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

Hypertension Clinical Trial

— LINKED-BP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180045
• Other study ID #: IRB00307545
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: Yvonne Commodore-Mensah, PhD, MHS, RN
• Phone: 410-614-1519
• Email: ycommod1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• LINKED-BP Program
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.

Locations

Country	Name	City	State
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	Choptank Fassett Magee Medical and Cambridge Dental Center	Cambridge	Maryland
United States	Choptank Denton Health Center	Denton	Maryland
United States	Choptank Easton Health Center	Easton	Maryland
United States	Choptank Federalsburg Medical and Dental Center	Federalsburg	Maryland
United States	Johns Hopkins Community Physicians Fulton	Fulton	Maryland
United States	Choptank Goldsboro	Goldsboro	Maryland
United States	Choptank Bay Hundred	Saint Michaels	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in diastolic blood pressure	Change in diastolic blood pressure in millimeters of mercury (mmHg) over a 12 month period.	Baseline and 12 months