Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD). TECEPOC: study protocol for a partially randomized controlled trial (preference trial)

Daniel Prados-Torres,Francisca Leiva-Fernández,Pilar Barnestein-Fonseca,Antonio García-Ruiz,Fernando Zubeldia-Santoyo,José Leiva-Fernández

doi:10.1186/1745-6215-13-64

Daniel Prados-Torres, Francisca Leiva-Fernández + Show 4 more

Open Access

https://doi.org/10.1186/1745-6215-13-64

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Journal: Trials	Publication Date: May 21, 2012
Citations: 52	License type: cc-by

Affiliation: Universidad de Málaga

Abstract

BackgroundDrugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD).MethodsThis study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1) the patients´ preference group with two arms and 2) the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B) designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques). Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center.DiscussionOur hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice.Trial registrationCurrent Controlled Trials ISRTCTN15106246

Highlights

Drugs for inhalation are the cornerstone of therapy in obstructive lung disease
dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs) are the devices most commonly used for drug delivery in the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD) patients [1,2]
This study permitted us to analyze deeply the motives and barriers or difficulties that these patients have in complying with the recommended medication regimens

Summary

Introduction

Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD). Inhalers are the principle vehicles for the effective administration of medication. They allow high lung deposition of the drug and minimize systemic adverse drug reactions [1,2]. The effectiveness of drugs for inhalation can be influenced by many factors including age, sex, education of the patient, duration of disease, type of inhaler used, correct inhalation technique and use of several inhalers [2,3]. DPIs and pMDIs are the devices most commonly used for drug delivery in the treatment of asthma and COPD patients [1,2]

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