472 Participants Needed

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

(LINKED-BP Trial)

Recruiting at 19 trial locations
YC
Overseen ByYvonne Commodore-Mensah, PhD, MHS, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the LINKED-BP Program treatment for high blood pressure?

Research shows that home blood pressure monitoring, especially when combined with support from community health workers, can significantly reduce blood pressure. Studies have found that people who monitor their blood pressure at home and receive guidance from community workers or pharmacists have better blood pressure control compared to those who receive usual care.12345

Is the Home Blood Pressure Telemonitoring + Community Health Worker Support program safe for humans?

Research indicates that home blood pressure telemonitoring combined with community health worker support is generally safe for humans. Studies have not reported significant adverse events, suggesting it is a safe approach for managing high blood pressure.12367

What makes the LINKED-BP Program treatment unique for high blood pressure?

The LINKED-BP Program is unique because it combines home blood pressure monitoring with a mobile health app and support from community health workers, who provide personalized guidance and education. This approach not only focuses on medical management but also addresses social factors that affect health, making it particularly effective for underserved communities.23578

What is the purpose of this trial?

The LINKED-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo) that links with all Bluetooth-enabled validated blood pressure (BP) devices, support from community health workers (CHWs), and BP measurement training at community health centers serving high-risk adults to prevent stage 2 hypertension (BP ≥ 140/90 mm Hg). The LINKED-BP Program study will recruit a total of 600 adults (30 from each practice) with elevated BP (120-129/\<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) across 20 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors (HBPM) and will be managed by the patients' primary care clinicians as usual; and (2) the LINKED-BP Program or "intervention arm," which will include training of patients on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. The intervention period for each study participant is 12 months.

Research Team

YC

Yvonne Commodore-Mensah, PhD, MHS, RN

Principal Investigator

JHU School Of Nursing

Eligibility Criteria

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
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: LINKED-BP ProgramExperimental Treatment1 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 CareActive Control1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]
Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. [2023]
Community Lay Worker Guided Home-Based Monitoring Program for Hypertension Control. [2020]
Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists. [2020]
5.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
An Integrated Community-Based Blood Pressure Telemonitoring Program - A Population-Based Observational Study. [2022]
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]
Role of community programs in controlling blood pressure. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security