75 Participants Needed

Community Health Worker Support for High Blood Pressure

SA
MD
Overseen ByMarta D Hansen, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The overall objective of this project is to assess the feasibility, acceptability, and appropriateness of adapted community health worker (CHW)-led implementation strategies designed to improve intake of fruits and vegetables and reduce BP among patients with hypertension experience food insecurity.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment CHW Education, CHW Education and Navigation for high blood pressure?

Research shows that community health workers (CHWs) are effective in improving care and health outcomes for chronic diseases like high blood pressure. They help by educating patients, providing counseling, and ensuring patients follow their treatment plans, which leads to better blood pressure control.12345

Is Community Health Worker support for high blood pressure safe for humans?

Community Health Worker programs have been used safely to help manage chronic diseases like high blood pressure and diabetes, especially in underserved communities. These programs focus on education, support, and improving access to care, and there is no evidence suggesting they are unsafe for humans.12678

How does the Community Health Worker Support treatment for high blood pressure differ from other treatments?

This treatment is unique because it involves community health workers (CHWs) who provide education and navigation support to help manage high blood pressure. CHWs play a crucial role in improving access to care, enhancing communication between patients and healthcare providers, and addressing social factors that affect health, which is different from traditional medical treatments that focus solely on medication.124910

Research Team

CF

Carla Fisher, PhD

Principal Investigator

University of Florida

SS

Stephanie Staras, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

Participated in a focus group to develop the intervention

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Community health worker provided education and NavigationExperimental Treatment1 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 educationExperimental Treatment1 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 strategyActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Community Health Workers in the Emergency Department-Can they Help with Chronic Hypertension Care. [2020]
Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]
Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. [2019]
Development and Implementation of a Combined Nurse Care Manager and Community Health Worker Training Curriculum to Address Hypertension Disparities. [2023]
Approaches and outcomes of community health worker's interventions for hypertension management and control in low-income and middle-income countries: systematic review. [2023]
Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. [2023]
Evaluation of the training of Korean community health workers for chronic disease management. [2022]
Community Health Workers as Allies in Hypertension Self-Management and Medication Adherence in the United States, 2014. [2018]
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. [2020]
Effectiveness of community health workers in the care of people with hypertension. [2022]
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