Home Blood Pressure Telemonitoring + Community Health Worker Support for High Blood Pressure
(LINKED-BP Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Must not be taking: Antihypertensives
Disqualifiers: ESRD, Cancer, Cognitive impairment, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12367What 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.
23578Eligibility 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
+1 more
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
+7 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Johns Hopkins Community Physicians I StreetWashington, United States
Johns Hopkins Community Physicians BrandywineBrandywine, MD
Choptank Easton Health CenterEaston, MD
Johns Hopkins Community Physicans Charles County-White PlainsWhite Plains, MD
More Trial Locations
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
American Heart AssociationCollaborator
References
Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. [2023]To systematically review data from randomized controlled studies on the effectiveness of home blood pressure telemonitoring (HBPT) versus usual care with respect to improvement of BP control, healthcare resources utilization and costs, patient's quality of life and adverse events.
Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. [2023]Disparities in hypertension outcomes persist among Black and Hispanic adults and persons living in poverty in the United States. The "LINKED-BP Program" is a multi-level intervention linking home blood pressure (BP) monitoring with a mobile health application, support from community health workers (CHWs), and BP measurement training at primary care practices to improve BP. This study is part of the American Heart Association RESTORE (AddREssing Social Determinants TO pRevent hypErtension) Network. This study aims to examine the effect of the LINKED-BP Program on BP reduction and to evaluate the reach, adoption, sustainability, and cost-effectiveness of the intervention.
Community Lay Worker Guided Home-Based Monitoring Program for Hypertension Control. [2020]Purpose: The purpose of this study was to determine the incidence of hypertension (HTN), compare clinic versus home visit blood pressure (BP) control, and examine the feasibility of home BP monitoring in a vulnerable adult population. Significance: HTN control continues to be an unmet health maintenance challenge across America. This project used a community lay worker (CLW) to guide individuals in a home BP monitoring program for HTN control. Results: Individuals who were educated in monitoring BP at home significantly reduced their systolic BP. Participants validated that this method was effective in meeting their needs for BP control.
Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists. [2020]The Hyperlink trial tested a 12-month intervention of home blood pressure (BP) telemonitoring with pharmacist case management in adults with uncontrolled hypertension. The intervention resulted in improved BP control compared with usual care at both 6 (72% vs. 45%; P
An Integrated Community-Based Blood Pressure Telemonitoring Program - A Population-Based Observational Study. [2022]Label="Background" NlmCategory="UNASSIGNED">Home blood pressure telemonitoring (BPT) has been shown to improve blood pressure control. A community-based BPT program (the Health+ program) was launched in 2015 in an urban area around a medical center.
Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]A considerable body of research indicates that community health workers (CHWs) are effective in improving chronic disease care and health outcomes. Much of the focus of cardiovascular research involving CHWs has been on hypertension because of its high prevalence and because it is a major risk factor for cardiovascular, cerebrovascular, and renal diseases. Adding CHWs to the patient-provider team has a beneficial effect on the quality of care for populations most in need. CHWs have contributed to significant improvements in community members' access to and continuity of care and adherence to treatment for the control of hypertension. CHWs assume multiple roles, including patient and community education, patient counseling, monitoring patient health status, linking people with health and human services, and enhancing provider patient communication and adherence to care. Current recommendations for CHWs to be interventionists on healthcare teams and in community-based research increase opportunities for CHWs to play an important role in eliminating disparities in heart disease and stroke. Adequate translation of research into clinical practice remains a major challenge, however. Addressing this issue, which has national implications, will require sustainable funding; appropriate reimbursement; enhanced efforts to incorporate CHWs into healthcare teams; better utilization of their skills; improved CHW supervision, training, and career development; policy changes; and ongoing evaluation, including a reporting of costs.
Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. [2019]This study assessed the effectiveness of enhanced tracking and follow-up services provided by community health workers in promoting medical follow-up of persons whose elevated blood pressures were detected during blood pressure measurement at urban community sites.
Role of community programs in controlling blood pressure. [2019]Despite more than 30 years of intense activity to improve control--and more recently prevention--high blood pressure continues to be a major public health problem. Evidence-based reviews have identified best practices and quality improvement strategies to address prevention and control. Since the 1970s, community-based programs have been instrumental in raising awareness, increasing knowledge, and promoting changes in health behavior to improve blood pressure control. Most of these programs have emphasized the use of partnerships and involvement of community residents in conducting screening and referral activities, implementing clinical practice guidelines, and increasing healthy eating and physical activity. Many also have used health care team approaches, including the use of trained community health workers to deliver targeted, culturally sensitive heart health education, particularly related to the prevention of cardiovascular disease risk factors in general and high blood pressure in particular. Increased focus on implementation of evidence-based lifestyle and clinical management strategies coupled with community-based approaches may help increase blood pressure control rates within communities.