Back to resultsEducation With Inhalers in Patients With COPD Exacerbation
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ventilatory re-education
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:
- Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers.
Exclusion Criteria:
- Exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. Patients who had experienced an exacerbation of prior COPD in less than one month were excluded.
Sites / Locations
- Department of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
CONTROL GROUP
INTERVENTION GROUP
Arm Description
Received the standard medical and pharmacological care provided by the hospital
The group received the standard medical and pharmacological care provided by the hospital. In addition, an educational program on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program, furthermore, the technique of inhaler use was trained.
Outcomes
Primary Outcome Measures
Respiratory parameters
Changes 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 Outcome Measures
Knowledge of the disease
Evaluated at baseline by EPOC-Q
Cognitive Level
Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
Functional independence
Functional independence was assessed using the Functional Independence Scale (FIM).
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.
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.
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.
Respiratory parameters
Changes 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).
Full Information
NCT ID
NCT03337958
First Posted
September 20, 2017
Last Updated
July 11, 2018
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT03337958
Brief Title
Education With Inhalers in Patients With COPD Exacerbation
Official Title
Evaluation of an Educational Intervention in the Management of Inhalers With Tablet and Ventilatory Reeducation: a Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
July 2018 (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 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.
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
Model Description
A randomized clinical trial.
Masking
Participant
Allocation
Randomized
Enrollment
15 (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
INTERVENTION GROUP
Arm Type
Experimental
Arm Description
The group received the standard medical and pharmacological care provided by the hospital. In addition, an educational program on the use of inhalers, which included an explanation of the use of inhalers together with a ventilatory re-education program, furthermore, the technique of inhaler use was trained.
Intervention Type
Device
Intervention Name(s)
Ventilatory re-education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory parameters
Description
Changes 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)
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Knowledge of the disease
Description
Evaluated at baseline by EPOC-Q
Time Frame
Baseline, 12 months
Title
Cognitive Level
Description
Cognitive level was assessed using the Montreal Cognitive Assessment (MOCA).
Time Frame
Baseline
Title
Functional independence
Description
Functional independence was assessed using the Functional Independence Scale (FIM).
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.
Time Frame
Baseline
Title
Adhesion to inhalers
Description
Level of adhesion to inhalers was assessed with TAI (Inhaler Adhesion Test).
Time Frame
Baseline
Title
Dyspnea level
Description
Perceived perception of dyspnea was collected through the Modified Borg Scale.
Time Frame
baseline, 12 months
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
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
baseline, 12 months
Title
Respiratory parameters
Description
Changes 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).
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:
Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers.
Exclusion Criteria:
Exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. Patients who had experienced an exacerbation of prior COPD in less than one month were excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958 248035
Email
cvalenza@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PT, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Phone
958242360
Email
cvalenza@ugr.es
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Education With Inhalers in Patients With COPD Exacerbation
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