Cognitive Load and Inhaler Technique in COPD

ConditionCOPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSpitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Working-Memory Cognitive Load During Inhaler Use

    Behavioral

    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.

  • Single-Task Inhaler Use

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Single-Task Followed by Cognitive Dual-TaskExperimental treatment 2 interventions
Group B: Cognitive Dual-Task Followed by Single-TaskExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Inhaler Technique Performance Under Cognitive Load

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.

Time frame
During the single study visit, immediately after completion of both inhaler conditions

Secondary outcomes

1

New Inhaler Error Under Cognitive Load

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.

Time frame
During the single study visit, immediately after completion of both inhaler conditions
2

Worsening of Inhaler Technique Classification Under Cognitive Load

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.

Time frame
During the single study visit, immediately after completion of both inhaler conditions
3

Inhaler Time Dual-Task Cost

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.

Time frame
During the single study visit, immediately after completion of both inhaler conditions
4

Inhaler Cognitive Dual-Task Cost

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.

Time frame
During the single study visit, immediately after completion of the inhaler cognitive assessments

Other outcomes

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