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Completed

NCT Number: NCT01282359

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical practice group

Other

Clinical practice group will not receive any specific education

"Gold Standard" educational group

Other

"Gold Standard" educational group will receive a formal program of structured and individualized education

Intervention group

Other

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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

Registry information

Acronym: PROMETEO

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2011
Registry last updated
Sep 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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