- ICH GCP
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- Klinische proef NCT01282359
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
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Barcelona, Spanje, 08025
- Hospital de La Santa Creu i Sant Pau
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: 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
|
|
Ander: "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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Ander: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of asthma exacerbations
Tijdsspanne: 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.
|
1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
ACT score
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Antolin Lopez, MD, Hospital Universitario Puerta Hierro Madrid (Spain)
- Studie stoel: Meritxell Peiro, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Studie stoel: José M Ignacio, MD, Hospital Serrania de Ronda. Málaga (Spain).
- Studie stoel: José A Quintano, MD, Centro de Salud Lucena I. Lucena. Córdoba (Spain).
- Studie stoel: Santiago Bardagí, MD, Hospital de Mataró. Barcelona (Spain)
- Hoofdonderzoeker: Vicente Plaza, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIBSP-PRO-2010-16
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