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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention

Conditions
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Asthma

Intervention / Treatment
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* Other: Clinical practice group
* Other: Gold Standard educational group
* Other: Intervention group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical Practice Group<br>Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program. | Other: Clinical practice group<br>* Clinical practice group will not receive any specific education<br>|
| Other: Gold Standard educational group<br>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<br>* Gold Standard educational group will receive a formal program of structured and individualized education<br>|
| Other: Intervention group<br>This group will receive a limited educational asthma program (minimal educational intervention) | Other: Intervention group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Educational asthma program, Clusters analysis study, Asthma Control Test