Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01380405
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2011-05-31
2011-12-31
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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without health education
the normal practices without specific intervention
No interventions assigned to this group
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
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.
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.).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
40 Years
75 Years
ALL
Yes
Sponsors
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MurciaSalud
OTHER_GOV
Public Health Service, Murcia
OTHER
AstraZeneca
INDUSTRY
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
OTHER
Responsible Party
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Principal Investigators
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A Lopez-Santiago, MD
Role: PRINCIPAL_INVESTIGATOR
Consejeria de sanidad y consumo, Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion.
Locations
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Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Murcia, Murcia, Spain
Countries
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References
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Annesi- Maesano I. Epidemiology of chronic obstructive pulmonary disease. In: Siafakas NM, ed. Management of Chronic Obstructive Pulmonary Disease. 2006.
Sobradillo V, Miravitlles M, Jimenez CA, Gabriel R, Viejo JL, Masa JF, Fernandez-Fau L, Villasante C. [Epidemiological study of chronic obstructive pulmonary disease in Spain (IBERPOC): prevalence of chronic respiratory symptoms and airflow limitation]. Arch Bronconeumol. 1999 Apr;35(4):159-66. doi: 10.1016/s0300-2896(15)30272-6. Spanish.
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.
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.
Instituto Nacional de Estadística INE. Encuesta Nacional de Salud 2006.
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.
Haupt D, Krigsman K, Nilsson JL. Medication persistence among patients with asthma/COPD drugs. Pharm World Sci. 2008 Oct;30(5):509-14. doi: 10.1007/s11096-008-9197-4. Epub 2008 Feb 5.
Jung E, Pickard AS, Salmon JW, Bartle B, Lee TA. Medication adherence and persistence in the last year of life in COPD patients. Respir Med. 2009 Apr;103(4):525-34. doi: 10.1016/j.rmed.2008.11.004. Epub 2009 Jan 12.
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.
Flor Escriche X, Rodriguez Mas M, Gallego Alvarez L, Alvarez Luque I, Juvanteny Gorgals J, Fraga Martinez MM, Sanchez Pinacho L. [Do our asthma patients still use inhalers incorrectly?]. Aten Primaria. 2003 Sep 30;32(5):269-74. doi: 10.1016/s0212-6567(03)79273-7. Spanish.
Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupre A, Begin R, Renzi P, Nault D, Borycki E, Schwartzman K, Singh R, Collet JP; Chronic Obstructive Pulmonary Disease axis of the Respiratory Network Fonds de la Recherche en Sante du Quebec. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Arch Intern Med. 2003 Mar 10;163(5):585-91. doi: 10.1001/archinte.163.5.585.
Worth H. Self management in COPD: one step beyond? Patient Educ Couns. 1997 Dec;32(1 Suppl):S105-9. doi: 10.1016/s0738-3991(97)00102-x.
Effing T, Monninkhof EM, van der Valk PD, van der Palen J, van Herwaarden CL, Partidge MR, Walters EH, Zielhuis GA. Self-management education for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002990. doi: 10.1002/14651858.CD002990.pub2.
Related Links
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Other Identifiers
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BRISA II. EPOC-Inhaladores
Identifier Type: -
Identifier Source: org_study_id