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Education With Inhalers in Patients With COPD Exacerbation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03337958
Enrollment
15
Registered
2017-11-09
Start date
2017-12-01
Completion date
2018-07-31
Last updated
2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Education, Dry Powder Inhalers, Metered Dose Inhalers, Pulmonary Disease, Chronic Obstructive

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.

Interventions

DEVICEVentilatory re-education

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.

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

A randomized clinical trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

*

Design outcomes

Primary

MeasureTime frameDescription
Respiratory parametersbaseline, 12 monthsChanges 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

MeasureTime frameDescription
Cognitive LevelBaselineCognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
Functional independenceBaselineFunctional independence was assessed using the Functional Independence Scale (FIM).
Anxiety-depression levelBaselineChanges 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 inhalersBaselineLevel of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
Knowledge of the diseaseBaseline, 12 monthsEvaluated at baseline by EPOC-Q
Physical fitnessbaseline, 12 monthsPhysical 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 inhalerbaseline, 12 monthsThe 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 parametersbaseline, 12 monthsChanges 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).
Dyspnea levelbaseline, 12 monthsPerceived perception of dyspnea was collected through the Modified Borg Scale.

Countries

Spain

Contacts

Primary ContactMarie Carmen Valenza, PhD
cvalenza@ugr.es958 248035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026