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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144557
• Other study ID #: 3064
• Status: Completed
• Phase: N/A
• First received: May 2, 2017
• Last updated: May 4, 2017
• Start date: January 2, 2017
• Est. completion date: April 30, 2017

Study information

• Verified date: May 2017
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Education
• Respiratory Aspiration

Intervention

Other:
• Education
Education protocol included 4 individual sessions of verbal and graphic instructions to correct inhalation technique in patients with COPD

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the inhalation technique	If the patient that presented errors or mistakes corrected inhalation technique	Baseline and every session (48-72 hours)
Secondary	Type of error	Frequent errors in inhalation technique using different inhaler devices	Baseline
Secondary	Inhalation device	Inhaler that presents the greatest number of mistakes	Baseline
Secondary	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	Baseline