Home Blood Pressure Telemonitoring + Community Health Worker Support for High Blood Pressure

(LINKED-BP Trial)

Not currently recruiting at 26 trial locations

Overseen By Yvonne Commodore-Mensah, PhD, MHS, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Antihypertensives

Disqualifiers: ESRD, Cancer, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program to manage high blood pressure (BP) through home monitoring and support from community health workers. One group will receive usual care with a home BP monitor, while the other will receive additional support, including training on BP measurement, use of a telemonitoring app, and lifestyle advice. The LINKED-BP Program targets adults with high BP who are not yet on medication and receive care at specific health centers. Individuals informed of higher-than-normal BP but not on treatment may find this trial suitable. As an unphased trial, this study provides a unique opportunity to explore innovative methods for managing high BP with personalized support.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those already on antihypertensive medication. If you are on such medication, you would not be eligible to participate.

What prior data suggests that this program is safe for managing high blood pressure?

Research has shown that the LINKED-BP Program helps individuals monitor their blood pressure at home using a telemonitoring app called Sphygmo. The program includes support from community health workers who provide education and lifestyle advice. These methods are well-known for managing high blood pressure.

Home blood pressure monitors and telemonitoring apps are generally safe. These tools are designed to be user-friendly and non-invasive. No reports of serious side effects or problems have emerged with this approach. Support from community health workers adds extra safety by offering guidance and helping participants understand how to manage their condition effectively.

As this is a "Not Applicable" phase trial, the study observes existing methods rather than testing a new drug. This indicates that the safety of these methods is already well understood, with no new treatment introduced that might have unknown risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LINKED-BP Program because it combines home blood pressure telemonitoring with personalized support from community health workers (CHWs), offering a fresh approach to managing high blood pressure. Unlike the standard care, which typically involves routine checkups and medication, this program empowers patients to actively monitor their blood pressure using a digital device and app, even providing smartphones to those who need them. The involvement of CHWs is particularly unique, as they offer ongoing education, support, and link patients to necessary resources, potentially addressing not just medical needs but social factors affecting health as well. This comprehensive, tech-enabled approach could lead to more effective blood pressure management and improved overall health outcomes.

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

Research has shown that the LINKED-BP Program, which participants in this trial may receive, can effectively manage high blood pressure. This program combines home blood pressure monitoring, a telemonitoring app called Sphygmo, and support from community health workers. This approach enables patients to regularly check their blood pressure and receive advice on lifestyle changes. Early results indicate that patients in this program achieve better blood pressure control than those in the Enhanced Usual Care arm, who only monitor their blood pressure at home. Thus, the LINKED-BP Program could be a promising method to prevent more serious high blood pressure. ^{1 2 4 5 6}

Who Is on the Research Team?

Yvonne Commodore-Mensah, PhD, MHS, RN

Principal Investigator

JHU School Of Nursing

Are You a Good Fit for This Trial?

Adults over 18 with elevated blood pressure or untreated stage 1 hypertension, who are non-Hispanic white, African-American, or Hispanic and receive care at participating centers. Excluded are those on blood pressure meds, with end-stage renal disease, serious conditions like cancer, cognitive impairments, or an upper arm circumference >50 cm.

Inclusion Criteria

Receives primary medical care at one of the participating community health centers and primary care practices

My blood pressure is slightly high or I have stage 1 hypertension.

Self-identify as non-Hispanic white, non-Hispanic African-American or Hispanic

Exclusion Criteria

I do not have any mental conditions that prevent me from participating.

Those planning to leave the practice or move out of the geographic area in 18 months

Those who no longer consider the practice site the location where they receive primary care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive training on home blood pressure monitoring, use of the Sphygmo telemonitoring app, and support from community health workers for lifestyle modification

12 months

Regular CHW visits for education and counseling

Follow-up

Participants are monitored for changes in blood pressure and overall health outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LINKED-BP Program

Trial Overview The LINKED-BP Program tests a home blood pressure monitoring system linked to a telemonitoring app and community health worker support against usual care. The study involves training in BP measurement and lifestyle counseling for high-risk adults to manage their blood pressure.

How Is the Trial Designed?

Group I: LINKED-BP Program Experimental Treatment 1 Intervention

Patients in the LINKED-BP Program will be trained to measure their BP with an Omron 10 series device. Patients who have smartphones will download the patient facing app and receive a unique link from the study team. Patients who do not own a smartphone will be provided one with a data plan for the duration of the study. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. CHWs will support patients by: (1) providing education on how to manage BP through self-monitoring and practicing dietary modification and exercise; (2) reinforcing positive BP self-management through follow-up encounters; (3) assisting with linkages to existing clinical and administrative services; and (4) link participants with community resources to address health-related social needs. The staff in each participating community health center practice will be trained in blood pressure measurement best practices.

Group II: Enhanced Usual Care Active Control 1 Intervention

Patients in the Enhanced Usual Care Arm, will receive care as usual from thier primary care provider and will be trained to measure their BP with an Omron 10 series device. The staff in each participating community health center practice will be trained in blood pressure measurement best practices.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Home blood pressure telemonitoring (HBPT) significantly improved blood pressure control, reducing systolic blood pressure by 4.71 mmHg and diastolic blood pressure by 2.45 mmHg compared to usual care, with a higher proportion of patients achieving normalized blood pressure levels.

While HBPT led to increased healthcare costs per patient, it also improved the physical quality of life and did not increase the risk of adverse events, suggesting it is a beneficial but more expensive option for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. Omboni, S., Gazzola, T., Carabelli, G., et al.[2023]

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]

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]

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 Hyperlink trial demonstrated that a 12-month intervention combining home blood pressure telemonitoring with pharmacist case management significantly improved blood pressure control in adults with uncontrolled hypertension, achieving 71% control at 12 months compared to 53% in usual care.

Key factors contributing to the success of the intervention included strong patient-pharmacist relationships, individualized treatment plans, and frequent communication, which facilitated timely adjustments to antihypertensive medications and led to rapid blood pressure reductions within just 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists. Beran, M., Asche, SE., Bergdall, AR., et al.[2020]

The LINKED-BP Program, which combines home blood pressure monitoring with a mobile health app and support from community health workers, aims to reduce blood pressure in underserved populations, specifically targeting Black and Hispanic adults and those living in poverty.

This study will involve 600 adults with elevated blood pressure over 12 months, assessing the program's effectiveness in lowering systolic blood pressure and its potential to improve health equity in hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. Commodore-Mensah, Y., Liu, X., Ogungbe, O., et al.[2023]

A study focused on vulnerable adults showed that educating them on home blood pressure monitoring led to a significant reduction in systolic blood pressure, indicating improved hypertension control.

The use of community lay workers to guide individuals in this home monitoring program was validated by participants, suggesting it effectively met their needs for managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Lay Worker Guided Home-Based Monitoring Program for Hypertension Control. Woods, SS., Costanzo, CL.[2020]

The Health+ community-based blood pressure telemonitoring program significantly reduced emergency department visits and hospitalization rates among 9,546 high-risk adults, indicating improved health outcomes.

Participants in the Health+ program experienced lower healthcare costs and shorter hospital stays, particularly benefiting younger individuals and those with fewer comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Community-Based Blood Pressure Telemonitoring Program - A Population-Based Observational Study. Yang, JY., Wu, YW., Chuang, W., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10105861/

Design and Rationale of the Home Blood Pressure ... The “LINKED-BP Program” is a multi-level intervention linking home blood pressure (BP) monitoring with a mobile health application, support from community ...

2. ahajournals.org ahajournals.org/doi/10.1161/circ.147.suppl_1.P376

Abstract P376: Home Blood Pressure Telemonitoring ... Patients in the LINKED-BP Program receive training on HBPM with a validated home BP monitor, BP telemonitoring through the Sphygmo app, and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37061796/

Design and Rationale of the Home Blood Pressure ... - PubMed The LINKED-BP Program is a multi-level intervention linking home blood pressure (BP) monitoring with a mobile health application, support from community health ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05180045/home-blood-pressure-telemonitoring-linked-with-community-health-workers-to-improve-blood-pressure

Home Blood Pressure Telemonitoring LINKED With ... The LINKED-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo)

5. chwcentral.org chwcentral.org/resources/design-and-rationale-of-the-home-blood-pressure-telemonitoring-linked-with-community-health-workers-to-improve-blood-pressure-linked-bp-program/

Design and Rationale of the Home Blood Pressure ... This paper outlines the design and rationale for a planned study which seeks to examine the effect of the LINKED-BP Program on blood pressure ( ...

6. ahajournals.org ahajournals.org/doi/10.1161/cir.151.suppl_1.P3169?doi=10.1161/cir.151.suppl_1.P3169

Abstract P3169: Significant Social Determinants of Health ... Methods: This cross-sectional study analyzed baseline data from the LINKED-BP (Home Blood Pressure Telemonitoring Linked with Community Health ...