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

NCT05180045 | Active Not Recruiting

• 1 other identifier: IRB00307545
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 20

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.

Conditions

Hypertension; High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure

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

  Baseline and 12 months

Secondary Outcomes (1)

• Change in diastolic blood pressure

  Baseline and 12 months

Study Arms (2)

LINKED-BP Program

EXPERIMENTAL

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.

Behavioral: LINKED-BP Program

Enhanced Usual Care

NO INTERVENTION

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.

Interventions

LINKED-BP Program BEHAVIORAL

The intervention arm will include training on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. Patients will be trained to measure their BP in the morning and evening for 7 days. Patients enter data using Bluetooth device transmission or manual entry. Guidance is provided on accurate BP measurement. The app stores and securely relays data to the cloud. The primary care provider and CHW will be able to visualize the remotely transmitted data via the clinician portal. Other components of usual care at the practices may include dietary counseling, on-site clinical pharmacists, social workers, case managers as needed for BP follow up, and assistance with medications and appointments as needed. The intervention period for each study participant is 12 months.

LINKED-BP Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Heart Association: collaborator

Study Sites (20)

Johns Hopkins Community Physicians I Street

Washington D.C., District of Columbia, 20005, United States

Location

Unity Upper Cardozo Health Center

Washington D.C., District of Columbia, 20009, United States

Location

Unity Brentwood Health Center

Washington D.C., District of Columbia, 20018, United States

Location

Unity East of the River

Washington D.C., District of Columbia, 20019, United States

Location

Unity Minnesota Avenue Health Center

Washington D.C., District of Columbia, 20019, United States

Location

Unity Parkside Health Center

Washington D.C., District of Columbia, 20019, United States

Location

Unity Anacostia Health Center

Washington D.C., District of Columbia, 20020, United States

Location

Johns Hopkins Community Physicians Remington

Baltimore, Maryland, 21211, United States

Location

Johns Hopkins Community Physicians Bowie

Bowie, Maryland, 20715, United States

Location

Johns Hopkins Community Physicians Brandywine

Brandywine, Maryland, 20613, United States

Location

Choptank Fassett Magee Medical and Cambridge Dental Center

Cambridge, Maryland, 21613, United States

Location

Choptank Denton Health Center

Denton, Maryland, 21629, United States

Location

Johns Hopkins Community Physicians Greater Dundalk

Dundalk, Maryland, 21222, United States

Location

Choptank Easton Health Center

Easton, Maryland, 21601, United States

Location

Choptank Federalsburg Medical and Dental Center

Federalsburg, Maryland, 21632, United States

Location

Johns Hopkins Community Physicians Fulton

Fulton, Maryland, 20759, United States

Location

Choptank Goldsboro

Goldsboro, Maryland, 21636, United States

Location

Johns Hopkins Community Physicians White Marsh

Nottingham, Maryland, 21236, United States

Location

Choptank Bay Hundred

Saint Michaels, Maryland, 21663, United States

Location

Johns Hopkins Community Physicans Charles County-White Plains

White Plains, Maryland, 20695, United States

Location

Related Publications (1)

• Commodore-Mensah Y, Liu X, Ogungbe O, Ibe C, Amihere J, Mensa M, Martin SS, Crews D, Carson KA, Cooper LA, Himmelfarb CR. Design and Rationale of the Home Blood Pressure Telemonitoring Linked with Community Health Workers to Improve Blood Pressure (LINKED-BP) Program. Am J Hypertens. 2023 Apr 15;36(5):273-282. doi: 10.1093/ajh/hpad001.

  PMID: 37061796 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yvonne Commodore-Mensah, PhD, MHS, RN

  JHU School Of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 6, 2022
• Study Start: July 17, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (20)