHWs will interact with families in their home, or at community sites depending on the family's preference. They will encourage family level activities to improve CVH using interactive curriculums, narrative videos, informational workbooks (available in Spanish, Vietnamese, or English), the web portal/app, and reinforcement. They will ask families to identify barriers to improving CVH and possible solutions to utilize later for SERVE OC community activities. CHWs will also respond to other issues families may have including poverty, food insecurity, domestic abuse, and substance misuse. After 1 year, the team will incorporate relevant educational materials and protocols into the intervention to help CHWs respond to these issues and to provide families with resources.
App/Web portal: For SERVE OC, the existing FURRThERhealth.com interactive web portal/app which was used in previous studies will be updated for the needs of the SERVE OC intervention. The web portal will facilitate the creation of tailored action plans, including setting goals and planning activities; allow groups to track activities and earn stars and trophies for their accomplishments; facilitate online communication in preferred languages; and provides curated AHA and other resources to support primary and secondary prevention. During the initial meeting, the CHW will introduce the portal to families. Each individual will be assigned a unique profile with corresponding avatar handle that is linked to their identifying information. With the CHW, the login process and site functionality will be demonstrated to all members of the group. Tech support information will be made available. There are 2 sections of the web portal: 1) the resource section and 2) the facilitated network engagement (goal creation, activity tracking, chat and photo sharing, push notifications and e-messages). The CHW will work with the families to enter chosen goals and activities into the portal and demonstrate the process of tracking activity completion. After goal setting, families will start to receive push messages about working together on healthy lifestyle and risk reduction. The initial messages focus on support for the transition to engaging in healthy lifestyles as a family. The investigators anticipate that there will be changes to goals and times when networks go into holding patterns (no activity or motivation). Messages from SERVE OC will change to address new barriers and challenges.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
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.
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.
Time frame: Baseline
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
Time frame: Year 1
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
Time frame: Year 2
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
Time frame: Year 3
To examine the effect of SERVE OC intervention versus ESI in changing systolic blood pressure (SBP) among adults.
University of California, Irvine
Other
Acronym: SERVEOC
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