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

Asthma Clinical Trial

— PROMETEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282359
• Other study ID #: IIBSP-PRO-2010-16
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2011
• Last updated: September 15, 2015
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2015
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Clinical practice group
Clinical practice group will not receive any specific education
• "Gold Standard" educational group
"Gold Standard" educational group will receive a formal program of structured and individualized education
• 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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	ACT score	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.	1 year	Yes