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Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention (PROMETEO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282359
First Posted: January 25, 2011
Last Update Posted: September 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 250
Study Start Date: October 2011
Study Completion Date: September 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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


Locations
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sociedad Española de Neumología y Cirugía Torácica
Investigators
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
  More Information

Publications:
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01282359     History of Changes
Other Study ID Numbers: IIBSP-PRO-2010-16
First Submitted: January 19, 2011
First Posted: January 25, 2011
Last Update Posted: September 16, 2015
Last Verified: September 2015

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