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

May 4, 2017 updated by: Hospital Italiano de Buenos Aires

Efficacy of an Education Protocol in the Correction of Inhalation Techniques in Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Education protocol to correct inhalation technique
Other: Education
Education protocol included 4 individual sessions of verbal and graphic instructions to correct inhalation technique in patients with COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the inhalation technique
Time Frame: Baseline and every session (48-72 hours)
If the patient that presented errors or mistakes corrected inhalation technique
Baseline and every session (48-72 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of error
Time Frame: Baseline
Frequent errors in inhalation technique using different inhaler devices
Baseline
Inhalation device
Time Frame: Baseline
Inhaler that presents the greatest number of mistakes
Baseline
Patient's characteristics
Time Frame: Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: Guadalupe Gracia, PT-RT, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2017

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3064

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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