Clinical trial NCT05180045: Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure
Official title: Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
High Blood Pressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2022-01-06
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic blood pressure
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in diastolic blood pressure
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Johns Hopkins Community Physicians I Street
state: District of Columbia
city: Washington
country: United States
facility: Unity Upper Cardozo Health Center
state: District of Columbia
city: Washington
country: United States
facility: Unity Brentwood Health Center
state: District of Columbia
city: Washington
country: United States
facility: Unity East of the River
state: District of Columbia
city: Washington
country: United States
facility: Unity Minnesota Avenue Health Center
state: District of Columbia
city: Washington
country: United States
facility: Unity Parkside Health Center
state: District of Columbia
city: Washington
country: United States
facility: Unity Anacostia Health Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians Remington
state: Maryland
city: Bowie
country: United States
facility: Johns Hopkins Community Physicians Bowie
state: Maryland
city: Brandywine
country: United States
facility: Johns Hopkins Community Physicians Brandywine
state: Maryland
city: Cambridge
country: United States
facility: Choptank Fassett Magee Medical and Cambridge Dental Center
state: Maryland
city: Denton
country: United States
facility: Choptank Denton Health Center
state: Maryland
city: Dundalk
country: United States
facility: Johns Hopkins Community Physicians Greater Dundalk
state: Maryland
city: Easton
country: United States
facility: Choptank Easton Health Center
state: Maryland
city: Federalsburg
country: United States
facility: Choptank Federalsburg Medical and Dental Center
state: Maryland
city: Fulton
country: United States
facility: Johns Hopkins Community Physicians Fulton
state: Maryland
city: Goldsboro
country: United States
facility: Choptank Goldsboro
state: Maryland
city: Nottingham
country: United States
facility: Johns Hopkins Community Physicians White Marsh
state: Maryland
city: Saint Michaels
country: United States
facility: Choptank Bay Hundred
state: Maryland
city: White Plains
country: United States
facility: Johns Hopkins Community Physicans Charles County-White Plains
state: Maryland
Study officials:
affiliation: JHU School Of Nursing
name: Yvonne Commodore-Mensah, PhD, MHS, RN
role: PRINCIPAL_INVESTIGATOR
References: