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Clinical Trials/NCT03337958
NCT03337958
Unknown
N/A

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

Universidad de Granada1 site in 1 country15 target enrollmentDecember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Universidad de Granada
Enrollment
15
Locations
1
Primary Endpoint
Respiratory parameters
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Principal investigator

Universidad de Granada

Eligibility Criteria

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)

Study Sites (1)

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