NCT07556783

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • HBPM Log Adherence

    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 Outcomes (1)

  • Change in Blood Pressure

    The most recent follow-up measurement recorded within a 90-day window of the intervention.

Study Arms (2)

Usual Care

NO INTERVENTION

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.

A structured, telephone-based educational outreach to encourage HBPM

EXPERIMENTAL

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.

Other: A structured, telephone-based educational outreach to encourage HBPM

Interventions

Telephone-based educational outreach to encourage HBPM

A structured, telephone-based educational outreach to encourage HBPM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AdventHealth Winter Park

Orlando, Florida, 32792, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 29, 2026

Study Start

November 19, 2025

Primary Completion

April 8, 2026

Study Completion

April 8, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

email primary investigator

Locations