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.
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
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Barcelona、西班牙、08025
- Hospital de la Santa Creu i Sant Pau
-
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Clinical Practice Group
Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program.
|
Clinical practice group will not receive any specific education
|
其他:"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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其他:Intervention group
This group will receive a limited educational asthma program (minimal educational intervention)
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of asthma exacerbations
大体时间: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 number of asthma exacerbations.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
ACT score
大体时间: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
|
合作者和调查者
调查人员
- 学习椅:Antolin Lopez, MD、Hospital Universitario Puerta Hierro Madrid (Spain)
- 学习椅:Meritxell Peiro、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 学习椅:José M Ignacio, MD、Hospital Serrania de Ronda. Málaga (Spain).
- 学习椅:José A Quintano, MD、Centro de Salud Lucena I. Lucena. Córdoba (Spain).
- 学习椅:Santiago Bardagí, MD、Hospital de Mataró. Barcelona (Spain)
- 首席研究员:Vicente Plaza, MD、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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