Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention (PROMETEO)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Clinical practice group
"Gold Standard" educational group
Intervention group
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring Educational asthma program, Clusters analysis study, Asthma Control Test
Eligibility 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.
Sites / Locations
- Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Clinical Practice Group
"Gold Standard" educational group
Intervention group
Arm Description
Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program.
Patients will receive a formal program of structured and individualized education, enrolled in centres recognized by using high standard procedures in asthma education.
This group will receive a limited educational asthma program (minimal educational intervention)
Outcomes
Primary Outcome Measures
Number of asthma exacerbations
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
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.
Full Information
NCT ID
NCT01282359
First Posted
January 19, 2011
Last Updated
September 15, 2015
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
1. Study Identification
Unique Protocol Identification Number
NCT01282359
Brief Title
Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention
Acronym
PROMETEO
Official Title
Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Educational asthma program, Clusters analysis study, Asthma Control Test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Practice Group
Arm Type
Other
Arm Description
Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program.
Arm Title
"Gold Standard" educational group
Arm Type
Other
Arm Description
Patients will receive a formal program of structured and individualized education, enrolled in centres recognized by using high standard procedures in asthma education.
Arm Title
Intervention group
Arm Type
Other
Arm Description
This group will receive a limited educational asthma program (minimal educational intervention)
Intervention Type
Other
Intervention Name(s)
Clinical practice group
Intervention Description
Clinical practice group will not receive any specific education
Intervention Type
Other
Intervention Name(s)
"Gold Standard" educational group
Intervention Description
"Gold Standard" educational group will receive a formal program of structured and individualized education
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of asthma exacerbations
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ACT score
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antolin Lopez, MD
Organizational Affiliation
Hospital Universitario Puerta Hierro Madrid (Spain)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Meritxell Peiro
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José M Ignacio, MD
Organizational Affiliation
Hospital Serrania de Ronda. Málaga (Spain).
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José A Quintano, MD
Organizational Affiliation
Centro de Salud Lucena I. Lucena. Córdoba (Spain).
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Santiago Bardagí, MD
Organizational Affiliation
Hospital de Mataró. Barcelona (Spain)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vicente Plaza, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17257561
Citation
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.
Results Reference
background
PubMed Identifier
19711653
Citation
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.
Results Reference
background
PubMed Identifier
15690558
Citation
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.
Results Reference
background
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Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention
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