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

Not Applicable
Active, not recruiting
Conditions
Hypertension
High Blood Pressure
Registration Number
NCT05180045
Lead Sponsor
Johns Hopkins University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
472
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in systolic blood pressureBaseline and 12 months

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

Secondary Outcome Measures
NameTimeMethod
Change in diastolic blood pressureBaseline and 12 months

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

Trial Locations

Locations (20)

Johns Hopkins Community Physicians I Street

🇺🇸

Washington, District of Columbia, United States

Unity Upper Cardozo Health Center

🇺🇸

Washington, District of Columbia, United States

Unity Brentwood Health Center

🇺🇸

Washington, District of Columbia, United States

Unity East of the River

🇺🇸

Washington, District of Columbia, United States

Unity Minnesota Avenue Health Center

🇺🇸

Washington, District of Columbia, United States

Unity Parkside Health Center

🇺🇸

Washington, District of Columbia, United States

Unity Anacostia Health Center

🇺🇸

Washington, 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

Scroll for more (10 remaining)
Johns Hopkins Community Physicians I Street
🇺🇸Washington, District of Columbia, United States

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