Preventing Repeat Hospitalisations in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INCA R-ACE)
2019年7月17日 更新者：Professor Richard Costello、Beaumont Hospital
Risk Factors for Re-exacerbation After a Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
The purpose of this study is to determine whether the investigators can predict which patients are at risk of a re-exacerbation of COPD within 30 and 90 days using changes in lung capacity during the initial exacerbation.
調査の概要
状態
完了
詳細な説明
Patients admitted to hospital with an acute exacerbation of COPD will be approached to participate in the study.
The investigators will analyse changes in lung capacity (through measurement of spirometry and inspiratory capacity) and physical activity level over the first three days of admission, at discharge and at a day 30 follow-up visit. The investigators will record quality of life and symptom scores at these time points and again at a day 90 telephone visit. Data relating to the patients overall health status -disease severity, co-morbidity, cognition, psychological status, home environment and adherence to inhaled medication will be collected. The investigators will look for any relationship between these changes and a further exacerbations within 30 and 90 days.
The central hypothesis of this proposal is that the clinical course following an exacerbation of COPD may be monitored through measurement of inspiratory capacity(IC), a marker of lung hyperinflation. Resolution of an exacerbation is related to an increase in inspiratory capacity above a threshold level of improvement, after which the risk of re-exacerbation within the subsequent 30 and 90 days is low. The investigators will assess the accuracy of IC as a predictor of exacerbation and the feasibility of measuring IC during the early stages of a COPD exacerbation.
研究の種類
観察的
入学 (実際)
207
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。
研究場所
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Dublin、アイルランド
- Beaumont Hospital
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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
35年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Patients admitted to hospital with an acute exacerbation of COPD
説明
Inclusion Criteria:
- Within 72 hours of admission with an Acute Exacerbation of COPD (AE COPD) defined as "an acute change in a patient's baseline dyspnoea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in therapy" as per ATS/ERS consensus guidelines[ ] where "a change in therapy" includes the following: Prescription of antibiotics and / or systemic steroids
- Diagnosis of COPD based on GOLD criteria
- Able to give informed consent
- Willing to participate in the study
Exclusion Criteria:
- Admission reason other than AE COPD or breathlessness primarily caused by another pathology
- Already enrolled in the study
- Receiving palliative care
- Severe cognitive impairment or psychological disorder that results in inability to give informed consent or complete investigations required for the study
- Physical impairment resulting in inability to complete physiological tests
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
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 |
時間枠 |
|---|---|
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The relationship between change in inspiratory capacity(IC), from admission with an exacerbation of COPD to hospital discharge, and the risk of 30-day and 90-day re-exacerbation is reduced.
時間枠：From admission to 90 days from hospitalisation with an exacerbation
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From admission to 90 days from hospitalisation with an exacerbation
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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 |
|---|---|---|
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Relationship between changes in IC and respiratory symptoms
時間枠：From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between changes in Forced Expiratory Volume in 1 second (FEV1) and respiratory symptoms
時間枠：From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between changes in Forced Vital Capacity and respiratory symptoms
時間枠：From admission to 30 days from hospitalisation with an exacerbation
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Medical Research Council(MRC) and Borg breathlessness scores and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in IC and quality of life scores
時間枠：From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FEV1 and quality of life scores
時間枠：From admission to 30 days from hospitalisation with an exacerbation
|
COPD Assessment Test (CAT) quality of life score and FEV1 will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
|
From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FVC and quality of life scores
時間枠：From admission to 30 days from hospitalisation with an exacerbation
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COPD Assessment Test (CAT) quality of life score and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in IC and gait speed
時間枠：From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and IC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between change in FEV1 and gait speed
時間枠：From admission to 30 days from hospitalisation with an exacerbation
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4 metre gait speed test and FEV1 will be measured will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
|
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Relationship between change in FVC and gait speed
時間枠：From admission to 30 days from hospitalisation with an exacerbation
|
4 metre gait speed test and FVC will be measured at hospitalisation with an exacerbation of COPD and at 30 days post exacerbation and correlated.
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From admission to 30 days from hospitalisation with an exacerbation
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Relationship between patient factors and subsequent exacerbation
時間枠：90 days from hospitalisation with an exacerbation
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The association between patient factors (to include baseline GOLD grade, Charlston co-morbidity index score, Katz index, Hospital Anxiety and Depression Scale (HADS) score, Montreal Cognitive Assessment (MOCA) score) and exacerbation in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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Time to re-exacerbation
時間枠：90 days from hospitalisation with an exacerbation
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90 days from hospitalisation with an exacerbation
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Sensitivity of vital capacity measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
時間枠：Day 3-7 of hospital admission
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Vital capacity will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Sensitivity of FEV1 measures taken with a bedside portable spirometer compared with those performed in the pulmonary function test laboratory
時間枠：Day 3-7 of hospital admission
|
FEV1 will be measured at the bedside with a portable spirometer and using gold standard spirometry in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Sensitivity of inspiratory capacity (IC) measured with a bedside portable spirometer and by the gold standard body plethysmography
時間枠：Day 3-7 of hospital admission
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IC will be measured at the bedside with a portable spirometer and by gold standard body plethysmography in a pulmonary function laboratory.
These two measurements will then be compared and correlated.
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Day 3-7 of hospital admission
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Change in vital capacity during an exacerbation and its relationship to re-exacerbation
時間枠：At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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Change in FEV1 during an exacerbation and its relationship to re-exacerbation
時間枠：At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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At days 1-3 of admission, hospital discharge and 30 days from hospitalisation with an exacerbation
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Relationship between Exacerbation factors and re-exacerbation
時間枠：90 days from hospitalisation with an exacerbation
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The association between exacerbation severity as determined by DECAF score, need for non-invasive ventilation or critical care, length of hospital stay in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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Relationship between Social and Environmental factors and subsequent exacerbation
時間枠：90 days from hospitalisation with an exacerbation
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The impact of patients social environment as determined by living conditions, presence of home supports, socioeconomic group in the entire cohort and in those who do and do not achieve a rise in IC compared to baseline values will be examined
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90 days from hospitalisation with an exacerbation
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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。
スポンサー
捜査官
- 主任研究者：Richard W Costello、Beaumont Hospital, Dublin, Ireland
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)
2015年10月1日
一次修了 (実際)
2017年7月1日
研究の完了 (実際)
2018年9月1日
試験登録日
最初に提出
2015年12月10日
QC基準を満たした最初の提出物
2015年12月30日
最初の投稿 (見積もり)
2016年1月1日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月18日
QC基準を満たした最後の更新が送信されました
2019年7月17日
最終確認日
2019年7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
- INCA-R-ACE
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