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

Last updated: October 3, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Diabetes And Hypertension

Williams Syndrome

Treatment

LINKED-BP Program

Clinical Study ID

NCT05180045
IRB00307545
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 centersand primary care practices

Exclusion

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 activemanagement (e.g., cancer)

  • Patients with serious cognitive impairment or other conditions preventing theirparticipation 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 receiveprimary care

  • Unwillingness to provide informed consent

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: LINKED-BP Program
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
October 01, 2026

Connect with a study center

  • Johns Hopkins Community Physicians I Street

    Washington, District of Columbia 20005
    United States

    Active - Recruiting

  • Johns Hopkins Community Physicians Remington

    Baltimore, Maryland 21211
    United States

    Completed

  • Johns Hopkins Community Physicians Bowie

    Bowie, Maryland 20715
    United States

    Completed

  • Johns Hopkins Community Physicians Brandywine

    Brandywine, Maryland 20613
    United States

    Active - Recruiting

  • Choptank Fassett Magee Medical and Cambridge Dental Center

    Cambridge, Maryland 21613
    United States

    Completed

  • Choptank Denton Health Center

    Denton, Maryland 21629
    United States

    Completed

  • Johns Hopkins Community Physicians Greater Dundalk

    Dundalk, Maryland 21222
    United States

    Completed

  • Choptank Easton Health Center

    Easton, Maryland 21601
    United States

    Active - Recruiting

  • Choptank Federalsburg Medical and Dental Center

    Federalsburg, Maryland 21632
    United States

    Completed

  • Johns Hopkins Community Physicians Fulton

    Fulton, Maryland 20759
    United States

    Completed

  • Choptank Goldsboro

    Goldsboro, Maryland 21636
    United States

    Completed

  • Johns Hopkins Community Physicians White Marsh

    Nottingham, Maryland 21236
    United States

    Active - Recruiting

  • Choptank Bay Hundred

    Saint Michaels, Maryland 21663
    United States

    Completed

  • Johns Hopkins Community Physicans Charles County-White Plains

    White Plains, Maryland 20695
    United States

    Active - Recruiting

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