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Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
MurciaSalud
Consejeria de sanidad.Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
AstraZeneca
Information provided by:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:
NCT01380405
First received: June 22, 2011
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

Given the importance of the correct use of inhalers by patients with Chronic Obstructive Pulmonary Disease (COPD) for the appropriate treatment of the disease, the self-care programme which will be assessed will consist of an educational intervention on the correct use of inhalers.

For this aim, we have designed this study to assess the influence of both individualized and collective self care programmes about the correct use of inhalers improves the functional state of patients with COPD compared to when there is no educational intervention.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Behavioral: education intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of an Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients in Primary Care: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:

Primary Outcome Measures:
  • To analyze if there is an improvement in the Score of BODE test [ Time Frame: 15 days, 30 days, 6 months ] [ Designated as safety issue: No ]
    The score is obtained by adding the points together (0-3) for each of the following four variables: distance covered in the 6 minute walking test, forced expiratory volume in the first second in the forced spirometry test, score on the MRC dyspnea test and body mass index


Secondary Outcome Measures:
  • Six minute walking test [ Time Frame: 15 days, 30 days, 6 months ] [ Designated as safety issue: No ]
  • Medical Research Council Scale (MRC) to measure the level of dyspnea (Bestall y col). [ Time Frame: 15 days, 30 days, 6 months ] [ Designated as safety issue: No ]
  • Number of recurrences [ Time Frame: 15 days, 30 days, 6 months ] [ Designated as safety issue: No ]
  • Number of hospitalisations [ Time Frame: 15 days, 30 days, 6 months ] [ Designated as safety issue: No ]
  • Visual assessment scales of the use of inhalers [ Time Frame: 15 days, 30 days, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 864
Study Start Date: May 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: without health education
the normal practices without specific intervention
Experimental: individual health education
The study intervention is an individual education in the correct use of inhalers and it will be carried out in so-called "inhalation workshops". The room in which the inhalation workshop will be located has to meet the necessary comfort conditions for the patient to feel relaxed and be able to carry out learning. The lesson included inhalation devices, explanatory leaflets
Behavioral: education intervention

Individual or collective education interventions about the correct use of inhalers.

session in the management of inhalers in the collective or individual programmed.

Session individual: 2 session. 15 min for session. Session collective: 2 session. 30-40 min for session. Maximum 4 persons.

Experimental: health education group
The study intervention is education in group in the correct use of inhalers and it will be carried out in so-called "inhalation workshops". The room in which the inhalation workshop will be located has to meet the necessary comfort conditions for the patient to feel relaxed and be able to carry out learning. In addition to the necessary furniture and teaching material that will be required (slide projector, over-head-projector, projection screen, video, etc.), the physical space given over to this purpose should consist of an area in which material can be left which will be used to complete the teaching and patient information (inhalation devices, explanatory leaflets, small monographs, slides, etc.).
Behavioral: education intervention

Individual or collective education interventions about the correct use of inhalers.

session in the management of inhalers in the collective or individual programmed.

Session individual: 2 session. 15 min for session. Session collective: 2 session. 30-40 min for session. Maximum 4 persons.


Detailed Description:

One of the key aspects for treating COPD is therapy with inhalation devices. Regarding the correct use of these devices, the international evidence showing that inhalers are not properly used, and in Spain, to the point that the inhaled therapy will fail if it is not accompanied by health education.

More recent studies touch upon the importance of nurses, physicians and other medical staff teaching the correct use of the inhaler. Apart from education, other factors play an important role when it comes to using the inhaler correctly: sex, age, level of education, polymedicated patients who use several kinds of devices, patients who are not aware of their disease and, finally, what is called therapeutic non-fulfillment.

The first report of the effectiveness of a self care programme aimed at the acquisition of self care abilities and behavior change was by Worth. Unfortunately this pilot study was not controlled and only studied a small sample of patients with COPD. There were impressive reductions in the frequency of irritations and house visits by the GP, but no changes in pulmonary function were found.

Several clinical trials have been carried out to evaluate the effectiveness of education programmes and self care in COPD. In the Cochrane revision (up-date 2007), no conclusions could be drawn about the effectiveness of self-control due to the great diversity of variables measured in the few studies published. Based on the antecedents presented, it is evident that COPD is a disease which is difficult to control in daily clinical practice, and that this inadequate control has a significant impact not only on the health of the patient who has this disease, but also on society and the economy.

To improve the control of COPD, the Primary Care physician needs simple and fast intervention to allow him or her to objectively improve the level of control of the disease that these patients have. The objective of self care is to teach patients the necessary aptitudes to carry out specific medical regimes for the treatment of COPD, to guide patients in how to have healthy habits and to lend emotional support to patients to help control their disease

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

The inclusion criteria: A patient diagnosed with COPD undergoing chronic treatment with at least one inhaler in the last year. The criteria of having been prescribed at least 10 prescriptions for an inhaler in the year will be used. Age between 40 to 75 years.

And exclusion criteria: Asthma diagnosis, Serious or terminal illnesses, Limiting osteoarticular disease, Walking disability, Serious mental illnesses: Psychosis, Major depressive disorder, Neurosis, Addictions to drugs/alcohol, Displaced patients (not habitual residents), Pregnancy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380405

Contacts
Contact: MJ Hernandez-Martinez 0034968226468 Mariaj.hernandez22@carm.es

Locations
Spain
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia Recruiting
Murcia, Region de Murcia, Spain, 30003
Contact: J Judez-Gutierrez, MD    +34 968 359767    javier.judez@ffis.es   
Principal Investigator: A Lopez-Santiago, MD         
Sub-Investigator: MJ Hernandez-Martinez         
Sub-Investigator: MP Fernandez-del-rio, MD         
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
MurciaSalud
Consejeria de sanidad.Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
AstraZeneca
Investigators
Principal Investigator: A Lopez-Santiago, MD Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
  More Information

Additional Information:
MeSH  This link exits the ClinicalTrials.gov site
MeSH  This link exits the ClinicalTrials.gov site
MeSH  This link exits the ClinicalTrials.gov site

Publications:
Annesi- Maesano I. Epidemiology of chronic obstructive pulmonary disease. In: Siafakas NM, ed. Management of Chronic Obstructive Pulmonary Disease. 2006.

Responsible Party: Javier Júdez Gutiérrez, Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
ClinicalTrials.gov Identifier: NCT01380405     History of Changes
Other Study ID Numbers: BRISA II. EPOC-Inhaladores
Study First Received: June 22, 2011
Last Updated: June 23, 2011
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Inhalators
Education
Primary care

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014