Evaluation of an Educational Intervention in the Management of Inhalers With Tablet and Ventilatory Reeducation: a Randomized Clinical Study
Overview
- Phase
- Not Applicable
- Sponsor
- Universidad de Granada
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Respiratory parameters
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Respiratory parameters
Time Frame: 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 Outcomes
- Dyspnea level(baseline, 12 months)
- Knowledge of the disease(Baseline, 12 months)
- Cognitive Level(Baseline)
- Functional independence(Baseline)
- Anxiety-depression level(Baseline)
- Adhesion to inhalers(Baseline)
- Physical fitness(baseline, 12 months)
- Technique of the inhaler(baseline, 12 months)
- Respiratory parameters(baseline, 12 months)
Investigators
Marie Carmen Valenza
Principal investigator
Universidad de Granada