Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care
1 other identifier
interventional
150
1 country
6
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jul 2026
Shorter than P25 for not_applicable hypertension
6 active sites
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
First Submitted
Initial submission to the registry
July 2, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedStudy Start
First participant enrolled
July 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 20, 2026
August 12, 2026
June 1, 2026
3 months
July 2, 2026
August 10, 2026
Conditions
Keywords
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 Return Modality Completion
Number of participants that completed the assigned return 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
- +1 more secondary outcomes
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 - Enhanced Return Conversation
ACTIVE COMPARATORPatients 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.
Mail-order cuff delivery - Written instructions
ACTIVE COMPARATORPatients 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.
In-clinic cuff distribution - Enhanced Return Conversation
ACTIVE COMPARATORPatients 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.
In-clinic cuff distribution - Written instructions
ACTIVE COMPARATORPatients 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
Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rasha Khatib, PhD
Advocate Health
Central Study Contacts
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 30, 2026
Primary Completion (Estimated)
October 20, 2026
Study Completion (Estimated)
November 20, 2026
Last Updated
August 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share