Skills-Based Education for High Blood Pressure

(SERVEOC Trial)

Overseen By Bernadette Boden-Albala, DrPH, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Dementia, Cognitive impairment, Nursing home, others

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a skill-based, culturally tailored education program, called the SERVE OC Intervention, can help Latinx and Vietnamese families in Santa Ana improve heart health and prevent high blood pressure. Participants will receive support from community health workers, educational materials, and access to an app to set and track health goals. The trial seeks to assess whether this approach can better manage factors like diet, exercise, and blood pressure over three years compared to standard information alone. It is suitable for adults living in Santa Ana and nearby cities who speak English, Spanish, or Vietnamese and have a friend or family member joining them.

As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and receive personalized support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on education and lifestyle changes rather than medication adjustments.

What prior data suggests that this skills-based educational intervention is safe for cardiovascular health?

Research has shown that educational programs like the SERVE OC program are generally safe. These programs focus on teaching skills and improving lifestyle habits, avoiding the risks associated with medication or surgery. Previous studies, such as the DESERVE program on which SERVE OC is based, have identified no safety concerns with these educational initiatives.

In fact, studies have demonstrated that these programs can help people manage their health effectively. For instance, one study found that a structured program helped participants lower their blood pressure. This suggests that the SERVE OC program is likely safe and well-received by participants. No evidence indicates harmful effects, making it a promising option for those seeking to improve heart health without medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SERVE OC Intervention for high blood pressure because it takes a fresh, holistic approach by involving Community Health Workers (CHWs) who personalize and guide families through creating and following a tailored action plan. Unlike traditional treatments that focus solely on medication or lifestyle advice, this intervention uses a combination of technology and personal support, enabling participants to actively engage with their cardiovascular health goals. With monthly meetings and digital tools, it aims to empower participants to make sustainable lifestyle changes, potentially leading to long-term improvements in managing hypertension.

What evidence suggests that this trial's interventions could be effective for high blood pressure?

Research has shown that community programs can effectively lower blood pressure. A review of 34 studies found that these programs reduced the systolic blood pressure by an average of 7.26 mmHg. This trial will compare two approaches: the SERVE OC Intervention and the Enhanced Standard Intervention. The SERVE OC program includes personalized care, education, and lifestyle changes as key components. Digital tools focusing on lifestyle changes also aid in improving blood pressure control. Overall, evidence suggests that the skills-based approach used in SERVE OC can enhance heart health among participants. ^{3 6 7 8 9}

Who Is on the Research Team?

Bernadette Boden-Albala, DrPH, MPH

Principal Investigator

UCI Program in Pubic Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Living in Santa Ana in a randomly identified household (or living in Westminster or Garden Grove to achieve oversampling of Vietnamese families)

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)

My child can join the study if they turn 5 within the next 3 years, with my permission.

Exclusion Criteria

I am able to give informed consent or, if a minor, have permission from a parent/guardian.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments include bio-measure assessment and surveys on diet, physical activity, sleep, vascular health, socio-demographics, and health equity measures

1-2 weeks

Intervention

Participants receive the SERVE OC intervention or Enhanced Standard Intervention (ESI) with monthly meetings and ongoing support

36 months

Monthly meetings with CHWs, annual follow-up visits

Follow-up

Participants are monitored for changes in cardiovascular health and systolic blood pressure

36 months

Follow-up visits at 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Standard Intervention
• SERVE OC Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: SERVE OC Intervention Experimental Treatment 1 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 Intervention Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Latino Health Access

Collaborator

Trials

2

Recruited

4,300+

Radiate Consulting

Collaborator

Trials

1

Recruited

480+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Vietnamese American Cancer Foundation

Collaborator

Trials

1

Recruited

480+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Community-based programs have been effective in raising awareness and promoting healthier behaviors to control high blood pressure, emphasizing partnerships and resident involvement in screening and education.

Utilizing trained community health workers to deliver culturally sensitive education on heart health has been shown to enhance the effectiveness of these programs, potentially leading to better blood pressure management in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of community programs in controlling blood pressure. Fulwood, R., Guyton-Krishnan, J., Wallace, M., et al.[2019]

Patient education is crucial in managing high blood pressure, requiring healthcare providers to assess individual patient needs and create tailored care plans.

Effective educational strategies can improve patient engagement and adherence to treatment, leading to better blood pressure control and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for patient education. Hill, MN.[2019]

A five-year study involving 400 urban poor hypertensive patients showed that health education interventions significantly improved compliance with treatment and blood pressure control, leading to better health outcomes.

The experimental group experienced a 57.3% reduction in all-cause mortality and a 53.2% reduction in hypertension-related mortality compared to the control group, highlighting the long-term benefits of these educational programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year blood pressure control and mortality following health education for hypertensive patients. Morisky, DE., Levine, DM., Green, LW., et al.[2019]

The Hypertension Diet Education Program successfully trained practical nurses to provide culturally relevant nutritional counseling, leading to significant improvements in their knowledge and skills.

Among the patients counseled, 63% achieved controlled blood pressure readings within eight months, demonstrating the program's effectiveness in managing hypertension through dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hypertension diet education program for public health nurses. Kostas, G.[2009]

A study involving 380 Korean American individuals with hypertension found that both mailed and in-class culturally tailored education interventions significantly reduced blood pressure, with systolic BP reductions of 13.3 mm Hg and 16.1 mm Hg, respectively.

Both intervention groups achieved similar improvements in blood pressure control rates, indicating that mailed education can be as effective as in-class sessions, making it a practical option for busy individuals and other immigrant populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mail education is as effective as in-class education in hypertensive Korean patients. Kim, MT., Kim, EY., Han, HR., et al.[2022]

Citations

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Effectiveness of team-based care interventions in improving ... We evaluated the effectiveness of team-based care interventions in improving blood pressure (BP) outcomes among adults with hypertension in Africa.

2. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000249

2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ ... The focus of this clinical practice guideline is to create a living, working document updating current knowledge in the field of high blood ...

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Integrating a High Blood Pressure Advisory Across ... This quality improvement study of an EMR high BP advisory intervention found significantly improved primary care hypertension control and diagnosis.

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-24283-x

Assessing Community-Based interventions effectiveness on ... Meta-analysis results of 34 studies showed that the interventions reduced the mean systolic blood pressure by 7.26 mmHg [5.32–9.2, CI = 95%] and ...

5. nature.com nature.com/articles/s41371-025-01051-3

A systematic review and meta-analysis of digital ... Digital interventions targeting lifestyle factors were associated with an improvement in blood pressure in patients with hypertension, but ...

6. publichealth.uci.edu publichealth.uci.edu/2024/02/13/family-based-heart-health/

Family-based heart health According to Boden-Albala, Serve OC aims to scale up its intervention over the next five years based on positive data outcomes. Findings ...

7. cdph.ca.gov cdph.ca.gov/Programs/CCDPHP/DCDIC/CDCB/Pages/HealthyHeartsCalifornia.aspx

Healthy Hearts California - CDPH - CA.gov Goal 1A: By 2023, decrease the prevalence of high blood pressure from 25 percent to 24 percent. Goal 1B: By 2023, increase the percentage of ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK220091/

Interventions Directed at Individuals with Hypertension - NCBI A Framingham study found that only 33 percent were controlled to a systolic blood pressure goal, whereas 83 percent were controlled to a diastolic blood ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1717250

A Cluster-Randomized Trial of Blood-Pressure Reduction ... A blood-pressure level of less than 130/80 mm Hg was achieved among 63.6% of the participants in the intervention group versus 11.7% of the ...