Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients (ACDM-Maccabi)
Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
調査の概要
詳細な説明
The aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma. The intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the Jerusalem and the Lowland District of Maccabi Health Services in Israel.
The main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease.
Secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.
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
-
-
-
Bat-Yam、イスラエル
- Maccabi Pulmonary Clinic
-
Holon、イスラエル
- Maccabi Pulmonary Clinic
-
-
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:
- Men and women
- 40 years or older
- Having unstable COPD or Asthma
Exclusion Criteria:
- Significant LV dysfunction
- Other severe chronic morbidity compromising short-term survival
- Significant cognitive impairment or psychiatric disease
- Bedridden
- Homeless or no telephone connection
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 |
|---|---|
|
実験的：Disease Management
Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community
|
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
|
|
アクティブコンパレータ：Unual care
Care delivered by the primary practitioner with the advice of a consultant pulmonologist
|
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
|
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 |
|---|---|---|
|
Healthcare services utilization for acute exacerbations of pulmonary disease
時間枠：Every 6 months during 1-3 years' follow-up
|
The proportion of patients who, due to exacerbation of their COPD or asthma, have at least one out of hours visit to a "off-hour non-hospital based acute-care facilities", or a visit to a hospital emergency room, or a hospitalization within the two years of follow-up.
|
Every 6 months during 1-3 years' follow-up
|
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：Every 6 months during 1-3 years' follow-up
|
Health-related quality of life
|
Every 6 months during 1-3 years' follow-up
|
|
Pulmonary function tests
時間枠：Every 6 months during 1-3 years' follow-up
|
Pulmonary function tests
|
Every 6 months during 1-3 years' follow-up
|
|
Physical function
時間枠：Every 6 months during 1-3 years' follow-up
|
6-minutes walk test assessment
|
Every 6 months during 1-3 years' follow-up
|
|
Depression
時間枠：Every 6 months during 1-3 years' follow-up
|
PHQ-9 Questionnaire
|
Every 6 months during 1-3 years' follow-up
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Meir Raz, M.D.、Maccabi Healthcare Services, Israel
- スタディディレクター：Ofra Kalter - Leibovici, M.D.、Sheba medical center
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
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。