Tablet-assisted Training in Exacerbated COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03601403
• Other study ID #: DF0075UG
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: April 2019

Study information

• Verified date: December 2018
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: April 2019
• Est. primary completion date: June 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• inhaler technique
The first day of the intervention consisted primarily of 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.

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences. University of Granada.	Granada.	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in the first second (FEV1)	Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.	[Time Frame: baseline, 12 months]
Secondary	Knowledge of the Chronic Obstructive Pulmonary Disease	Evaluated at baseline by Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q). COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, & Wallace, 2010). The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills. A higher punctuation indicates better results.	[Time Frame: Baseline, 12 months]
Secondary	Cognitive Level	Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).	[Time Frame: Baseline]
Secondary	Functional independence	Functional independence was assessed using the Functional Independence Mease Scale (FIM). This scale has 18 items that are grouped into 2 dimensions, 13 motor items, and 5 cognitive items. The total score range between 18 points (total dependence) to 126 points (Independence completes).	[Time Frame: Baseline]
Secondary	Anxiety-depression level	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. It is composed of 14 items, 7 for anxiety and 7 for depression and higher values are related to higher depression and anxiety.	[Time Frame: Baseline, 12 months]
Secondary	Adhesion to inhalers	Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).	[Time Frame: Baseline]
Secondary	Dyspnea level	Perceived perception of dyspnea was collected through the Modified Borg Scale. Patients have to choose a number between 0 ( no dyspnea) to 10 (higher dyspnea).	[Time Frame: Baseline]
Secondary	Physical fitness	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	[Time Frame: baseline, 12 months]
Secondary	Technique of the inhaler	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.	[Time Frame: baseline, 12 months]
Secondary	Pressure expiratory force (PEF)	Changes from baseline to postintervention in PEF were assessed using a peak flow.	[Time Frame: baseline, 12 months]