Personalised Outcomes in Children With Recurrent Wheeze
Validation of a Patient-reported Outcome Measurement Tool
This project aims to develop a PROM for preschool children with recurrent wheeze. Nearly one third of children will have at least one episode of wheeze in the first five years of life. The majority of these children grow out of the condition in early school years. However, their families go through challenging times often with numerous emergency department admissions and hospitalizations. Hospital admission rates for preschool children with wheeze attacks remain high and are increasing in the UK. New treatments have become available, but although current treatments speed recovery from a wheeze attack, still many children visit hospitals for rescue medications and medical reviews. Recent Australian data show that one fourth of these children remain at emergency departments for a less than four hours period, suggesting that with better information and education, these children could have remained at home.
Justification-Significance of the work By understanding what really matters for these families, clinicians and stakeholders will be better able to design interventions that will reduce the hospital attendances and admissions by empowering parents to manage their children's condition. More specifically, this tool will assist GPs identify which of these children need to be reviewed by specialists, aid holistic management, ensure interventions are meaningful for families and assess the benefits of novel treatments.
Methodology The items of the questionnaire have been generated through discussions with families in a qualitative research study conducted by the research team. These items will be refined and the questionnaire will be tested with families in different healthcare settings. Researchers will assess how well this questionnaire is identifying the children who present with greater number of hospital admissions and will be benefited from suggested interventions. The data will be analysed and based on the results, amendments will be made to the questionnaire, which can will then be introduced in the routine management of these children.
調査の概要
詳細な説明
The validation of the tool will take place at St Mary's Hospital.
The questionnaire aims to measure
- incidence of wheeze attacks and use of rescue medications
- parental/caregiver perception of recurrent wheeze control
- parental/caregiver perception of effect of recurrent wheeze on family/child quality of life
Participants will be given the questionnaire at the emergency departments or outpatients clinics following having consented to the study and will be asked to fill in the questionnaire and return it to their clinician.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Heidi Makrinioti
- 電話番号:07771348633
- メール:heidimakrinioti@gmail.com
研究場所
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London、イギリス、W2 1NY
- 募集
- St Mary's Hospital
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コンタクト:
- ChaidoNiki Makrynioti, PhD
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
In this study caregivers of preschool children presenting with the second or more episode of wheeze that requires physician review with or without treatment (as per BTS definition of wheeze attack in preschool years) will be included.
Exclusion Criteria:
This study will exclude caregivers who do not consent to complete the questionnaire and therefore participate in the study.
This study will exclude caregivers of preschool children who present with their first episode of wheeze.
This study will exclude caregivers of preschool children who present with respiratory distress of any other etiology (foreign body inhalation, croup, lower respiratory tract infection, bronchiectasis, exacerbation of cystic fibrosis or ciliopathy)
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
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 |
|---|---|---|
|
feasibility of preschool wheeze assessment tool
時間枠:March 2019 - March 2020
|
how easily the questionnaire can be completed
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March 2019 - March 2020
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content validity of the questionnaire
時間枠:March 2019-March 2020
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assessing validity of each item of the questionnaire as comparing with item of already existing questionnaire
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March 2019-March 2020
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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 |
|---|---|---|
|
reduction of avoidable emergency department admissions
時間枠:March 2020-March 2021
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effect of the tool on number of avoidable emergency department presentations
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March 2020-March 2021
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協力者と研究者
捜査官
- 主任研究者:Mando Watson、Imperial College Healthcare NHS Trust
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 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。