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

NCT ID: NCT01282359

Last Updated: 2015-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-09-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical Practice Group

Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program.

Group Type: OTHER

Clinical practice group

Intervention Type: OTHER

Clinical practice group will not receive any specific education

"Gold Standard" educational group

Patients will receive a formal program of structured and individualized education, enrolled in centres recognized by using high standard procedures in asthma education.

Group Type: OTHER

"Gold Standard" educational group

Intervention Type: OTHER

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

Intervention group

This group will receive a limited educational asthma program (minimal educational intervention)

Group Type: OTHER

Intervention group

Intervention Type: 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.

Interventions

Clinical practice group

Clinical practice group will not receive any specific education

Intervention Type: OTHER

"Gold Standard" educational group

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

Intervention Type: OTHER

Intervention 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antolin Lopez, MD

Role: STUDY_CHAIR

Hospital Universitario Puerta Hierro Madrid (Spain)

Meritxell Peiro

Role: STUDY_CHAIR

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

José M Ignacio, MD

Role: STUDY_CHAIR

Hospital Serrania de Ronda. Málaga (Spain).

José A Quintano, MD

Role: STUDY_CHAIR

Centro de Salud Lucena I. Lucena. Córdoba (Spain).

Santiago Bardagí, MD

Role: STUDY_CHAIR

Hospital de Mataró. Barcelona (Spain)

Vicente Plaza, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 17257561 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19711653 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15690558 (View on PubMed)

Other Identifiers

IIBSP-PRO-2010-16

Identifier Type: -

Identifier Source: org_study_id