Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure (LINKED-BP)

Johns Hopkins University

Status: Active, not recruiting

Conditions: Hypertension; High Blood Pressure

Treatments: Behavioral: LINKED-BP Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05180045

IRB00307545

Details and patient eligibility

About

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.

Enrollment: 472 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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472 participants in 2 patient groups

LINKED-BP Program

Experimental group

Description:

Patients in the LINKED-BP Program will be trained to measure their BP with an Omron 10 series device. Patients who have smartphones will download the patient facing app and receive a unique link from the study team. Patients who do not own a smartphone will be provided one with a data plan for the duration of the study. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. CHWs will support patients by: (1) providing education on how to manage BP through self-monitoring and practicing dietary modification and exercise; (2) reinforcing positive BP self-management through follow-up encounters; (3) assisting with linkages to existing clinical and administrative services; and (4) link participants with community resources to address health-related social needs. The staff in each participating community health center practice will be trained in blood pressure measurement best practices.

Treatment:

Behavioral: LINKED-BP Program

Enhanced Usual Care

No Intervention group

Description:

Patients in the Enhanced Usual Care Arm, will receive care as usual from thier primary care provider and will be trained to measure their BP with an Omron 10 series device. The staff in each participating community health center practice will be trained in blood pressure measurement best practices.