Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure

Not Applicable

Recruiting

• Conditions: Hypertension; High Blood Pressure
• Interventions: Behavioral: LINKED-BP Program

• Registration Number: NCT05180045
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-06
• Study Start: 2023-07-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• 18 years of age as of the date of data extraction
• Self-identify as non-Hispanic white, non-Hispanic African-American or Hispanic
• Have elevated BP (120-129/<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) (defined by AHA's 2017 hypertension clinical guidelines)
• Receives primary medical care at one of the participating community health centers and primary care practices

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Exclusion Criteria

• Age <18 years
• Prescribed antihypertensive medication
• Diagnosis of end-stage renal disease (ESRD)
• Condition which interferes with outcome measurement (e.g., dialysis)
• Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
• Patients with serious cognitive impairment or other conditions preventing their participation in the intervention
• Upper arm circumference >50 cm (maximum limit of the extra-large BP cuff)
• 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
• Unwillingness to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LINKED-BP Program	LINKED-BP Program	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.

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure	Baseline and 12 months	Change in systolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.

Secondary Outcome Measures

Name	Time	Method
Change in diastolic blood pressure	Baseline and 12 months	Change in diastolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.

Trial Locations

Locations (14)

Johns Hopkins Community Physicians White Marsh; 🇺🇸 Nottingham, Maryland, United States

Johns Hopkins Community Physicans Charles County-White Plains; 🇺🇸 White Plains, Maryland, United States

Johns Hopkins Community Physicians I Street; 🇺🇸 Washington, District of Columbia, United States

Johns Hopkins Community Physicians Remington; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Community Physicians Bowie; 🇺🇸 Bowie, Maryland, United States

Johns Hopkins Community Physicians Brandywine; 🇺🇸 Brandywine, Maryland, United States

Choptank Fassett Magee Medical and Cambridge Dental Center; 🇺🇸 Cambridge, Maryland, United States

Choptank Denton Health Center; 🇺🇸 Denton, Maryland, United States

Johns Hopkins Community Physicians Greater Dundalk; 🇺🇸 Dundalk, Maryland, United States

Choptank Easton Health Center; 🇺🇸 Easton, Maryland, United States

Choptank Federalsburg Medical and Dental Center; 🇺🇸 Federalsburg, Maryland, United States

Johns Hopkins Community Physicians Fulton; 🇺🇸 Fulton, Maryland, United States

Choptank Goldsboro; 🇺🇸 Goldsboro, Maryland, United States

Choptank Bay Hundred; 🇺🇸 Saint Michaels, Maryland, United States