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NCT07693699NARecruiting

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care

Wake Forest University Health Sciences

Start Date

7/30/2026

Completion Date

11/20/2026

Summary

The goal of this study is to identify what cuff delivery and BP log return modality most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?

Detailed Description

The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders/support, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices. In addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials. Patients will be randomized to one of four arms: 1. Mail-order cuff delivery with enhanced return conversation 2. Mail-order cuff delivery with written instructions 3. In-clinic cuff distribution with enhanced return conversation 4. In-clinic cuff distribution with written instructions All other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age 18 years or older. * Diagnosed hypertension documented prior to the index clinic visit. * Scheduled for and attends an in-person visit with a participating clinician at a study clinic. * Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP \>=140 mmHg or diastolic BP \>=90 mmHg. Exclusion Criteria: * Visit is canceled, rescheduled, or the patient does not attend the visit. * Patient already has a usable home BP cuff provide through insurance within the past 5 years. * Patient declines assistance obtaining a BP cuff. * Patient declines submitting cuff order to insurance. * Patient unable to participate for operational reasons.

Interventions

BEHAVIORAL

In-Clinic Cuff Delivery - Enhanced Return Conversation

BEHAVIORAL

In-Clinic Cuff Delivery - Written Instructions

BEHAVIORAL

Mail Order Cuff Delivery - Enhanced Return Conversation

BEHAVIORAL

Mail Order Cuff Delivery - Written Instructions

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Conditions

Hypertension

Locations

Advocate Medical Group Chicago (Southeast)

Chicago, Illinois 60617

United States

Advocate Medical Group Chicago (Imani Village)

Chicago, Illinois 60619

United States

Advocate Medical Group Beverly

Chicago, Illinois 60643

United States

Advocate Medical Group Merrionette Park

Merrionette Park, Illinois 60803

United States

Advocate Medical Group Oak Lawn (FP)

Oak Lawn, Illinois 60453

United States

Advocate Medical Group Oak Lawn (IM)

Oak Lawn, Illinois 60453

United States