Study protocol for a randomized, controlled trial comparing the efficacy of two educational interventions to improve inhalation techniques in patients with chronic obstructive pulmonary disease (COPD): TIEPOC Study.

Article Details

Authors
José Leiva-Fernández, Francisca Leiva-Fernández, Rubén L Vázquez-Alarcón, Antonio García-Ruiz, Daniel Prados-Torres, Pilar Barnestein-Fonseca

Article Type
Case Report

DOI
doi: 10.7573/dic.212261

Related Articles

Article Page

Abstract

Background: An appropriate inhalation technique and adherence to treatment are both critical determinants of the success of chronic obstructive pulmonary disease (COPD) management. We have observed that up to 75% of patients do not use a successful inhalation technique. Knowledge evaluation and frequent reassessment of inhaler use, together with education of patients and healthcare professionals, can significantly improve the benefits that patients with COPD will derive from inhaler therapy. The objective of this study is to test the efficacy of two educational interventions to improve inhalation techniques in patients with COPD.

Methods: Multicenter randomized controlled trial with 296 patients diagnosed with COPD selected by a non-probabilistic method of sampling from seven Spanish Primary Care Centers. The patients will be divided into three groups by block randomization. The three groups are: 1) control; 2) Intervention A; and 3) Intervention B. The control group will comprise patients with no explanations or written information; the Intervention A group will comprise patients to whom we give written information only; and the Intervention B group will comprise patients to whom we give written information plus instructor training. Every patient in each group will be visited four times during the year of the study at the health centers.

Discussion: Our hypothesis is that the application of educational interventions (A or B) in patients with COPD who use inhaler 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, where feasible within the context of clinical practice. post-index period.

Keywords: COPD; inhalation techniques; educational intervention; treatment adherence; self-management; patient empowerment

Citation: Leiva-Fernández J, Leiva-Fernández F, Vázquez-Alarcón RL, García-Ruiz A, Prados-Torres D, Barnestein-Fonseca P. Study protocol for a randomized, controlled trial comparing the efficacy of two educational interventions to improve inhalation techniques in patients with chronic obstructive pulmonary disease (COPD): TIEPOC Study. Drugs in Context 2014;3:212261. doi: 10.7573/dic.212261

Provenance: Submitted, externally peer reviewed

Dates: Submitted: 4 March 2014
; Accepted, subject to peer review: 4 March 2014
; Revised manuscript submitted: 8 April 2014
; Published: 24 April 2014

Copyright: © 2014 Leiva-Fernández J, Leiva-Fernández F, Vázquez-Alarcón RL, García-Ruiz A, Prados-Torres D, Barnestein-Fonseca P. This is an open-access article distributed under the terms of the Creative Commons Attribution License Deed CC BY 3.0 which allows anyone to copy, distribute, transmit and adapt the article provided it is properly attributed in the manner specified below.

Correct attribution: Copyright © 2014 Leiva-Fernández J, Leiva-Fernández F, Vázquez-Alarcón RL, García-Ruiz A, Prados-Torres D, Barnestein-Fonseca P. http://dx.doi.org/10.7573/dic.212261. Published by Drugs in Context under Creative Commons Attribution License Deed CC BY 3.0.

Correspondence: Pilar Barnestein-Fonseca: DSc, MHS. MHS Multiprofessional Family and Community Medicine Teaching Unit of Primary Care Trust Málaga, Málaga, Spain

Email: mariap.barnestein.exts@juntadeandalucia.es

Trial Registration Number: Current Controlled Trials ISRCTN60147249

Download free full text PDF