Tablet-assisted Training in Exacerbated COPD

NCT03601403 | Unknown

• 1 other identifier: DF0075UG
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Knowledge of the Chronic Obstructive Pulmonary Disease

  [Time Frame: Baseline, 12 months]

• Cognitive Level

  [Time Frame: Baseline]

• Functional independence

  [Time Frame: Baseline]

• Anxiety-depression level

  [Time Frame: Baseline, 12 months]

• Adhesion to inhalers

  [Time Frame: Baseline]

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

Received the standard medical and pharmacological care provided by the hospital

Inhaler technique

EXPERIMENTAL

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

Interventions

inhaler technique DEVICE

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.

Inhaler technique

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• M. Carmen Valenza, PH MD

  Department of Physical Therapy. University of Granada.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 26, 2018
• Study Start: December 1, 2017
• Primary Completion: June 23, 2018
• Study Completion: April 1, 2019
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

ES (1)