- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556783
Increasing the Use of Self Measured Home Blood Pressure Logs in the Management of Hypertension
April 23, 2026 updated by: AdventHealth
Telephone-Based Patient Outreach to Improve Self-Measured Blood Pressure Log Utilization in Chronic Hypertension: A Pragmatic Quality Improvement Randomized Implementation Trial
The Telephone-Based Patient Outreach to Improve Home Blood Pressure Monitoring (HBPM) in Chronic Hypertension study is a pragmatic, randomized, open-label quality improvement implementation trial designed to evaluate the effectiveness of a structured telephone outreach intervention in increasing the proportion of patients with chronic hypertension who present to clinic visits with a completed home blood pressure log compared to the receipt of usual primary care services over a 90-day period.
The study aims to address the inconsistent integration of HBPM-an evidence-based strategy endorsed by major guidelines to improve diagnostic accuracy and longitudinal management-into routine primary care workflows where no standardized educational or documentation process currently exists.
Patients with documented chronic uncontrolled hypertension, defined as three documented readings exceeding 130/80 mmHg, are eligible for participation.
Typically, patients at this academic primary care practice lack a standardized process for receiving education on home monitoring or a dedicated mechanism for documenting logs, which can lead to therapeutic inertia and missed opportunities to optimize treatment.
The intervention is designed around a structured telephone outreach program led by medical students using a standardized script to provide direct patient education on the clinical value of HBPM and to encourage the completion and presentation of BP logs during subsequent primary care visits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Orlando, Florida, United States, 32792
- AdventHealth Winter Park
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must have a documented diagnosis of chronic uncontrolled hypertension
- "Uncontrolled" was defined as having three documented blood pressure readings exceeding 130/80 mmHg within the electronic health record.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
The control arm represents usual care, wherein patients receive standard medical management for chronic hypertension without any additional telephone outreach or targeted education regarding blood pressure logging workflows.
|
|
|
Experimental: A structured, telephone-based educational outreach to encourage HBPM
The intervention arm consists of a structured, telephone-based educational outreach led by medical students using a standardized script to provide brief education on the clinical value of HBPM and to encourage patients to maintain and present a monitoring log at their subsequent clinic visit.
This arm utilizes a maximum of two call attempts per patient with no voicemail messages left to determine if a simple, low-resource reminder can influence patient behavior.
|
Telephone-based educational outreach to encourage HBPM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HBPM Log Adherence
Time Frame: Adherence was measured at follow-up within a 90-day window of the intervention.
|
The primary outcome was the proportion of patients with a documented home blood pressure log in the electronic health record (EHR).
A "documented log" was operationally defined as any notation in the medical record indicating that a patient presented with, reported, or submitted home blood pressure readings, whether through a scanned paper log, free-text documentation in a clinical note, or an entry in a structured data field
|
Adherence was measured at follow-up within a 90-day window of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Blood Pressure
Time Frame: The most recent follow-up measurement recorded within a 90-day window of the intervention.
|
The secondary outcomes consisted of the mean change in both systolic and diastolic blood pressure.
These clinical metrics were selected to evaluate the impact of the HBPM intervention on objective blood pressure control
|
The most recent follow-up measurement recorded within a 90-day window of the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2025
Primary Completion (Actual)
April 8, 2026
Study Completion (Actual)
April 8, 2026
Study Registration Dates
First Submitted
April 23, 2026
First Submitted That Met QC Criteria
April 23, 2026
First Posted (Actual)
April 29, 2026
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 23, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2370579-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
email primary investigator
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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