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 trial aims to identify the best strategies for managing high blood pressure. It tests two methods: managing blood pressure remotely with home monitoring and telehealth, and adding support from a community health worker (CHW) who assists with social needs. These methods are compared to usual care, where individuals receive information about high blood pressure and visit their regular doctor. For those with high blood pressure, measured at 135/85 mmHg or higher, this trial might be suitable. As an unphased trial, it offers a unique opportunity to explore innovative management strategies for high blood pressure.

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.

What prior data suggests that these strategies are safe for managing high blood pressure?

Research has shown that managing blood pressure from home is generally safe. Programs using home monitoring and online doctor visits help control high blood pressure without major safety concerns. One study found that participants in these programs achieved better blood pressure control without serious side effects.

Adding a community health worker (CHW) to the program is also safe. Research indicates that CHWs can assist in managing blood pressure without causing harm. They often improve patient outcomes by providing extra support and guidance.

Overall, both home monitoring and the addition of a CHW are well-tolerated. Studies have shown no significant issues, making them promising options for safely managing high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote Blood Pressure (BP) Management Program with Community Health Workers (CHWs) because it combines technology with community support in a unique way. Unlike the usual care, which mainly involves education and referrals, this approach includes regular home BP monitoring and telehealth visits, ensuring more consistent tracking and management. The addition of CHWs provides a social support model, potentially increasing patient engagement and adherence to management plans. This combination of remote monitoring and community support could lead to better outcomes for those with high blood pressure, making it a promising option compared to traditional methods.

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

Research has shown that home-based blood pressure management programs, which include self-monitoring and online doctor visits, effectively improve blood pressure control. Studies have found that these programs help maintain blood pressure over time. In this trial, participants may join a Remote Blood Pressure (BP) Management Program, which includes home BP monitoring and telehealth visits.

Additionally, community health workers (CHWs) have successfully helped people better control their blood pressure. For example, programs led by CHWs significantly lowered participants' blood pressure compared to regular care. In this trial, some participants will receive a combination of the Remote BP Management Program and support from a CHW. Together, these methods aim to provide a comprehensive plan for effectively managing high blood pressure. ^{2 4 6 7 8}

Who Is on the Research Team?

Erica Spatz, MD

Principal Investigator

Yale University

Rafael Perez-Escamilla, 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 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]

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]

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]

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]

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]

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 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]

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]

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]

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

Approaches and outcomes of community health worker's ... The CHW interventions were mainly community-based and focused on behaviour change for promoting BP control among hypertensive patients as well as healthy ...

2. ahajournals.org ahajournals.org/doi/abs/10.1161/CIRCOUTCOMES.122.009321

Integrating Community Health Workers into ... A CHW-led health coaching intervention was effective in achieving BP control among South Asian Americans in New York City primary care practices.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6469661/

Effect of Community Health Worker Support on Clinical ... We hypothesized that, compared with patients who did not receive CHW support, those enrolled in the IMPaCT program would have improved self-rated health, ...

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. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0293791

Preliminary efficacy of a community health worker homebased ... A home-based CHW intervention was significantly associated with reduction in BP among hypertensive patients compared to usual care.

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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06444308

Community Health Worker-led Hypertension Management This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician ...

8. ahrq.gov ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf

Outcomes of Community Health Worker Interventions To conduct a systematic review of the evidence on characteristics of community health workers (CHWs) and CHW interventions, outcomes of such interventions, ...