Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Clinical practice group; "Gold Standard" educational group; Intervention group
Intervention type(s): Other; Other; Other
Intervention description(s): Clinical practice group will not receive any specific education; "Gold Standard" educational group will receive a formal program of structured and individualized education; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Educational asthma program; Clusters analysis study; Asthma Control Test