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Home Blood Pressure Monitoring for High Blood Pressure (TB-HBPM Trial)

N/A
Recruiting
Led By Kevin Fiscella, MD, MPH
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current HFM patient 18-85 years of age with hypertension diagnosis
Be older than 18 years old
Must not have
Diagnosis of dementia, end-stage renal disease, and/or in hospice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months participation
Awards & highlights
No Placebo-Only Group

Summary

This trial will help identify strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) in primary care settings, in order to improve hypertension control rates.

Who is the study for?
This trial is for adults aged 18-85 with high blood pressure who are patients at participating practices. It includes practice employees involved in hypertensive patient care. People with dementia, end-stage renal disease, hospice care, or current pregnancy cannot join.
What is being tested?
The study tests a team-based home blood pressure monitoring program that lets patients send their readings to their health teams and receive coordinated hypertension care including education and monthly feedback.
What are the potential side effects?
Since this intervention involves monitoring and educational strategies rather than medication, it does not have the typical side effects associated with drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old with high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with dementia, end-stage renal disease, or am in hospice care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning with the 6-month intervention period and up to 48 months participation
This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning with the 6-month intervention period and up to 48 months participation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood pressure control
Secondary study objectives
Blood pressure control by insurance
Blood pressure control by race and ethnicity
Chronic disease self-management capacity (QICA)
+4 more
Other study objectives
Anti-hypertensive medication intensification
Bronchial Provocation Tests
Hypertensive disease
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Suite TB-HBPM throughout intervention implementationExperimental Treatment1 Intervention
Each suite will be randomized to implement the TB-HBPM program during one of three wedges separated by six months between each, 1.5 years later.
Group II: Suite TB-HBPM pre interventionExperimental Treatment1 Intervention
Each suite/cluster throughout the institution will begin in the baseline usual care phase in the first year.
Group III: Suite TB-HBPM post intervention implementationExperimental Treatment1 Intervention
Post implementation phase of the suites 2 years after introduction of intervention.

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
544,331 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,166,863 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,792,139 Total Patients Enrolled
Kevin Fiscella, MD, MPHPrincipal InvestigatorURMC
4 Previous Clinical Trials
6,146 Total Patients Enrolled

Media Library

Team-Based Home Blood Pressure Monitoring Clinical Trial Eligibility Overview. Trial Name: NCT05488795 — N/A
High Blood Pressure Research Study Groups: Suite TB-HBPM post intervention implementation, Suite TB-HBPM pre intervention, Suite TB-HBPM throughout intervention implementation
High Blood Pressure Clinical Trial 2023: Team-Based Home Blood Pressure Monitoring Highlights & Side Effects. Trial Name: NCT05488795 — N/A
Team-Based Home Blood Pressure Monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488795 — N/A
~1047 spots leftby Jul 2025
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