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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01282359
Acronym
PROMETEO
Enrollment
250
Registered
2011-01-25
Start date
2011-10-31
Completion date
2013-09-30
Last updated
2015-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Educational asthma program, Clusters analysis study, Asthma Control Test

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.

Interventions

OTHERClinical practice group

Clinical practice group will not receive any specific education

OTHERGold Standard educational group

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

OTHERIntervention 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.

Sponsors

Sociedad Española de Neumología y Cirugía Torácica
CollaboratorOTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of asthma exacerbations1 yearPatients 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

MeasureTime frameDescription
ACT score1 yearPatients 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026