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Efficacy of an Education Protocol in the Correction of Inhalation Techniques in COPD

Primary Purpose

COPD, Education

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Education
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COPD focused on measuring Education, COPD, Inhalation Devices

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with COPD diagnosed by spirometry (presence of a postbronchodilator FEV1 / FVC ratio <0.7)
  • Over 40 years old
  • Use any of the following devices: metered dose inhaler, HandiHaler, Turbuhaler, Diskus, Aerolizer
  • Have at least one error in the inhalation technique
  • Signature of informed consent.

Exclusion Criteria:

  • Artificial airway
  • Cognitive impairment noted in the medical history
  • Hearing loss that complicates the compression of simple orders
  • Bilateral amaurosis
  • Functional dependence for the use of inhalers
  • Presence of abnormal movements in the upper limbs that interfere and / or impede the correct use of the devices

Sites / Locations

  • Hospital Italiano de Buenos Aires

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Education protocol to correct inhalation technique

Outcomes

Primary Outcome Measures

Changes in the inhalation technique
If the patient that presented errors or mistakes corrected inhalation technique

Secondary Outcome Measures

Type of error
Frequent errors in inhalation technique using different inhaler devices
Inhalation device
Inhaler that presents the greatest number of mistakes
Patient's characteristics
Characteristics of the patients who do not perform the inhalation technique correctly and those who, despite having completed the education protocol, continue to perform it incorrectly

Full Information

First Posted
May 2, 2017
Last Updated
May 4, 2017
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT03144557
Brief Title
Efficacy of an Education Protocol in the Correction of Inhalation Techniques in COPD
Official Title
Efficacy of an Education Protocol in the Correction of Inhalation Techniques in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the implementation of an education protocol and its impact on the correct inhalation technique in COPD patients presenting errors or mistakes. There will be 4 sessions, in each one the inhalation technique will be evaluated using a checklist of steps. Whenever errors are found, the correct use of each device will be educated through verbal explanation and written material will be delivered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Education
Keywords
Education, COPD, Inhalation Devices

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Education protocol to correct inhalation technique
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Education protocol included 4 individual sessions of verbal and graphic instructions to correct inhalation technique in patients with COPD
Primary Outcome Measure Information:
Title
Changes in the inhalation technique
Description
If the patient that presented errors or mistakes corrected inhalation technique
Time Frame
Baseline and every session (48-72 hours)
Secondary Outcome Measure Information:
Title
Type of error
Description
Frequent errors in inhalation technique using different inhaler devices
Time Frame
Baseline
Title
Inhalation device
Description
Inhaler that presents the greatest number of mistakes
Time Frame
Baseline
Title
Patient's characteristics
Description
Characteristics of the patients who do not perform the inhalation technique correctly and those who, despite having completed the education protocol, continue to perform it incorrectly
Time Frame
Baseline

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with COPD diagnosed by spirometry (presence of a postbronchodilator FEV1 / FVC ratio <0.7) Over 40 years old Use any of the following devices: metered dose inhaler, HandiHaler, Turbuhaler, Diskus, Aerolizer Have at least one error in the inhalation technique Signature of informed consent. Exclusion Criteria: Artificial airway Cognitive impairment noted in the medical history Hearing loss that complicates the compression of simple orders Bilateral amaurosis Functional dependence for the use of inhalers Presence of abnormal movements in the upper limbs that interfere and / or impede the correct use of the devices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guadalupe Gracia, PT-RT
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Efficacy of an Education Protocol in the Correction of Inhalation Techniques in COPD

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