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

NCT05180045 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2025-10-09

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

LINKED-BP Program

The intervention arm will include training on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. Patients will be trained to measure their BP in the morning and evening for 7 days. Patients enter data using Bluetooth device transmission or manual entry. Guidance is provided on accurate BP measurement. The app stores and securely relays data to the cloud. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. Other components of usual care at the practices may include dietary counseling, on-site clinical pharmacists, social workers, case managers as needed for BP follow up, and assistance with medications and appointments as needed. The intervention period for each study participant is 12 months.

Sponsors & Collaborators

Principal Investigators

  • Yvonne Commodore-Mensah, PhD, MHS, RN · JHU School Of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2026-06-01
Completion
2026-06-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05180045 on ClinicalTrials.gov