Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure
Running, not enrolling · Not applicable
Conditions studied: Hypertension, High Blood Pressure
In brief
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.
Key facts
- Study ID
- NCT05180045
- Run by
- Johns Hopkins University
- People needed
- 472
- Starts
- 2023-07-17
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Community Physicians I Street — Washington D.C., District of Columbia, United States
- Unity Upper Cardozo Health Center — Washington D.C., District of Columbia, United States
- Unity Brentwood Health Center — Washington D.C., District of Columbia, United States
- Unity East of the River — Washington D.C., District of Columbia, United States
- Unity Minnesota Avenue Health Center — Washington D.C., District of Columbia, United States
- Unity Parkside Health Center — Washington D.C., District of Columbia, United States
- Unity Anacostia Health Center — Washington D.C., 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
- Johns Hopkins Community Physicians White Marsh — Nottingham, Maryland, United States
- Choptank Bay Hundred — Saint Michaels, Maryland, United States
- Johns Hopkins Community Physicans Charles County-White Plains — White Plains, Maryland, United States
Full record on ClinicalTrials.gov
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