Tablet-assisted Training in Exacerbated COPD

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: inhaler technique

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 Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada
    • Granada., Granada, Spain, 18071
      • Faculty of Health Sciences. University of Granada.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL GROUP; Received the standard medical and pharmacological care provided by the hospital
Experimental: Inhaler technique; The intervention group received the standard medical and pharmacological care provided by the hospital. In addition, a tablet-assisted training on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]
Cognitive Level	Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).	[Time Frame: Baseline]
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]
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]
Adhesion to inhalers	Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).	[Time Frame: Baseline]
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]
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]
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]
Pressure expiratory force (PEF)	Changes from baseline to postintervention in PEF were assessed using a peak flow.	[Time Frame: baseline, 12 months]

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: M. Carmen Valenza, PH MD, Department of Physical Therapy. University of Granada.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 23, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Education; Metered Dose Inhalers; Pulmonary Disease; Chronic Obstructive; Dry Powder Inhalers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: DF0075UG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No