A Comprehensive Care Programme for Patients With Chronic Obstructive Pulmonary Disease
調査の概要
詳細な説明
Design: A randomised controlled trial of patients discharged from hospital after an episode of acute exacerbation of COPD. Patients will be randomised to the intervention arm or usual care group.
Setting: Tertiary University affiliated Hospital.
Interventions:
The Intervention group will receive a comprehensive programme which involves inputs from doctors, respiratory nurses and physiotherapists, providing an individualized care plan for each subject. The components in the programme will include optimization of medications, specialist physician follow up, nursing support in education, and physiotherapist support for pulmonary rehabilitation. Patients in the intervention group will also receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and answer their queries. Patients will also be followed up in the respiratory clinic by respiratory specialist once every 3 months for 1 year.
The control group will be managed as the usual care. The discharging physician will determine the patients' medication and follow up as in normal practice.
All patients will be asked to return for assessments (spirometry, 6 minute walk test, questionnaires on the severity of dyspnoea and quality of life) at baseline and 12 months
Main outcome measures: The primary endpoint is the hospital readmission rate and the secondary endpoints are the quality of life, mortality, lung function and exercise capacity of the patients.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Hong Kong、香港
- The Chinese University of Hong Kong
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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:
- Patients who are admitted to the Prince of Wales Hospital with AECOPD will be screened for this study.
- Patients with age over 40 years
Exclusion Criteria:
- Patients with asthma
- Patients unable to provide informed consent
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：処理
- 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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アクティブコンパレータ：comprehensive care programme
Comprehensive care involving multidisciplinary input.
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Intervention group:
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介入なし：Control group
Control arm with usual care
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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 |
|---|---|---|
|
Hospital Readmission
時間枠：12 months
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To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.
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12 months
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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 |
|---|---|---|
|
Quality of Life
時間枠：12 months
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Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month.
SGRQ total score ranged from 0-100.
The change was calculated by the 12 month SGRQ total score minus the baseline value.
Negative values indicated improvement in quality of life.
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12 months
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Mortality
時間枠：12 months
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From contacting the patient/their family and hospital record retrieval.
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12 months
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Lung Function
時間枠：12 months
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Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month.
The range is from 0% to 100%.
The change was calculated by 12 month value minus the baseline value.
Positive value indicated improvement in lung function.
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12 months
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Exercise Capacity
時間枠：12 month
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Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month.
6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters.
This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline.
Positive values indicated improvement in exercise capacity.
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12 month
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協力者と研究者
捜査官
- スタディディレクター：David S Hui, MD、Chinese University of Hong Kong
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 (実際)
研究の完了 (実際)
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 (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
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