Clinical trial NCT01282359: Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention
Official title: Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Educational asthma program
Clusters analysis study
Asthma Control Test
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2011-01-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of asthma exacerbations
timeFrame: 1 year
Secondary outcomes:
measure: ACT score
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Hospital Universitario Puerta Hierro Madrid (Spain)
name: Antolin Lopez, MD
role: STUDY_CHAIR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Meritxell Peiro
role: STUDY_CHAIR
affiliation: Hospital Serrania de Ronda. Málaga (Spain).
name: José M Ignacio, MD
role: STUDY_CHAIR
affiliation: Centro de Salud Lucena I. Lucena. Córdoba (Spain).
name: José A Quintano, MD
role: STUDY_CHAIR
affiliation: Hospital de Mataró. Barcelona (Spain)
name: Santiago Bardagí, MD
role: STUDY_CHAIR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Vicente Plaza, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.