Recruiting

Blood Pressure Monitoring

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07693699

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

In-Clinic Cuff Delivery - Enhanced Return Conversation

In-Clinic Cuff Delivery - Written Instructions

Mail Order Cuff Delivery - Enhanced Return Conversation

Mail Order Cuff Delivery - Written Instructions

Study Details

Brief 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?

Conditions

Hypertension

Study ID

NCT07693699

Start date

Jul 30, 2026

Status verified date

Jun, 2026

Completion date

Nov 20, 2026

Anticipated

Primary completion date

Oct 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Mail-order cuff delivery - Enhanced Return Conversation

Patients will receive a blood pressure cuff in the mail and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.

active comparator: Mail-order cuff delivery - Written instructions

Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.

active comparator: In-clinic cuff distribution - Enhanced Return Conversation

Patients will receive a blood pressure cuff in the clinic and have a conversation with the medical assistant on when and how to return their blood pressure log with the care team.

active comparator: In-clinic cuff distribution - Written instructions

Patients will receive a blood pressure cuff in the mail and receive written training on who and when to return their blood pressure log with the care team.

Interventions

In-Clinic Cuff Delivery - Enhanced Return Conversation

Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.

In-Clinic Cuff Delivery - Written Instructions

Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.

Mail Order Cuff Delivery - Enhanced Return Conversation

Complete vendor form; provide blood pressure log/instructions; discuss with patient how and when to return bp log; submit vendor form for mail delivery; complete envelope checklist.

Mail Order Cuff Delivery - Written Instructions

Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.

Primary outcome measure

  • Rate of Blood Pressure Receipt [ Time Frame: up to day 14 ]
  • Rate of Return Modality Completion [ Time Frame: up to day 14 ]
  • Rate of Cuff Order Completion [ Time Frame: up to day 14 ]

Central Contacts and Locations

Central contacts

Rasha Khatib, PhD

7086843691Rasha.Alkhatib@aah.org

Locations

Advocate Medical Group Chicago (Southeast)

Recruiting

Chicago, Illinois, United States, 60617

Contacts

Nicole Glowacki, MPH

708-684-3691nicole.glowacki@aah.org

Advocate Medical Group Chicago (Imani Village)

Recruiting

Chicago, Illinois, United States, 60619

Contacts

Nicole Glowacki, MPH

708-684-3691nicole.glowacki@aah.org

Advocate Medical Group Beverly

Recruiting

Chicago, Illinois, United States, 60643

Contacts

Nicole Glowacki, MPH

708-684-3691nicole.glowacki@aah.org

Advocate Medical Group Merrionette Park

Recruiting

Merrionette Park, Illinois, United States, 60803

Contacts

Nicole Glowacki, MPH

708-684-3691nicole.glowacki@aah.org

Advocate Medical Group Oak Lawn (FP)

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Nicole Glowacki, MPH

708-684-3691nicole.gowacki@aah.org

Advocate Medical Group Oak Lawn (IM)

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Nicole Glowacki, MPH

708-684-3691nicole.glowacki@aah.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 12, 2026

Last verified

Jun, 2026

Keywords

  • blood pressure cuff
  • blood pressure cuff delivery
  • blood pressure cuff instruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-12.