Education With Inhalers in Patients With COPD Exacerbation
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Ventilatory re-education
- Registration Number
- NCT03337958
- Lead Sponsor
- Universidad de Granada
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INTERVENTION GROUP Ventilatory re-education 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.
- Primary Outcome Measures
Name Time Method Respiratory parameters baseline, 12 months 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)
- Secondary Outcome Measures
Name Time Method Dyspnea level baseline, 12 months Perceived perception of dyspnea was collected through the Modified Borg Scale.
Knowledge of the disease Baseline, 12 months Evaluated at baseline by EPOC-Q
Cognitive Level Baseline Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
Functional independence Baseline Functional independence was assessed using the Functional Independence Scale (FIM).
Anxiety-depression level Baseline 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.
Adhesion to inhalers Baseline Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
Physical fitness baseline, 12 months 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.
Technique of the inhaler baseline, 12 months 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.
Respiratory parameters baseline, 12 months 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).
Trial Locations
- Locations (1)
Department of Physical Therapy
🇪🇸Granada, Spain