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

NCT07693699 | Not Yet Recruiting

• 1 other identifier: IRB00151173
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to identify what cuff delivery and training strategies 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

Keywords

blood pressure cuff; blood pressure cuff delivery; blood pressure cuff instruction

Outcome Measures

Primary Outcomes (3)

• Rate of Blood Pressure Receipt

  Number of participants that have received their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available

  up to day 14

• Rate of Training Completion

  Number of participants that completed the assigned training modality as documented on the envelope checklist.

  up to day 14

• Rate of Cuff Order Completion

  Number of participants that have ordered their blood pressure cuff documented through the envelope checklist, vendor records, or vendor delivery confirmation when available.

  up to day 14

Secondary Outcomes (6)

• Time to Complete Intervention

  up to day 14

• Number of Participants Documenting at Least One Blood Pressure Reading

  up to day 21

• Time Between Cuff Receipt and First Documented Reading

  up to day 21

• Rate of Workflow Barriers

  up to day 14

• Rate of Fidelity

  up to day 14

Other Outcomes (2)

• Change in Systolic Blood Pressure

  up to day 90

• Rate of Medication Intensification

  up to day 90

Study Arms (4)

Mail-order cuff delivery - Hands-on training

ACTIVE COMPARATOR

Patients will receive a blood pressure cuff in the mail and receive hands on training.

Behavioral: Mail Order Cuff Delivery - Hands-on Training

Mail-order cuff delivery - Written instructions

ACTIVE COMPARATOR

Patients will receive a blood pressure cuff in the mail and receive written training.

Behavioral: Mail Order Cuff Delivery - Written Instructions

In-clinic cuff distribution - Hands-on training

ACTIVE COMPARATOR

Patients will receive a blood pressure cuff in the clinic and receive hands on training.

Behavioral: In-Clinic Cuff Delivery - Hands-on Training

In-clinic cuff distribution - Written instructions

ACTIVE COMPARATOR

Patients will receive a blood pressure cuff in the mail and receive written training.

Behavioral: In-Clinic Cuff Delivery - Written Instructions

Interventions

In-Clinic Cuff Delivery - Hands-on Training BEHAVIORAL

Complete vendor form; provide blood pressure log/instructions; demonstrate self-measured blood pressure using sample cuff; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.

In-clinic cuff distribution - Hands-on training

In-Clinic Cuff Delivery - Written Instructions BEHAVIORAL

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

In-clinic cuff distribution - Written instructions

Mail Order Cuff Delivery - Hands-on Training BEHAVIORAL

Complete vendor form; provide blood pressure log/instructions; demonstrate self-measured blood pressure using sample cuff; submit vendor form for mail delivery; complete envelope checklist.

Mail-order cuff delivery - Hands-on training

Mail Order Cuff Delivery - Written Instructions BEHAVIORAL

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

Mail-order cuff delivery - Written instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (3)

Advocate Medical Group Chicago 2301 93rd (Southeast)

Chicago, Illinois, 60617, United States

Location

Advocate Medical Group Chicago (Imani Village)

Chicago, Illinois, 60619, United States

Location

Advocate Medical Group Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rasha Khatib, PhD

  Advocate Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasha Khatib, PhD

CONTACT

7086843691; Rasha.Alkhatib@aah.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)