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

NCT01282359 | Completed Phase 4 DMC

• 1 other identifier: IIBSP-PRO-2010-16
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Educational asthma program; Clusters analysis study; Asthma Control Test

Outcome Measures

Primary Outcomes (1)

• Number of asthma exacerbations

  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.

  1 year

Secondary Outcomes (1)

• ACT score

  1 year

Study Arms (3)

Clinical Practice Group

OTHER

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

Other: Clinical practice group

"Gold Standard" educational group

OTHER

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

Other: "Gold Standard" educational group

Intervention group

OTHER

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

Other: Intervention group

Interventions

Clinical practice group OTHER

Clinical practice group will not receive any specific education

Clinical Practice Group

"Gold Standard" educational group OTHER

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

"Gold Standard" educational group

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe exacerbation of asthma (which required emergency room visit and/or hospitalization) within 30 days prior to visit 1.
• Severe disabling comorbidity.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Related Publications (3)

• 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.

  PMID: 17257561 BACKGROUND

• 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.

  PMID: 19711653 BACKGROUND

• 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.

  PMID: 15690558 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Antolin Lopez, MD

  Hospital Universitario Puerta Hierro Madrid (Spain)

  STUDY CHAIR

• Meritxell Peiro

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

  STUDY CHAIR

• José M Ignacio, MD

  Hospital Serrania de Ronda. Málaga (Spain).

  STUDY CHAIR

• José A Quintano, MD

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

  STUDY CHAIR

• Santiago Bardagí, MD

  Hospital de Mataró. Barcelona (Spain)

  STUDY CHAIR

• Vicente Plaza, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 25, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

ES (1)