- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
-
Barcelona, Spanien, 08025
- Hospital de la Santa Creu i Sant Pau
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 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
|
Övrig: "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.
|
"Gold Standard" educational group will receive a formal program of structured and individualized education
|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of asthma exacerbations
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
ACT score
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Antolin Lopez, MD, Hospital Universitario Puerta Hierro Madrid (Spain)
- Studiestol: Meritxell Peiro, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Studiestol: José M Ignacio, MD, Hospital Serrania de Ronda. Málaga (Spain).
- Studiestol: José A Quintano, MD, Centro de Salud Lucena I. Lucena. Córdoba (Spain).
- Studiestol: Santiago Bardagí, MD, Hospital de Mataró. Barcelona (Spain)
- Huvudutredare: Vicente Plaza, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIBSP-PRO-2010-16
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