Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention (PROMETEO)
The asthma clinical practice guidelines categorize with the highest evidence level the effectiveness of educational programs. However, health care professionals not regularly applied it. This may contribute to inadequate control of the disease. Consequently, their designs and implementation strategies should be reviewed.
Hypothesis. An asthma educational program based on a limited intervention, managed by professionals with minimal training in education, could provide a significant decrease in the morbidity of the disease.
Objective. Determine the effectiveness, in terms of prevention of exacerbations (future risk) and improved asthma control (current control) of an educational program based on a reduced or minimal intervention.
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Barcelona、スペイン、08025
- Hospital de La Santa Creu i Sant Pau
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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:
- Male and female asthma patients with mild or moderate persistent asthma after treatment according to criteria of the GINA2009.
- Aged 18 and under 70 years.
- With ACT (Asthma Control Test) <20 treated at the outpatient clinics of the participating centers.
Exclusion Criteria:
- Severe exacerbation of asthma (which required emergency room visit and/or hospitalization) within 30 days prior to visit 1.
- Severe disabling comorbidity.
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 |
|---|---|
|
他の:Clinical Practice Group
Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program.
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Clinical practice group will not receive any specific education
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他の:"Gold Standard" educational group
Patients will receive a formal program of structured and individualized education, enrolled in centres recognized by using high standard procedures in asthma education.
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"Gold Standard" educational group will receive a formal program of structured and individualized education
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他の:Intervention group
This group will receive a limited educational asthma program (minimal educational intervention)
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Intervention group will take the limited educational asthma program which have three parts: basic information, establishment and revision of a small Action Plan (MiniPlan) and training and review of the inhalation skill of the prescribed device.
Educators involved will attend a short workshop (6 h), where they will be trained in the program.
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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 |
|---|---|---|
|
Number of asthma exacerbations
時間枠:1 year
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Patients will be followed for a year in four programmed visits.
At baseline and at follow-up visits, will be collected in each patient the number of asthma exacerbations.
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1 year
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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 |
|---|---|---|
|
ACT score
時間枠:1 year
|
Patients will be followed for a year in four programmed visits.
At baseline and at follow-up visits, will be collected in each patient the Asthma Control Test score.
|
1 year
|
協力者と研究者
捜査官
- スタディチェア:Antolin Lopez, MD、Hospital Universitario Puerta Hierro Madrid (Spain)
- スタディチェア:Meritxell Peiro、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- スタディチェア:José M Ignacio, MD、Hospital Serrania de Ronda. Málaga (Spain).
- スタディチェア:José A Quintano, MD、Centro de Salud Lucena I. Lucena. Córdoba (Spain).
- スタディチェア:Santiago Bardagí, MD、Hospital de Mataró. Barcelona (Spain)
- 主任研究者:Vicente Plaza, MD、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
出版物と役立つリンク
一般刊行物
- Morell F, Genover T, Reyes L, Benaque E, Roger A, Ferrer J. [Monitoring of asthma outpatients after adapting treatment to meet international guidelines]. Arch Bronconeumol. 2007 Jan;43(1):29-35. doi: 10.1016/s1579-2129(07)60017-2. Spanish.
- Mansour ME, Rose B, Toole K, Luzader CP, Atherton HD. Pursuing perfection: an asthma quality improvement initiative in school-based health centers with community partners. Public Health Rep. 2008 Nov-Dec;123(6):717-30. doi: 10.1177/003335490812300608.
- Henry RL, Gibson PG, Vimpani GV, Francis JL, Hazell J. Randomized controlled trial of a teacher-led asthma education program. Pediatr Pulmonol. 2004 Dec;38(6):434-42. doi: 10.1002/ppul.20095.
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
その他の研究ID番号
- IIBSP-PRO-2010-16
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