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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effectiveness of an Educational Intervention for Managing Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Patients in Primary Care: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380405
• Other study ID #: BRISA II. EPOC-Inhaladores
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: December 14, 2017
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2017
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Spain	Fundación para la Formación e Investigación Sanitarias de la Región de Murcia	Murcia	Region De Murcia

Sponsors (4)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	AstraZeneca, Consejeria de sanidad.Direccion general de planificacion, ordenacion sanitaria y farmaceutica e investigacion., MurciaSalud

Country where clinical trial is conducted

Spain, 

References & Publications (13)

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

Bourbeau J, Julien M, Maltais F, Rouleau M, Beaupré A, Bégin 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 Santé du Québec. 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. — View Citation

Burgos F. [Inhalation therapy without instruction: failure foreseen]. Arch Bronconeumol. 2002 Jul;38(7):297-9. Spanish. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2014;3:CD002990. — View Citation

Flor Escriche X, Rodríguez Mas M, Gallego Alvarez L, Alvarez Luque I, Juvanteny Gorgals J, Fraga Martínez MM, Sánchez Pinacho L. [Do our asthma patients still use inhalers incorrectly?]. Aten Primaria. 2003 Sep 30;32(5):269-74. Spanish. — View Citation

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. — View Citation

Instituto Nacional de Estadística INE. Encuesta Nacional de Salud 2006.

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. — View Citation

Masa JF, Sobradillo V, Villasante C, Jiménez-Ruiz CA, Fernández-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. Spanish. — View Citation

Miravitlles M, Soriano JB, García-Río F, Muñoz 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. — View Citation

Peces-Barba G, Barberà JA, Agustí A, Casanova C, Casas A, Izquierdo JL, Jardim J, López Varela V, Monsó 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. Spanish. — View Citation

Sobradillo V, Miravitlles M, Jiménez CA, Gabriel R, Viejo JL, Masa JF, Fernández-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. Spanish. — View Citation

Worth H. Self management in COPD: one step beyond? Patient Educ Couns. 1997 Dec;32(1 Suppl):S105-9. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 days, 30 days, 6 months
Secondary	Six minute walking test		15 days, 30 days, 6 months
Secondary	Medical Research Council Scale (MRC) to measure the level of dyspnea (Bestall y col).		15 days, 30 days, 6 months
Secondary	Number of recurrences		15 days, 30 days, 6 months
Secondary	Number of hospitalisations		15 days, 30 days, 6 months
Secondary	Visual assessment scales of the use of inhalers		15 days, 30 days, 6 months

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