title: 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).
abstract: BACKGROUND
  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 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).
  
  
  METHODS
  This 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.
  
  
  CONCLUSIONS
  Our 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.
  
  
  BACKGROUND
  Current Controlled Trials ISRTCTN15106246.
authors.affiliation: Family and Community Medicine Teaching Unit of Malaga, Distrito Sanitario Málaga, Málaga, Spain.
authors.forename: Francisca
authors.initials: F
authors.lastname: Leiva-Fernández
authors.forename: José
authors.initials: J
authors.lastname: Leiva-Fernández
authors.forename: Fernando
authors.initials: F
authors.lastname: Zubeldia-Santoyo
authors.forename: Antonio
authors.initials: A
authors.lastname: García-Ruiz
authors.forename: Daniel
authors.initials: D
authors.lastname: Prados-Torres
authors.forename: Pilar
authors.initials: P
authors.lastname: Barnestein-Fonseca
mesh_terms: D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D004867:Equipment Design; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009330:Nebulizers and Vaporizers; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods*; D057240:Patient Preference; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy*; D012107:Research Design; D013030:Spain; D013647:Task Performance and Analysis; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents