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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

Must not have

Patients with serious cognitive impairment or other conditions preventing their participation in the intervention

Diagnosis of end-stage renal disease (ESRD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood pressure is slightly high or I have stage 1 hypertension.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any mental conditions that prevent me from participating.

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My kidneys are in the final stage of chronic kidney disease.

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My upper arm circumference is more than 50 cm.

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I have a serious health condition that needs ongoing treatment.

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I do not have a condition like dialysis that affects test results.

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I am under 18 years old.

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I am taking medication for high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in systolic blood pressure

Secondary study objectives

Change in diastolic blood pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 9Eligibility criteria met