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

10 augustus 2026 bijgewerkt door: Wake Forest University Health Sciences

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

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?

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60617
        • Werving
        • Advocate Medical Group Chicago (Southeast)
        • Contact:
      • Chicago, Illinois, Verenigde Staten, 60619
        • Werving
        • Advocate Medical Group Chicago (Imani Village)
        • Contact:
      • Chicago, Illinois, Verenigde Staten, 60643
        • Werving
        • Advocate Medical Group Beverly
        • Contact:
      • Merrionette Park, Illinois, Verenigde Staten, 60803
        • Werving
        • Advocate Medical Group Merrionette Park
        • Contact:
      • Oak Lawn, Illinois, Verenigde Staten, 60453
        • Werving
        • Advocate Medical Group Oak Lawn (IM)
        • Contact:
      • Oak Lawn, Illinois, Verenigde Staten, 60453
        • Werving
        • Advocate Medical Group Oak Lawn (FP)
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: Mail Order Cuff Delivery - Written Instructions
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
Actieve vergelijker: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of Blood Pressure Receipt
Tijdsspanne: 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
up to day 14
Rate of Cuff Order Completion
Tijdsspanne: 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.
up to day 14
Rate of Return Modality Completion
Tijdsspanne: up to day 14
Number of participants that completed the assigned return modality as documented on the envelope checklist.
up to day 14

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Complete Intervention
Tijdsspanne: up to day 14
Number of days from index clinic visit to documentation of both cuff receipt and completion of assigned training modality.
up to day 14
Number of Participants Documenting at Least One Blood Pressure Reading
Tijdsspanne: 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.
up to day 21
Time Between Cuff Receipt and First Documented Reading
Tijdsspanne: up to day 21
Number of days between cuff receipt and first documented self-monitored blood pressure reading.
up to day 21
Rate of Workflow Barriers
Tijdsspanne: 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, return modality not completed, missing documentation, clinic cuff inventory depletion, supply limitations, or other workflow disruptions identified through routine workflow documentation or operational follow-up activities.
up to day 14
Rate of Fidelity
Tijdsspanne: up to day 14
Number of participants that received the assigned cuff delivery modality and assigned return modality without crossover, reassignment, or missing assigned workflow components.
up to day 14
Rate of Differential Implementation Success
Tijdsspanne: up to day 14
Number of participants with successful delivery of both blood pressure cuff and return modality.
up to day 14

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Systolic Blood Pressure
Tijdsspanne: up to day 90
Change in systolic blood pressure using routinely documented clinic blood pressure values in Epic.
up to day 90
Rate of Medication Intensification
Tijdsspanne: 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.
up to day 90

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wake Forest University Health Sciences

Onderzoekers

  • Hoofdonderzoeker: Rasha Khatib, PhD, Advocate Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juli 2026

Primaire voltooiing (Geschat)

20 oktober 2026

Studie voltooiing (Geschat)

20 november 2026

Studieregistratiedata

Eerst ingediend

2 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

9 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

10 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB00151173

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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