Cognitive Load and Inhaler Technique in COPD (DUAL-INH)
2026年8月25日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Alexandru Crișan
- 電話番号：0765525688
- メール：crisan@umft.ro
研究場所
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Timiș County
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Timișoara、Timiș County、ルーマニア、300041
- 募集
- "Dr. Victor Babeș" Clinical Hospital of Infectious Diseases and Pneumophthisiology, Timișoara
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コンタクト：
- Alexandru Crișan
- 電話番号：0765525688
- メール：crisan@umft.ro
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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.
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実験的：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.
|
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.
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Inhaler Technique Performance Under Cognitive Load
時間枠：During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
New Inhaler Error Under Cognitive Load
時間枠：During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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Worsening of Inhaler Technique Classification Under Cognitive Load
時間枠：During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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Inhaler Time Dual-Task Cost
時間枠：During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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Inhaler Cognitive Dual-Task Cost
時間枠：During the single study visit, immediately after completion of the inhaler cognitive assessments
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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.
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During the single study visit, immediately after completion of the inhaler cognitive assessments
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Physical Dual-Task Cost During Timed Up and Go
時間枠：During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
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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.
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During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments
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Cognitive Dual-Task Cost During Timed Up and Go
時間枠：During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
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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.
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During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments
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Change in Inhaler Completion Time Under Cognitive Load
時間枠：During the single study visit, immediately after completion of both inhaler conditions
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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.
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During the single study visit, immediately after completion of both inhaler conditions
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月21日
一次修了 (推定)
2027年9月30日
研究の完了 (推定)
2027年11月30日
試験登録日
最初に提出
2026年8月21日
QC基準を満たした最初の提出物
2026年8月21日
最初の投稿 (実際)
2026年8月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月26日
QC基準を満たした最後の更新が送信されました
2026年8月25日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- COPD-DT-INHALER-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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