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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension Cardiovascular Diseases High Blood Pressure Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Community Physicians I Street, Washington D.C., District of Columbia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

LINKED-BP Program

Behavioral

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.

Primary outcomes

Change in systolic blood pressure

Time frame: Baseline and 12 months

Change in systolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.

Secondary outcomes

Change in diastolic blood pressure

Time frame: Baseline and 12 months

Change in diastolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

American Heart Association

Registry information

Acronym: LINKED-BP

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jan 6, 2022
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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