Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention (PROMETEO)
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|ClinicalTrials.gov Identifier: NCT01282359|
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : September 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: Clinical practice group Other: "Gold Standard" educational group Other: Intervention group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||September 2013|
Clinical Practice Group
Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program.
Other: Clinical practice group
Clinical practice group will not receive any specific education
"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.
Other: "Gold Standard" educational group
"Gold Standard" educational group will receive a formal program of structured and individualized education
This group will receive a limited educational asthma program (minimal educational intervention)
Other: Intervention group
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.
- Number of asthma exacerbations [ Time Frame: 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.
- ACT score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282359
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Study Chair:||Antolin Lopez, MD||Hospital Universitario Puerta Hierro Madrid (Spain)|
|Study Chair:||Meritxell Peiro||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|
|Study Chair:||José M Ignacio, MD||Hospital Serrania de Ronda. Málaga (Spain).|
|Study Chair:||José A Quintano, MD||Centro de Salud Lucena I. Lucena. Córdoba (Spain).|
|Study Chair:||Santiago Bardagí, MD||Hospital de Mataró. Barcelona (Spain)|
|Principal Investigator:||Vicente Plaza, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|