Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention (PROMETEO)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Other: Clinical practice group Other: "Gold Standard" educational group Other: Intervention group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention |
- Number of asthma exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 250 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 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
|
|
Experimental: "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
|
|
Experimental: Intervention group
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.
|
Detailed Description:
Method. A prospective, multicentre, centre randomized ("clusters analysis"), controlled, designed to evaluate the efficacy (reduction of exacerbations) and control degree control (increased ACT score) of an asthma educational program based on a limited intervention in patients with mild to moderate persistent asthma with an ACT <20. The cases included will be distributed into three arms: the intervention group, who will take the limited educational asthma program; clinical practice group, who will not receive any specific education; and education "gold standard" group, which will receive a formal program of structured and individualized education. 250 cases will be including from 25 Spanish centres (pulmonary and primary care): 10 allocated to the intervention group, 10 clinical practice group, and 5 of the gold standard group. Each centre will enrol 10 patients and will be followed for a year in four programmed visits. At baseline and at follow-up visits, will be collected in each patient: ACT score, the number of emergency room visits, unscheduled visits, hospital admissions, cycles of oral prednisone (> 15 days), compliance level, spirometric values and daily dose of inhaled corticosteroid (microg. or equivalent per day). Patients in the intervention group will receive 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Vicente Plaza, MD | + 3435565964 ext 5960 | vplaza@santpau.cat |
| Contact: Claudia E Delgado, MD | +3435537634 ext 7634 | cdelgadoe@santpau.cat |
| Spain | |
| Hospital de la Santa Creu i Sant Pau | Not yet recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Vicente Plaza, MD +3435565964 ext 5960 vplaza@santpau.cat | |
| Sub-Investigator: Meritxell Peiro, nurse | |
| Study Chair: | Antolin Lopez, MD | Hospital Universitario Puerta Hierro Madrid (Spain) |
| Study Chair: | Meritxell Peiro | Hospital de la Santa Creu i Sant Pau, Barcelona, Spain |
| 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 | Hospital de la Santa Creu i Sant Pau, Barcelona, Spain |
More Information
Publications:
| Responsible Party: | Vicente Plaza MD, Hospital de la Santa Creu i Sant Pau |
| ClinicalTrials.gov Identifier: | NCT01282359 History of Changes |
| Other Study ID Numbers: | IIBSP-PRO-2010-16 |
| Study First Received: | January 19, 2011 |
| Last Updated: | January 28, 2011 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
|
Educational asthma program Clusters analysis study Asthma Control Test |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013