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

483 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Enhanced Standard Intervention, SERVE OC Intervention for high blood pressure?

Educational programs and structured behavioral education have shown positive effects on blood pressure control and patient adherence to treatment, as seen in studies where such interventions led to better blood pressure management and reduced mortality rates. ^{1 2 3 4 5}

Is the Skills-Based Education for High Blood Pressure treatment safe for humans?

Research on similar educational interventions for high blood pressure shows they are generally safe, with no adverse psychological effects reported and increased motivation without increased anxiety. ^{3 6 7 8 9}

How is the SERVE OC Intervention treatment different from other treatments for high blood pressure?

The SERVE OC Intervention is unique because it focuses on skills-based education to help patients manage high blood pressure, emphasizing patient education and active participation. Unlike traditional medication-based treatments, this approach involves teaching patients practical skills and strategies to control their blood pressure through lifestyle changes and self-management. ^{3 10 11 12 13}

Research Team

Bernadette Boden-Albala, DrPH, MPH

Principal Investigator

UCI Program in Pubic Health

Eligibility Criteria

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

I speak English, Spanish, or Vietnamese.

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Five-year blood pressure control and mortality following health education for hypertensive patients. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Brief provider communication skills training fails to impact patient hypertension outcomes. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Educational interventions for improving control of blood pressure in patients with hypertension: a systematic review protocol. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Constructing and testing a self-help intervention program for high blood pressure control in Korean American seniors--a pilot study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Influencing adherence among hypertensives. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Keep on track: a volunteer-run community-based intervention to lower blood pressure in older adults. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

A Health Literacy-Focused Intervention for Latinos with Hypertension. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Education for Hypertensive Patients with Correctly Performed Self-Blood Pressure Monitoring (SBPM). [2023]

9. England pubmed.ncbi.nlm.nih.gov

Education of the hypertensive patient: the Ann Arbor approach. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Role of community programs in controlling blood pressure. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

Strategies for patient education. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Mail education is as effective as in-class education in hypertensive Korean patients. [2022]