Community Health Worker Support for High Blood Pressure

Overseen By Marta D Hansen, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Focus group participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how community health workers can assist people with high blood pressure (hypertension) in eating healthier and managing their condition, particularly for those facing food insecurity. Participants will either receive education on healthy eating and using local resources (CHW Education) or receive additional support such as grocery transport and cooking classes (CHW Education and Navigation). The trial aims to determine the practicality and helpfulness of these strategies for participants. It seeks individuals with diagnosed hypertension who experience food insecurity and live in specific zip codes. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could enhance community health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that programs led by community health workers (CHWs) are generally safe and well-received. Studies have found that CHWs often assist with health education and help manage high blood pressure. For example, a study in New York City found that these programs effectively controlled blood pressure without major safety issues.

Another study in China demonstrated that CHW-led programs reduced the risk of stroke in rural areas, with very few negative effects. This suggests that CHW interventions are not only effective but also safe for managing high blood pressure.

For the CHW Education and Navigation approach, evidence indicates that these programs improve access to healthcare resources. They effectively address high blood pressure with no significant safety concerns reported. These findings suggest that both the education and navigation components of CHW programs are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they empower individuals with high blood pressure through personalized community health worker (CHW) support. Unlike traditional methods that primarily depend on medication, these approaches emphasize education, motivation, and resource navigation to promote healthier lifestyle choices. The CHW Education arm focuses on teaching participants about healthy eating and utilizing benefits like SNAP and local food resources. Meanwhile, the CHW Education and Navigation arm goes further by offering personalized services such as transportation to grocery stores, virtual cooking classes, and practical shopping skills. This hands-on, personalized approach is a fresh take on managing high blood pressure, aiming to make a tangible difference in participants' lives by addressing real-world challenges.

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

Studies have shown that community health workers (CHWs) can greatly help patients control their blood pressure. One study found that 68.2% of patients in the CHW group achieved better blood pressure control compared to 41.6% in the group without CHW support. In this trial, participants in the CHW Education arm will receive education on healthier eating and resources like SNAP benefits. Meanwhile, the CHW Education and Navigation arm will offer additional personalized services such as transportation and cooking classes. These methods show promise in helping people maintain healthier blood pressure levels. ^{5 6 7 8 9}

Who Is on the Research Team?

Stephanie Staras, PhD

Principal Investigator

University of Florida

Carla Fisher, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure (130-179 mm Hg systolic and 80-119 mm Hg diastolic), who don't have enough food, are diagnosed with hypertension, live in specific zip codes (32609, 32601, or 32641), and qualify for SNAP benefits. Those who helped develop the intervention by participating in a focus group cannot join.

Inclusion Criteria

Your blood pressure is between 130/80 and 179/119.

You have trouble getting enough food to eat.

I have been diagnosed with high blood pressure.

Exclusion Criteria

Participated in a focus group to develop the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Participants complete baseline data collection including a behavior survey and baseline biometrics

1 week

1 visit (in-person)

Treatment

Participants are randomly assigned to one of three arms: no strategy, CHW education, or CHW education and navigation, and receive respective interventions

4 weeks

Weekly visits (in-person or virtual depending on arm)

Follow-up

Participants are monitored for changes in blood pressure and carotenoid levels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CHW Education
• CHW Education and Navigation

Trial Overview The study tests whether education from community health workers can help people eat more fruits and vegetables to lower their blood pressure. It's about finding out if this approach works well for those struggling to get enough food.

How Is the Trial Designed?

Group I: Community health worker provided education and Navigation Experimental Treatment 1 Intervention

Participants will be invited to complete all the CHW education arm material and be offered a menu of optional services for personalization including: (1) transportation to the grocery store (weekly for 4 weeks), (2) culturally adapted hypertension-tailored cooking recipes, (3) a virtual cooking class with food delivered to their door led by community partner, (4) access to UF IFAS's online library of healthy food cooking videos, and (5) in-store education on food labels, grocery shopping, and food resource management skills through the Cooking Matters at the Store curricula.

Group II: Community health worker provided education Experimental Treatment 1 Intervention

Participants will be invited to meet with the CHW to learn about eating healthier to reduce blood pressure and enhance quantity and quality of life. The CHW will register individuals for SNAP benefits and educate them on how to use their benefits locally. As other resources exist, including food pantries, food distribution events, and Fresh Access Bucks (a federal program to double SNAP if spent on local produce at eligible farmers markets), the CHW will provide information on these services. The CHW will also provide a brief motivational educational session about eating healthier to reduce BP and enhance quality and quantity of life. The CHW will meet once for up to one hour with each participant.

Group III: No strategy Active Control 1 Intervention

Individuals assigned to this arm with receive a publicly available color copy of the NIH's Healthy Blood Pressure for Healthy Hearts: Small Steps to Take Control Flyer available

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Community Health Workers (CHWs) who received enhanced training and support were 15% more likely to fully immunize their clients and 14% more likely to ensure that clients completed four or more antenatal care visits, indicating the effectiveness of the intervention in improving health outcomes.

The study found that recent training and experience with pregnant women significantly increased CHW knowledge, while education and literacy showed mixed associations with competency, suggesting that these factors may not be the best criteria for selecting CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. Rogers, A., Goore, LL., Wamae, J., et al.[2023]

Community health worker (CHW) interventions have proven effective in managing chronic diseases like hypertension, showing improvements in health outcomes and cost-effectiveness, particularly in emergency department (ED) settings.

Current CHW efforts in the ED focus on high-utilization patients, but more research is needed to explore their impact on broader community health outcomes beyond this 'super-user' population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers in the Emergency Department-Can they Help with Chronic Hypertension Care. Foster, B., Dawood, K., Pearson, C., et al.[2020]

Community health workers (CHWs) significantly improve care quality and health outcomes for chronic diseases, particularly hypertension, by enhancing access to care and treatment adherence among underserved populations.

CHWs play vital roles in patient education, monitoring health, and facilitating communication between patients and providers, but challenges remain in integrating them into healthcare teams effectively, requiring sustainable funding and policy changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. Brownstein, JN., Bone, LR., Dennison, CR., et al.[2022]

Community health worker (CHW) interventions in low- and middle-income countries have shown positive effects on reducing blood pressure, improving treatment adherence, and lowering cardiovascular disease risk among hypertensive patients and healthy individuals, based on a review of 14 studies.

The review highlighted that while CHW interventions were effective, the diversity in intervention types and outcomes prevented a meta-analysis, indicating a need for further research to assess the overall impact and cost-effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches and outcomes of community health worker's interventions for hypertension management and control in low-income and middle-income countries: systematic review. Mbuthia, GW., Magutah, K., Pellowski, J.[2023]

In a randomized controlled trial involving 421 participants with elevated blood pressure, enhanced tracking and follow-up services by community health workers significantly improved medical follow-up rates by 39.4% compared to usual care.

The intervention led to 65.1% of participants completing a follow-up visit within 90 days, compared to only 46.7% in the usual-care group, demonstrating the effectiveness of community health worker support in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. Krieger, J., Collier, C., Song, L., et al.[2019]

Community health workers (CHWs) play a crucial role in helping underserved populations manage hypertension by providing personalized support and addressing barriers to medication adherence, with an average of 8 visits per month lasting about 40 minutes each over 7 months.

The study highlights that CHWs work collaboratively with patients and healthcare providers, demonstrating their flexibility and patient-driven approach in improving hypertension self-management and communication between patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers as Allies in Hypertension Self-Management and Medication Adherence in the United States, 2014. Allen, CG., Brownstein, JN., Satsangi, A., et al.[2018]

A training program for community health workers (CHWs) focused on hypertension and diabetes management was successfully implemented for 12 Korean-American seniors, with all participants achieving a minimum knowledge level of 70%.

The training was well-received, with an average satisfaction rating of 9.3 out of 10, indicating that CHWs felt empowered in their roles, although further research is needed to assess the actual impact on health outcomes in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the training of Korean community health workers for chronic disease management. Han, HR., Kim, KB., Kim, MT.[2022]

A community health worker-led intervention significantly improved blood pressure control among participants in rural South India, with control rates increasing from 49.5% to 69.7% in the intervention group compared to a smaller increase from 52.2% to 61.7% in the usual care group.

The intervention also resulted in greater reductions in both systolic and diastolic blood pressure, indicating its efficacy in managing hypertension, while maintaining similar levels of medication use between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a scalable group-based education and monitoring program, delivered by health workers, to improve control of hypertension in rural India: A cluster randomised controlled trial. Gamage, DG., Riddell, MA., Joshi, R., et al.[2020]

Community health workers (CHWs) significantly improve blood pressure control in patients, as shown in seven out of eight randomized controlled trials (RCTs) reviewed, particularly among underserved urban African American populations.

CHWs also enhance self-management behaviors related to hypertension, such as medication adherence and appointment attendance, indicating their valuable role in multidisciplinary healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. Brownstein, JN., Chowdhury, FM., Norris, SL., et al.[2022]

Training nurse care managers (CMs) and community health workers (CHWs) significantly improved their confidence in addressing both medical and nonmedical factors contributing to uncontrolled hypertension in minoritized populations.

The collaborative care training curriculum was feasible and well-received, although challenges in teamwork arose from preexisting norms and beliefs among the CMs and CHWs, highlighting areas for future improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Combined Nurse Care Manager and Community Health Worker Training Curriculum to Address Hypertension Disparities. Alvarez, C., Ibe, C., Dietz, K., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8977767/

Approaches and outcomes of community health worker's ... Summarised outcomes of individual studies showed CHW enhanced the control and management of hypertension. Further studies are needed to indicate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9996176/

Unsung heroes in health education and promotion This study examines the outcomes of a hypertension focused CHW-led Self-Management Blood Pressure (SMBP) program operated by the University of ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.009900

Community Health Workers as Key Allies in the Global ... After 6 months at trial completion, BP control was superior in the CHW intervention (68.2%, n=154) compared with control (41.6%, n=137) group (P ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06230835

Community Health Worker Led Hypertension Prevention ... To measure the effectiveness (aim2), Investigators will use a cluster-randomized design to assess effectiveness in decreasing mean systolic BP ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.010396

Role of Health Care Professionals in the Success of Blood ... Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8101563/

A Community Health Worker–Led Intervention to Improve ... We analyzed the outcome of blood pressure (BP) control using pooled data from two community health worker interventions in New York City conducted between 2011 ...

7. ahajournals.org ahajournals.org/doi/10.1161/str.56.suppl_1.17

Abstract 17: The Effectiveness of a Community Health ... This study shows that a nonphysician health worker-led intensive BP control was effective at reducing stroke among rural residents in China.

8. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/jac5.70108

Outcomes of the Pharmacist and Community Health Worker ... This study highlights the effectiveness of a pharmacist-CHW cardiovascular clinic model in significantly improving blood pressure outcomes over ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556888/

Task-sharing with community health workers to treat ... In the identified 122 articles, CHWs often performed health education (61.3%) and measured blood pressure (60.4%). Whereas CHWs carried out pharmacological ...