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

2. Juli 2026 aktualisiert von: 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 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?

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60617
        • Advocate Medical Group Chicago 2301 93rd (Southeast)
        • Kontakt:
      • Chicago, Illinois, Vereinigte Staaten, 60619
        • Advocate Medical Group Chicago (Imani Village)
        • Kontakt:
      • Oak Lawn, Illinois, Vereinigte Staaten, 60453
        • Advocate Medical Group Oak Lawn
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Mail-order cuff delivery - Hands-on training
Patients will receive a blood pressure cuff in the mail and receive hands on training.
Verhalten: Mail Order Cuff Delivery - Hands-on Training
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.
Aktiver Komparator: Mail-order cuff delivery - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training.
Verhalten: Mail Order Cuff Delivery - Written Instructions
Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.
Aktiver Komparator: In-clinic cuff distribution - Hands-on training
Patients will receive a blood pressure cuff in the clinic and receive hands on training.
Verhalten: In-Clinic Cuff Delivery - Hands-on Training
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.
Aktiver Komparator: In-clinic cuff distribution - Written instructions
Patients will receive a blood pressure cuff in the mail and receive written training.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of Blood Pressure Receipt
Zeitfenster: 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 Training Completion
Zeitfenster: up to day 14
Number of participants that completed the assigned training modality as documented on the envelope checklist.
up to day 14
Rate of Cuff Order Completion
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to Complete Intervention
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
up to day 14
Rate of Fidelity
Zeitfenster: 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.
up to day 14
Rate of Differential Implementation Success
Zeitfenster: up to day 14
Number of participants with successful delivery of both blood pressure cuff and training.
up to day 14

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Systolic Blood Pressure
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Ermittler

  • Hauptermittler: Rasha Khatib, PhD, Advocate Health

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Juli 2026

Primärer Abschluss (Geschätzt)

20. Oktober 2026

Studienabschluss (Geschätzt)

20. November 2026

Studienanmeldedaten

Zuerst eingereicht

2. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

9. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00151173

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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