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Clinical Trials/NCT03601403
NCT03601403
Unknown
Not Applicable

Tablet-assisted Training as a Complement Hospital Intervention in Patients With Acute Exacerbations of COPD

Universidad de Granada1 site in 1 country42 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Universidad de Granada
Enrollment
42
Locations
1
Primary Endpoint
Forced expiratory volume in the first second (FEV1)
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 a tablet-assisted training 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
April 2019
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

  • Diagnosed of exacerbation of COPD.
  • To possess pharmacological treatment in the form of inhalers.

Exclusion Criteria

  • Inability to provide informed consent.
  • Presence of psychiatric or cognitive disorders.
  • Organ failure or cancer.
  • Inability to cooperate.
  • Patients who had experienced an exacerbation in the last month.

Outcomes

Primary Outcomes

Forced expiratory volume in the first second (FEV1)

Time Frame: [Time Frame: baseline, 12 months]

Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.

Secondary Outcomes

  • Cognitive Level([Time Frame: Baseline])
  • Dyspnea level([Time Frame: Baseline])
  • Physical fitness([Time Frame: baseline, 12 months])
  • Knowledge of the Chronic Obstructive Pulmonary Disease([Time Frame: Baseline, 12 months])
  • Technique of the inhaler([Time Frame: baseline, 12 months])
  • Pressure expiratory force (PEF)([Time Frame: baseline, 12 months])
  • Functional independence([Time Frame: Baseline])
  • Adhesion to inhalers([Time Frame: Baseline])
  • Anxiety-depression level([Time Frame: Baseline, 12 months])

Study Sites (1)

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