Tablet-assisted Training in Exacerbated COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
inhaler technique
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Education, Dry Powder Inhalers, Metered Dose Inhalers, Pulmonary Disease, Chronic Obstructive
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.
Sites / Locations
- Faculty of Health Sciences. University of Granada.
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL GROUP
Inhaler technique
Arm Description
Received the standard medical and pharmacological care provided by the hospital
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.
Outcomes
Primary Outcome Measures
Forced expiratory volume in the first second (FEV1)
Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
Secondary Outcome Measures
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.
Cognitive Level
Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
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).
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.
Adhesion to inhalers
Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
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).
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
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.
Pressure expiratory force (PEF)
Changes from baseline to postintervention in PEF were assessed using a peak flow.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03601403
Brief Title
Tablet-assisted Training in Exacerbated COPD
Official Title
Tablet-assisted Training as a Complement Hospital Intervention in Patients With Acute Exacerbations of COPD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 23, 2018 (Actual)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Education, Dry Powder Inhalers, Metered Dose Inhalers, Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
Received the standard medical and pharmacological care provided by the hospital
Arm Title
Inhaler technique
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
inhaler technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Forced expiratory volume in the first second (FEV1)
Description
Changes from baseline to postintervention in FEV1vas evaluated by a spirometer.
Time Frame
[Time Frame: baseline, 12 months]
Secondary Outcome Measure Information:
Title
Knowledge of the Chronic Obstructive Pulmonary Disease
Description
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
[Time Frame: Baseline, 12 months]
Title
Cognitive Level
Description
Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
Time Frame
[Time Frame: Baseline]
Title
Functional independence
Description
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
[Time Frame: Baseline]
Title
Anxiety-depression level
Description
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
[Time Frame: Baseline, 12 months]
Title
Adhesion to inhalers
Description
Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
Time Frame
[Time Frame: Baseline]
Title
Dyspnea level
Description
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
[Time Frame: Baseline]
Title
Physical fitness
Description
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
[Time Frame: baseline, 12 months]
Title
Technique of the inhaler
Description
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
[Time Frame: baseline, 12 months]
Title
Pressure expiratory force (PEF)
Description
Changes from baseline to postintervention in PEF were assessed using a peak flow.
Time Frame
[Time Frame: baseline, 12 months]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Carmen Valenza, PH MD
Organizational Affiliation
Department of Physical Therapy. University of Granada.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada.
State/Province
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tablet-assisted Training in Exacerbated COPD
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