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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
education intervention
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Inhalators, Education, Primary care

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

without health education

individual health education

health education group

Arm Description

the normal practices without specific intervention

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

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.).

Outcomes

Primary Outcome Measures

To analyze if there is an improvement in the Score of BODE test
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
Medical Research Council Scale (MRC) to measure the level of dyspnea (Bestall y col).
Number of recurrences
Number of hospitalisations
Visual assessment scales of the use of inhalers

Full Information

First Posted
June 22, 2011
Last Updated
December 14, 2017
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
MurciaSalud, Public Health Service, Murcia, AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01380405
Brief Title
Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Effectiveness of an Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients in Primary Care: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
MurciaSalud, Public Health Service, Murcia, AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Inhalators, Education, Primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
without health education
Arm Type
No Intervention
Arm Description
the normal practices without specific intervention
Arm Title
individual health education
Arm Type
Experimental
Arm Description
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
Arm Title
health education group
Arm Type
Experimental
Arm Description
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.).
Intervention Type
Behavioral
Intervention Name(s)
education intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
To analyze if there is an improvement in the Score of BODE test
Description
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
Time Frame
15 days, 30 days, 6 months
Secondary Outcome Measure Information:
Title
Six minute walking test
Time Frame
15 days, 30 days, 6 months
Title
Medical Research Council Scale (MRC) to measure the level of dyspnea (Bestall y col).
Time Frame
15 days, 30 days, 6 months
Title
Number of recurrences
Time Frame
15 days, 30 days, 6 months
Title
Number of hospitalisations
Time Frame
15 days, 30 days, 6 months
Title
Visual assessment scales of the use of inhalers
Time Frame
15 days, 30 days, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Lopez-Santiago, MD
Organizational Affiliation
Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
City
Murcia
State/Province
Region De Murcia
ZIP/Postal Code
30003
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
Annesi- Maesano I. Epidemiology of chronic obstructive pulmonary disease. In: Siafakas NM, ed. Management of Chronic Obstructive Pulmonary Disease. 2006.
Results Reference
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PubMed Identifier
10330536
Citation
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Results Reference
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PubMed Identifier
19553233
Citation
Miravitlles M, Soriano JB, Garcia-Rio F, Munoz L, Duran-Tauleria E, Sanchez G, Sobradillo V, Ancochea J. Prevalence of COPD in Spain: impact of undiagnosed COPD on quality of life and daily life activities. Thorax. 2009 Oct;64(10):863-8. doi: 10.1136/thx.2009.115725. Epub 2009 Jun 23.
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PubMed Identifier
14746730
Citation
Masa JF, Sobradillo V, Villasante C, Jimenez-Ruiz CA, Fernandez-Fau L, Viejo JL, Miravitlles M. [Costs of chronic obstructive pulmonary disease in Spain. Estimation from a population-based study]. Arch Bronconeumol. 2004 Feb;40(2):72-9. doi: 10.1016/s1579-2129(06)60198-5. Spanish.
Results Reference
background
Citation
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Results Reference
background
PubMed Identifier
18448019
Citation
Peces-Barba G, Barbera JA, Agusti A, Casanova C, Casas A, Izquierdo JL, Jardim J, Lopez Varela V, Monso E, Montemayor T, Viejo JL. [Diagnosis and management of chronic obstructive pulmonary disease: joint guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) and the Latin American Thoracic Society (ALAT)]. Arch Bronconeumol. 2008 May;44(5):271-81. No abstract available. Spanish.
Results Reference
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PubMed Identifier
18247154
Citation
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Citation
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Results Reference
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PubMed Identifier
12199927
Citation
Burgos F. [Inhalation therapy without instruction: failure foreseen]. Arch Bronconeumol. 2002 Jul;38(7):297-9. doi: 10.1016/s0300-2896(02)75221-6. No abstract available. Spanish.
Results Reference
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PubMed Identifier
14519287
Citation
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Citation
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Citation
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Citation
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Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/mesh?term=inhalators
Description
MeSH
URL
http://www.ncbi.nlm.nih.gov/mesh/68011320
Description
MeSH
URL
http://www.ncbi.nlm.nih.gov/mesh?term=education
Description
MeSH

Learn more about this trial

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

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