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NCT Number: NCT07693699

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Medical Group Chicago (Imani Village), Chicago, Illinois, United States

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About this study

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:

  • Mail-order cuff delivery with hands-on training
  • Mail-order cuff delivery with written instructions
  • In-clinic cuff distribution with hands-on training
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

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 - Written Instructions

Behavioral

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

Primary outcomes

  1. Rate of Blood Pressure Receipt

    Time frame: up to day 14

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

  2. Rate of Training Completion

    Time frame: up to day 14

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

  3. Rate of Cuff Order Completion

    Time frame: up to day 14

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

Secondary outcomes

  1. Time to Complete Intervention

    Time frame: up to day 14

    Number of days from index clinic visit to documentation of both cuff receipt and completion of assigned training modality.

  2. Number of Participants Documenting at Least One Blood Pressure Reading

    Time frame: up to day 21

    Number of participants with at least one self-monitored blood pressure reading documented in the EHR within 21 days of cuff receipt.

  3. Time Between Cuff Receipt and First Documented Reading

    Time frame: up to day 21

    Number of days between cuff receipt and first documented self-monitored blood pressure reading.

  4. Rate of Workflow Barriers

    Time frame: up to day 14

    Number of participants with documented workflow barriers contributing to incomplete or non-concordant intervention delivery, including shipment issues, incomplete vendor forms, patient decline after workflow initiation, training not completed, missing documentation, clinic cuff inventory depletion, supply limitations, or other workflow disruptions identified through routine workflow documentation or operational follow-up activities.

  5. Rate of Fidelity

    Time frame: up to day 14

    Number of participants that received the assigned cuff delivery modality and assigned training modality without crossover, reassignment, or missing assigned workflow components.

  6. Rate of Differential Implementation Success

    Time frame: up to day 14

    Number of participants with successful delivery of both blood pressure cuff and training.

Other outcomes

  1. Change in Systolic Blood Pressure

    Time frame: up to day 90

    Change in systolic blood pressure using routinely documented clinic blood pressure values in Epic.

  2. Rate of Medication Intensification

    Time frame: up to day 90

    Number of participants with addition of a new antihypertensive medication class, dose increase, or regimen intensification consistent with clinician-directed care using Epic medication order data.

Study contacts

Contact information is provided by the study sponsor or research team.

Rasha Khatib, PhD

CONTACT

[email protected]

7086843691

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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