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Cognitive Load and Inhaler Technique in COPD (DUAL-INH)

25. August 2026 aktualisiert von: Crisan Alexandru Florian, Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

Cognitive Load-Induced Inhaler Errors in COPD: Linking Dual-Task Mobility to Treatment Self-Management

This study evaluates whether cognitive load affects inhaler technique in adults with chronic obstructive pulmonary disease (COPD). During a single study visit, participants will complete assessments of cognitive function, mobility, and respiratory status. Dual-task mobility will be assessed using the Timed Up and Go test performed alone and while completing a cognitive task. Inhaler technique will then be evaluated in two conditions: usual inhaler use without an additional task and inhaler use while maintaining a short sequence of digits in working memory. Inhaler technique will be scored using a standardized five-step device-specific checklist, and inhaler use time will also be recorded. The study will examine whether inhaler technique worsens under cognitive load and whether this deterioration is associated with dual-task mobility performance, cognitive function, respiratory symptoms, and functional capacity. No inhaler training or correction will be provided between the two inhaler conditions. All assessments are performed during a single visit.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

  • Name: Alexandru Crișan
  • Telefonnummer: 0765525688
  • E-Mail: crisan@umft.ro

Studienorte

  • Rumänien
    • Timiș County
      • Timișoara, Timiș County, Rumänien, 300041
        • Rekrutierung
        • "Dr. Victor Babeș" Clinical Hospital of Infectious Diseases and Pneumophthisiology, Timișoara
        • 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:

  • Adults aged 18 years or older
  • Confirmed diagnosis of chronic obstructive pulmonary disease (COPD)
  • Clinically stable at the time of assessment
  • Current use of at least one handheld maintenance inhaler (pMDI, SMI, or DPI)
  • Able to understand and follow study instructions
  • Able to perform the Timed Up and Go test
  • Able to complete the cognitive tasks and inhaler technique assessment
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Recent COPD exacerbation with incomplete recovery to baseline clinical status
  • Acute respiratory or other acute medical condition at the time of assessment
  • Known severe cognitive impairment or dementia that prevents completion of study procedures
  • Neurological or musculoskeletal impairment that prevents safe completion of the Timed Up and Go test
  • Severe visual, hearing, or communication impairment that prevents completion of the cognitive or inhaler tasks
  • Inability to independently handle or use the study inhaler device for assessment purposes

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Single-Task Followed by Cognitive Dual-Task
Participants first perform inhaler use under the single-task condition, without a concurrent cognitive task. After a short rest and without any inhaler-technique training or correction, they perform inhaler use under a working-memory cognitive load. In both conditions, inhaler technique is scored using the same standardized five-item device-specific checklist and inhaler-use time is recorded.
Verhalten: Working-Memory Cognitive Load During Inhaler Use
Participants are presented with a standardized five-digit sequence before inhaler use and are instructed to retain the sequence in working memory while completing their usual inhaler technique. The sequence is presented once at approximately one digit per second. Participants do not verbalize the digits during inhaler use. Immediately after completing the inhaler maneuver, they reproduce the sequence in reverse order. Inhaler technique is simultaneously assessed using a standardized five-item device-specific checklist, and inhaler-use time is recorded.
Verhalten: Single-Task Inhaler Use
Participants use their usual maintenance inhaler without a concurrent cognitive task. They are instructed to use the inhaler as they normally do at home. Inhaler technique is assessed using the same standardized five-item device-specific checklist, and inhaler-use time is recorded. No inhaler-technique training, correction, or feedback is provided before completion of both study conditions.
Experimental: Cognitive Dual-Task Followed by Single-Task
Participants first perform inhaler use under a working-memory cognitive load. After a short rest and without any inhaler-technique training or correction, they perform inhaler use under the single-task condition without a concurrent cognitive task. In both conditions, inhaler technique is scored using the same standardized five-item device-specific checklist and inhaler-use time is recorded.
Verhalten: Working-Memory Cognitive Load During Inhaler Use
Participants are presented with a standardized five-digit sequence before inhaler use and are instructed to retain the sequence in working memory while completing their usual inhaler technique. The sequence is presented once at approximately one digit per second. Participants do not verbalize the digits during inhaler use. Immediately after completing the inhaler maneuver, they reproduce the sequence in reverse order. Inhaler technique is simultaneously assessed using a standardized five-item device-specific checklist, and inhaler-use time is recorded.
Verhalten: Single-Task Inhaler Use
Participants use their usual maintenance inhaler without a concurrent cognitive task. They are instructed to use the inhaler as they normally do at home. Inhaler technique is assessed using the same standardized five-item device-specific checklist, and inhaler-use time is recorded. No inhaler-technique training, correction, or feedback is provided before completion of both study conditions.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Inhaler Technique Performance Under Cognitive Load
Zeitfenster: During the single study visit, immediately after completion of both inhaler conditions
Difference in the number of satisfactory inhaler-technique steps between the cognitive dual-task condition and the single-task condition, assessed using the same standardized 5-item device-specific inhaler technique checklist. Each checklist item is scored as 1 = satisfactory or 0 = unsatisfactory/omitted, yielding a total score of 0 to 5 for each condition. The primary outcome is calculated as dual-task satisfactory score minus single-task satisfactory score, with a possible range from -5 to +5. Negative values indicate deterioration of inhaler technique under cognitive load.
During the single study visit, immediately after completion of both inhaler conditions

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
New Inhaler Error Under Cognitive Load
Zeitfenster: During the single study visit, immediately after completion of both inhaler conditions
Binary outcome indicating whether inhaler technique deteriorates under cognitive load. A new inhaler error is defined as having fewer satisfactory items on the standardized 5-item inhaler technique checklist during the cognitive dual-task condition than during the single-task condition. Coded as 1 = deterioration under cognitive load and 0 = no deterioration.
During the single study visit, immediately after completion of both inhaler conditions
Worsening of Inhaler Technique Classification Under Cognitive Load
Zeitfenster: During the single study visit, immediately after completion of both inhaler conditions
Binary outcome indicating whether the participant's inhaler technique classification worsens from Acceptable during the single-task condition to Unacceptable during the cognitive dual-task condition. Inhaler technique is classified using the standardized 5-item checklist, with 4-5 satisfactory steps classified as Acceptable and 0-3 satisfactory steps classified as Unacceptable. Coded as 1 = classification worsened and 0 = no worsening.
During the single study visit, immediately after completion of both inhaler conditions
Inhaler Time Dual-Task Cost
Zeitfenster: During the single study visit, immediately after completion of both inhaler conditions
Percentage change in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as [(dual-task inhaler time - single-task inhaler time) / single-task inhaler time] × 100. Positive values indicate slower inhaler use under cognitive load.
During the single study visit, immediately after completion of both inhaler conditions
Inhaler Cognitive Dual-Task Cost
Zeitfenster: During the single study visit, immediately after completion of the inhaler cognitive assessments
Percentage change in working-memory performance between the cognitive single-task condition and the inhaler cognitive dual-task condition. It is calculated as [(single-task cognitive accuracy - dual-task cognitive accuracy) / single-task cognitive accuracy] × 100. Positive values indicate poorer cognitive performance while using the inhaler under cognitive load.
During the single study visit, immediately after completion of the inhaler cognitive assessments
Physical Dual-Task Cost During Timed Up and Go
Zeitfenster: During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
Percentage increase in Timed Up and Go completion time during the cognitive dual-task condition compared with the single-task condition. It is calculated as [(TUG dual-task time - TUG single-task time) / TUG single-task time] × 100. Positive values indicate slower mobility performance during dual-tasking.
During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
Cognitive Dual-Task Cost During Timed Up and Go
Zeitfenster: During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
Percentage reduction in cognitive performance during the dual-task Timed Up and Go condition compared with the cognitive single-task condition. Cognitive performance is quantified using the rate of correct responses per second. The outcome is calculated as [(single-task correct-response rate - dual-task correct-response rate) / single-task correct-response rate] × 100. Positive values indicate poorer cognitive performance during dual-task walking.
During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
Change in Inhaler Completion Time Under Cognitive Load
Zeitfenster: During the single study visit, immediately after completion of both inhaler conditions
Absolute difference in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as dual-task inhaler time minus single-task inhaler time, expressed in seconds. Positive values indicate longer inhaler-use time under cognitive load.
During the single study visit, immediately after completion of both inhaler conditions

Mitarbeiter und Ermittler

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

Sponsor

Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

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 (Tatsächlich)

21. August 2026

Primärer Abschluss (Geschätzt)

30. September 2027

Studienabschluss (Geschätzt)

30. November 2027

Studienanmeldedaten

Zuerst eingereicht

21. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. August 2026

Zuerst gepostet (Tatsächlich)

25. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • COPD-DT-INHALER-2026-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be made publicly available. De-identified data may be provided by the corresponding investigator upon reasonable request, subject to approval by the study team and, where required, the relevant ethics committee and institutional data-protection requirements.

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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