AzTrials
AzTrials

High Blood PressureTB-HBPMNCT05488795

Team-Based Home Blood Pressure Monitoring

A study testing Team-Based Home Blood Pressure Monitoring in people with High Blood Pressure and Hypertension, run by University of Rochester at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The overall goal of this study is to identify and rigorously evaluate strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) within primary care. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
High Blood Pressure, Hypertension
What is being tested?
Team-Based Home Blood Pressure Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,760 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

ELIGIBILITY CRITERIA

Clinicians and Staff Eligibility Criteria Practice employees (practice leaders, administrators, clinicians, or staff) that work with hypertensive patients during the study period (scheduling appointments, coordinating care, measuring blood pressure, responding to questions, and/or treating their blood pressure)

Patient Inclusion Criteria

  • Current HFM patient 18-85 years of age with hypertension diagnosis
  • Diagnosis of hypertension based on ICD-10 codes of I10-I14
  • at least one HFM health visit and hypertension diagnosis beginning no later than 7/1/2021.

Patient Exclusion Criteria

  • Not current patient in the participating practices
  • Diagnosis of dementia, end-stage renal disease, and/or in hospice
  • Currently pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Highland Family Medicine

    Rochester, New York, 14620

Other trials in United States

About this study

Official title: Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care

The overall goal of this study is to identify and rigorously evaluate strategies for implementing and sustaining team-based home blood pressure monitoring (TB-HBPM) within primary care.

The TB-HBPM intervention is a multifaceted program involving patient transmission of blood readings to EHR and clinical decision support. Implementation strategies include group-based education on hypertension measurement, target blood pressure goals, drug and lifestyle management, referral to community resources, and team training designed to optimize the coordination of hypertension care, and monthly audit and feedback reports to teams and clinicians.

Hypertension control rates are suboptimal in many primary care practices with persistent racial disparities in control. Team-based home blood pressure monitoring (TB-HPBM) involving patient transmission of their home blood pressure readings in real-time to their clinical team has been shown to improve blood pressure control. There is an urgent need to implement TB-HBPM into practice. The overall objective of this research is to assess implementation strategies that mitigate barriers and leverage facilitators to TB-HBHM on hypertension control and disparities between Black and White patients. The study team and investigators will use mixed methods to assess the process and generate knowledge to facilitate broader uptake of TB-HBPM.

Read the detailed description

Aim 2: Deploy theorized implementation strategies using a type-2 hybrid stepped-wedge randomized cluster trial The department of family medicine will roll out the clinical intervention (TBHBPM).

To improve rigor in evaluation, the study biostatistician will use computer-generated numbers to randomly assign each of the eight suites to when they will begin the intervention during one of three wedges (Figure 1). The study team and investigators will randomize two suites in the first wedge and three each to the second and third wedge.

Aim 3: Assess the impact of implementation strategies using specific metrics based on RE-AIM

Aim 4: Test theoretical assumptions underlying the implementation strategies

Being tested
Team-Based Home Blood Pressure Monitoring
Keywords
Home blood pressure monitoring, Hypertension control, Primary Care Teams, Implementation Research, Health Equity, Clinical Trial
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Team-Based Home Blood Pressure MonitoringBehavioural

    Implementation of best practices for hypertension control using a practice wide team-based home blood pressure monitoring intervention

Study groups in NCT05488795
Study groupRoleWhat they receive
Suite TB-HBPM pre interventionOtherEach suite/cluster throughout the institution will begin in the baseline usual care phase in the first year.
Receives: Behavioral: Team-Based Home Blood Pressure Monitoring
Suite TB-HBPM throughout intervention implementationOtherEach 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.
Receives: Behavioral: Team-Based Home Blood Pressure Monitoring
Suite TB-HBPM post intervention implementationOtherPost implementation phase of the suites 2 years after introduction of intervention.
Receives: Behavioral: Team-Based Home Blood Pressure Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure control

    Change in percent of participants whose BP is controlled (defined as <140/90 mm Hg) among all eligible patients diagnosed with hypertension based on the last BP reading during the control period and the last BP reading during the follow-up period.

    Measured: Up to 48 months participation

Secondary outcomes (7)

  1. Blood pressure control by race and ethnicity

    Change in percent of participants with blood pressure controlled defined as <140/90 mm Hg by race/ethnicity: among eligible Non-Hispanic White patients, non-Hispanic Black patients, and Hispanic patients.

    Measured: Up to 48 months participation

  2. Blood pressure control by insurance

    Change in percent of participants with blood pressure controlled defined as <140/90 mm Hg by insurance (Commercial, Medicaid, Medicare, Other and None)

    Measured: Up to 48 months participation

  3. Participation in Home Blood Pressure Monitoring (HBPM)

    Percentage of participants eligible for home blood pressure monitoring (HBPM) who agree to participate in HBPM based on EHR documentation

    Measured: Beginning of the intervention for the relevant wedge up to 48 months participation

  4. Transmission of home blood pressure readings

    Percentage of participants who participate in HPBM who transmit a least 10 BP readings per month

    Measured: First three months following each participant's enrollment in HBPM

  5. Chronic disease self-management capacity (QICA)

    Change in Quality Improvement Capacity Assessment QICA scores, scale range 20-200 with higher indicating better outcomes.

    Measured: Pre-intervention and six months post-intervention

  6. Sustained blood pressure control

    Change in percent of participants with blood pressure in control (<140/90 mm Hg) post-intervention

    Measured: Beginning with the 6-month intervention period and up to 48 months participation

  7. Cost Analysis

    Marginal changes in net revenue (marginal billing and bonus revenue) and marginal changes in costs related to time for training, staffing costs, and BP monitor

    Measured: Up to 48 months participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start1 Oct 2022
  3. Primary completion31 Dec 2025
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped Wedge Cluster Randomized Design. Each practice suite represents a cluster. All eight suites begin in the control group and then cross over (one-way) to the intervention group at one of three randomly assigned time periods, ensuring that all suites eventually receive implementation of TB-HBPM.
Masking
None (open label)
Enrolment
5,760 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05488795
Sponsor's protocol ID
RSRB 6036
Other IDs
R33HL157643
Acronym
TB-HBPM
Status last verified
Jan 2026
First submitted
6 Jul 2022
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data Quality and Management a. Description of Plan for Data Quality and Management - The PI will review all data collection forms on an ongoing basis for data completeness and accuracy as well as protocol compliance. A statement reflecting the results of the review will be sent to the NIH in the annual report. The EHR is the primary data source. EHR data quality will be assessed using extreme outlier data, missing data for outcome variables (i.e. office or transmitted blood pressure readings, dates of visits, participant ID), and loss to follow-up (no data for the participant appears in EHR, e.g. due to relocation, left practice etc). Note: clinical staff will conduct outreach to all participants as part of sound clinical practice. Regular data checks and data cleaning will be deployed to optimize data quality. Multiple imputation methods will be used as necessary to address missing data as described in the statistical analysis.

Publications

  • Fiscella K, Luque A, Johnson BA, Sanders M, Sass E, Cassells A, Holder T, Thomas M, Harrington D, Tian Y, Carroll J, Venci J, Williams SK, Tobin JN. Translating the ABCSs into HIV Care: A Stepped Wedge Cluster Randomized Clinical Trial. J Gen Intern Med. 2026 May 4. doi: 10.1007/s11606-026-10482-8. Online ahead of print.

    PubMed 42082850

  • Fiscella KA, Sass E, Sridhar SB, Maguire JA, Lashway K, Wong G, Thien A, Thomas M, Bisognano JD, Rosenberg T, Sanders MR, Johnson BA, Polgreen LA. Team-based home blood pressure monitoring for blood pressure equity a protocol for a stepped wedge cluster randomized trial. Contemp Clin Trials. 2023 Nov;134:107332. doi: 10.1016/j.cct.2023.107332. Epub 2023 Sep 16.

    PubMed 37722482

Questions about this trial

What is this clinical trial studying?

A study testing Team-Based Home Blood Pressure Monitoring in people with High Blood Pressure and Hypertension, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure control (time frame: Up to 48 months participation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488795, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in