Discharge Coordinator Intervention in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Effects of Discharge Coordinator Intervention on Hospitalizations and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Clinical Trial
調査の概要
詳細な説明
This is a single-centre randomized controlled clinical trial to assess the effectiveness of discharge coordinator intervention compared to care as usual in patients with COPD.
The study is being conducted at University Clinic of Pulmonary and Allergic Diseases Golnik, Slovenia. Patients with suspicion of acute exacerbation of COPD will be screened at admission when they will be informed about study details. After explanations of concerns and questions that they might have, a signed informed consent will be collected. During 48 hours, patients will be included according to their eligibility. Main inclusion criteria are COPD stage II-IV according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, ability to perform phone contacts and availability for home visits. Patients will be excluded if in unstable or terminal stage of disease other than COPD, if they will die during hospitalization, or if unable to follow the study protocol.
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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Golnik、スロベニア、SI-4204
- University Clinic Golnik
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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:
- age >35 years
- acute exacerbation of COPD stage II-IV
- residence in the geographical area linked to the study hospital
- ability to communicate
- give written informed consent
Exclusion Criteria:
- diagnosis of cognitive impairment
- unstable or terminal disease other than COPD
- withdrawal of written informed consent before discharge
- inability of phone contact
- death during hospitalisation
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：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：Coordinated discharge
Patients will receive support by discharge coordinator for activities associated with discharge and immediate post-discharge care.
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In intervention group, a discharge coordinator contacts hospitalized patients the day after randomization.
During hospitalization, discharge coordinator visits are scheduled according to patients' problems and home-care needs.
At 48 hours after hospital discharge, a discharge coordinator calls patients by phone to check the process of adjustment to home environment and to inquire about additional needs patients might have.
Thereafter, phone contacts are scheduled according to the patients' needs and 7-10 days after the hospital discharge a home visit is performed by discharge coordinator, respectively.
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プラセボコンパレーター：Control
Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
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Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
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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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Number of patients hospitalized due to COPD worsening
時間枠：180 days
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A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD.
Endpoint will be adjudicated by Endpoint committee.
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180 days
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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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All-cause mortality
時間枠：180 days
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Mortality will be ascertained at the Central Population Registry.
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180 days
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Acute exacerbations of COPD
時間枠：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Time to hospitalization due to COPD worsening
時間枠：180 days
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A hospitalization is defined as an unplanned overnight stay in hospital (different date for admission and discharge) due to acute worsening of COPD.
Endpoint will be adjudicated by Endpoint committee.
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180 days
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Days alive and out of hospital
時間枠：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Health-related quality of life
時間枠：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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Health care costs
時間枠：180 days
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Endpoint will be adjudicated by Endpoint committee.
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180 days
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協力者と研究者
捜査官
- 主任研究者：Jerneja Farkas, MD, PhD、University of Ljubljana
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 (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
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
- Golnik-COPD-DC-1
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。