Remote BP Management + Community Health Workers for High Blood Pressure

(PRESSURE CHECK Trial)

Recruiting at 3 trial locations

Overseen By Jocelyn Dorney, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pregnancy, End stage renal disease, Chemotherapy

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

Compensation: Varies

Number of Visits: 30

1440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the use of community health workers and remote blood pressure management safe for humans?

Research shows that community health workers (CHWs) are effective in improving care for chronic diseases like high blood pressure, and they help people access and stick to their treatment. There is no specific mention of safety concerns, suggesting that these interventions are generally considered safe for humans. ^{1 2 3 4 5}

How is the Community Health Worker treatment for high blood pressure different from other treatments?

The Community Health Worker (CHW) treatment is unique because it involves trained local health workers who provide culturally relevant education and support to help manage high blood pressure, especially in resource-poor settings. This approach focuses on community-based education and monitoring, which can improve blood pressure control by increasing awareness and adherence to treatment among patients. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Remote BP Management + Community Health Workers for High Blood Pressure?

Research shows that community health workers (CHWs) are effective in helping people manage high blood pressure, especially in low-resource settings. They provide education, support, and follow-up, which helps people make lifestyle changes and improve their blood pressure control. ^{3 4 6 7 10}

Who Is on the Research Team?

Rafael Perez-Escamilla, MD

Principal Investigator

Yale University

Erica Spatz, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with high blood pressure, specifically those who have an average resting BP of >=135/85 mmHg based on three consecutive readings. It's not suitable for people who don't meet this BP threshold.

Inclusion Criteria

Elevated BP, defined as an average resting BP of >=135/85 mmHg based on 3 consecutive blood pressure readings

Exclusion Criteria

I am on dialysis for end-stage kidney disease.

People who are pregnant

I am currently undergoing chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care

Participants will be monitored prior to any RBPM intervention

6 months

Baseline, 6, 12, and 18 months

Remote Blood Pressure Management Program

Participants receive a remote BP management program inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist

6 months

Baseline, 6, 12, and 18 months

Remote Blood Pressure Management Program + Community Health Worker

Participants receive a remote BP management program with home BP monitoring, telehealth visits, and support from a community health worker

6 months

Baseline, 6, 12, and 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

12 and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker (CHW)
• Remote Blood Pressure (BP) Management Program (RBPM)

Trial Overview The study is testing two approaches to manage high blood pressure outside the hospital: one uses a remote BP management program (RBPM), and the other combines RBPM with support from a community health worker (CHW).

How Is the Trial Designed?

Group I: Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW) Experimental Treatment 2 Interventions

Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist plus a social model with a CHW.

Group II: Usual Care Active Control 1 Intervention

Participants receive education about hypertension and are referred to primary care for ongoing management.

Group III: Remote Blood Pressure (BP) Management Program Active Control 1 Intervention

Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

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]

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]

The Community Health Worker (CHW) led Self-Management Blood Pressure (SMBP) program significantly improved hypertension management in rural communities by providing education, resources, and support, helping participants develop lifelong healthy habits.

Participants in the SMBP program reported better health outcomes, including improved blood pressure management, due to the CHWs' role in bridging gaps between healthcare providers and the community, fostering a supportive environment for lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsung heroes in health education and promotion: How Community Health Workers contribute to hypertension management. Bush, K., Patrick, C., Elliott, K., et al.[2023]

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 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]

The COBRA-BPS hypertension management program was found to be acceptable to key stakeholders, including community health workers, physicians, and patients across Bangladesh, Pakistan, and Sri Lanka, indicating strong support for its implementation.

Most stakeholders expressed enthusiasm for the program, although patients highlighted the need for consistent access to free medications, suggesting that addressing supply issues could enhance the program's effectiveness and acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-intervention acceptability of multicomponent intervention for management of hypertension in rural Bangladesh, Pakistan, and Sri Lanka- a qualitative study. Jafar, TH., Tavajoh, S., de Silva, HA., et al.[2023]

In a study involving 11,105 individuals across urban slums in Chhattisgarh, equipping community health workers (CHWs) to measure blood pressure significantly increased hypertension screening rates from 37.9% to 80.2%.

The intervention also improved treatment adherence, with 70.3% of diagnosed hypertension cases in the intervention group taking their complete medication compared to 55.1% in the comparison group, highlighting the effectiveness of CHWs in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of community health workers on improving identification and primary care of hypertension among the urban poor - findings from Chhattisgarh state of India. Garg, S., Dewangan, M., Nanda, P., et al.[2023]

A study involving 105 rural high-risk adults showed that a Community Health Worker (CHW) intervention significantly reduced blood pressure and body weight, indicating its effectiveness in managing cardiovascular disease risk factors.

Participants experienced a mean reduction of 5.4 mmHg in systolic blood pressure and 3.8 lbs in body weight after receiving 80% of the planned intervention visits, demonstrating the potential of CHWs in improving health outcomes in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study. Samuel-Hodge, CD., Gizlice, Z., Allgood, SD., et al.[2022]

Citations

1. England 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. [2023]

2. United States 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. [2019]

3. United States 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. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of people with hypertension. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Unsung heroes in health education and promotion: How Community Health Workers contribute to hypertension management. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]

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

Community Health Workers in the Emergency Department-Can they Help with Chronic Hypertension Care. [2020]

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

Post-intervention acceptability of multicomponent intervention for management of hypertension in rural Bangladesh, Pakistan, and Sri Lanka- a qualitative study. [2023]

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

Impact of community health workers on improving identification and primary care of hypertension among the urban poor - findings from Chhattisgarh state of India. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study. [2022]