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Home Blood Pressure Telemonitoring + Community Health Worker Support for High Blood Pressure (LINKED-BP Trial)

N/A
Recruiting
Led By Yvonne Commodore-Mensah, PhD, MHS, RN
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
18 years of age as of the date of data extraction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights

LINKED-BP Trial Summary

This trial will test if providing training, home BP monitors, telemonitoring, & counseling can help prevent high BP in high-risk adults.

Who is the study for?
Adults over 18 with elevated blood pressure or untreated stage 1 hypertension, who are non-Hispanic white, African-American, or Hispanic and receive care at participating centers. Excluded are those on blood pressure meds, with end-stage renal disease, serious conditions like cancer, cognitive impairments, or an upper arm circumference >50 cm.Check my eligibility
What is being tested?
The LINKED-BP Program tests a home blood pressure monitoring system linked to a telemonitoring app and community health worker support against usual care. The study involves training in BP measurement and lifestyle counseling for high-risk adults to manage their blood pressure.See study design
What are the potential side effects?
Since the intervention is non-pharmaceutical focusing on monitoring and education rather than medication, direct side effects aren't anticipated. However, there may be indirect effects from lifestyle changes advised by community health workers.

LINKED-BP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My blood pressure is slightly high or I have stage 1 hypertension.
Select...
I am 18 years old or older.

LINKED-BP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in systolic blood pressure
Secondary outcome measures
Change in diastolic blood pressure

LINKED-BP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LINKED-BP ProgramExperimental Treatment1 Intervention
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.
Group II: Enhanced Usual CareActive Control1 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.

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,836,897 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,026 Total Patients Enrolled
Yvonne Commodore-Mensah, PhD, MHS, RNPrincipal InvestigatorJHU School Of Nursing
1 Previous Clinical Trials
240 Total Patients Enrolled

Media Library

LINKED-BP Program Clinical Trial Eligibility Overview. Trial Name: NCT05180045 — N/A
High Blood Pressure Research Study Groups: LINKED-BP Program, Enhanced Usual Care
High Blood Pressure Clinical Trial 2023: LINKED-BP Program Highlights & Side Effects. Trial Name: NCT05180045 — N/A
LINKED-BP Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180045 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted for this trial at present?

"This medical experiment is currently recruiting patients, as indicated on clinicaltrials.gov. It was initially posted to the site on July 17th 2023 and its information has been recently updated for accuracy on July 21st 2023."

Answered by AI

What is the size of the cohort enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov has revealed that this clinical trial, which went public on July 17th 2023, is presently recruiting participants. 600 people must be enrolled at 2 separate medical venues before the study is complete."

Answered by AI

Who else is applying?

What site did they apply to?
Johns Hopkins Community Physicians Fulton
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have not used medication for high BO and would rather not. This trial, not using pharmaceuticals was of interest.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure
2023. "Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05180045.
All > Blood Pressure
~214 spots leftby Oct 2024
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