Education With Inhalers in Patients With COPD Exacerbation

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of an educational intervention in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.

Detailed Description
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The importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. In Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. The clinical development of COPD includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. During these hospitalizations, respiratory symptoms are worsening.Nevertheless, in Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. Thus, it is very important the pharmacological education in this patients.

Official Title
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Evaluation of an Educational Intervention in the Management of Inhalers With Tablet and Ventilatory Reeducation: a Randomized Clinical Study

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Ventilatory re-education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers. Exclusion Criteria: Exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. Patients who had experienced an exacerbation of prior COPD in less than one month were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL GROUP<br>Received the standard medical and pharmacological care provided by the hospital | |
| Experimental: INTERVENTION GROUP<br>The group received the standard medical and pharmacological care provided by the hospital. In addition, an educational program on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program, furthermore, the technique of inhaler use was trained. | Device: Ventilatory re-education<br>* The first day of intervention consisted primarily in ventilatory re-education. During the realization of the technique he was videotaped with a Tablet so that later the patient could be seen and on the video to be able to give him the guidelines for the correction. On the second and third day of the intervention, ventilation re-education was performed and the inhalation technique was subsequently trained.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory parameters | Changes from baseline to postintervention in respiratory parameters using a spirometer. The most important respiratory parameters evaluated is forced expiratory volume in the first second (FEV1) | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of the disease | Evaluated at baseline by EPOC-Q | Baseline, 12 months | 
| Cognitive Level | Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA). | Baseline | 
| Functional independence | Functional independence was assessed using the Functional Independence Scale (FIM). | Baseline | 
| Anxiety-depression level | Changes from baseline to postintervention in anxiety and depression measured with the Hospital Anxiety and Depression Scale. Patients are going to complete this questionnaire composed of statements relevant to either generalized anxiety or depression. | Baseline | 
| Adhesion to inhalers | Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test). | Baseline | 
| Dyspnea level | Perceived perception of dyspnea was collected through the Modified Borg Scale. | baseline, 12 months | 
| Physical fitness | Physical fitness was assessed by performing the five-times-sit-to-stand test. It consists of getting up and sitting five times in a row without a support. The time period in which the exercise is performed is the patient's score with a maximum of 60 seconds. | baseline, 12 months | 
| Technique of the inhaler | The evaluation of the technique of the inhalers was carried out by means of a checklist composed of 5 items. Checked those points that were done correctly obtaining 5 points if the technique that was done correctly. | baseline, 12 months | 
| Respiratory parameters | Changes from baseline to postintervention in respiratory parameters using a spirometer as recommended by the American Thoracic Society. The most important respiratory parameters evaluated are forced vital capacity (FVC), carbon dioxide partial pressure (PCO2) and oxygen partial pressure (PO2). | baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Dry Powder Inhalers, Metered Dose Inhalers, Pulmonary Disease, Chronic Obstructive