Improving Asthma Treatment Using Inhaler Technology
This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse.
We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.
調査の概要
状態
条件
詳細な説明
The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators.
The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting.
We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management.
Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Nottinghamshire
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Nottingham、Nottinghamshire、イギリス、NG7 2UH
- 募集
- Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
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コンタクト：
- Ireti Adejumo
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months [i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months] patient reported.
- Doctor's diagnosis of asthma for at least 12 months
- On BTS step 2-5 treatment via MDI [monitoring devices to be utilised in the study are compatible with MDI inhalers]
- Use of own internet-enabled and compatible mobile phone
Exclusion Criteria:
- Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack Year History of smoking
- Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis
- Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')
研究計画
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：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ：Control
Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.
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Monitors inhaler use
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実験的：Active
Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
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Monitors inhaler use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
Mobile application software linked to inhaler casing
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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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Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period
時間枠：Upto 24 weeks (study duration)
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Co-primary endpoint
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Upto 24 weeks (study duration)
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Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period
時間枠：Upto 24 weeks (study duration)
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Co-primary endpoint
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Upto 24 weeks (study duration)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Patient acceptability via qualitative feedback with questionnaires
時間枠：Upto 24 weeks (study duration)
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Upto 24 weeks (study duration)
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協力者と研究者
協力者
捜査官
- 主任研究者：Dominick Shaw、University of Nottingham
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Inhaler casingの臨床試験
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Neutec Ar-Ge San ve Tic A.Ş引きこもった