Clinical Trial

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

Study acronym: LINKED-BP
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-08-15
minor Completion moved earlier: 2026-09-30 -> 2026-07-25 2026-08-15
notable Primary completion pushed: 2026-06-28 -> 2026-08-01 2026-07-14
Trial Details
NCT Number NCT05180045
Lead Sponsor Johns Hopkins University
Collaborators: American Heart Association
Conditions Hypertension, High Blood Pressure
Enrollment 472 participants
Start Date 2023-07-17
Primary Completion 2026-07-25 (estimated)
Study Completion 2026-07-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-14