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Clinical Trials/NCT05335265
NCT05335265CompletedNot Applicable

Is Virtual Inhaler Training Successful in COPD?

Ayse Baha10 sites in 1 country102 target enrollmentStarted: October 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
102
Locations
10
Primary Endpoint
The success of virtual education

Study Overview

Brief Summary

According to the World Health Organization data, the third most common cause of death in the world, is COPD , a disease that progresses with exacerbations (1). Exacerbations are the most important cause of morbidity and mortality in COPD (2). It is thought that most exacerbations occur (3,4) because highly effective inhaler treatments are unavailable to prevent and treat respiratory symptoms (5,6). However, using inhaler devices correctly can be difficult (jama7,8). Guidelines recommend evaluating and teaching inhaler use technique (5,6). Unfortunately, these are often not implemented, especially in a hospital setting (9,10). Worldwide, 25 billion dollars are spent annually on inhaler drugs, 5-7 billion dollars of which is estimated to be wasted because of incorrect technique. Beyond this financial cost, incorrect inhaler technique is associated with worse symptom control, lower quality of life and increased acute care costs, (11,12,13). Although these shortcomings are known, appropriate educational interventions are unfortunately not been available.

Additionally , patient's access to health services (especially face-to-face communication with recommended health providers) has been largely prevented due to the restrictions/requirements implemented against the pandemic in 2020,such as social isolation, staying away from public environments, and ensuring good personal and social hygiene.

Considering that inhaler training is done face-to-face by doctors or allied health personnel today, many patients did not receive inhaler drug use training. One of the most realistic solutions that we encountered with this pandemic is telemedicine. The use of internet-mediated training, which is a part of telemedicine, has come to the foreground. In a recently published study on chronic airway diseases (asthma and COPD), it was revealed that video-mediated inhaler training is as successful as classical face-to-face training (14).Our aim is to investigate whether video-mediated virtual inhaler training is successful in patients with COPD.

Detailed Description

Our aim is to investigate whether video-mediated virtual inhaler training is successful in patients with COPD

METHOD OF WORKING

Patients hospitalized due to COPD exacerbation and are ready to be discharged from the hospital will be included in this multicenter, prospective, randomized controlled study. Patients will be randomized according to a simple random numbers table, half of the patients will receive video-mediated virtual inhaler training (which is published on the Turkish Thoracic Society's official site and with permission for use obtained) and the other half will receive the same method as classical facial inhaler training videos.

Depending on the medical condition of the patients admitted to the ward, training will be implemented from the 24th hour of their hospitalization until their discharge stage, starting with 3 training sessions for 3 consecutive days. Upon hospital discharge, the technique of inhaler use evaluation will be carried out according to the "Application Steps of Inhalation Techniques Evaluation Form checklist" prepared using the Turkish Thoracic Society Patient's Booklet.

In inhaler technique training observation, inhaler technique control of the patient will be performed simultaneously by 2 observers independently (each observer will have a checklist) to demonstrate inter-observer consistency.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Masking Description

"Envelope" method was used in randomization.

-Each clinic prepared 12 envelopes, 6 of them have a paper with the words VIRTUAL EDUCATION and 6 of them CLASSIC EDUCATION. The patient was asked to draw one of these mixed envelopes. The form of education in the envelope was applied to the patient.

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who have not used MDI for at least 1 year.
  • Having COPD diagnosed with PFT (FEV1/FVC <70 in PFT in the last 1 year)
  • Being hospitalized with a COPD exacerbation and being discharged
  • Not having a hearing loss, mental disability, visual impairment and a physical impairment that would prevent the use of MDI
  • To have the necessary technological equipment to establish video communication on the phone
  • Who have agreed to participate in the study.

Exclusion Criteria

  • Patients who have used MDI or have training MDI for at least 1 year.
  • Having a hearing loss, mental disability, visual impairment and a physical impairment that would prevent the use of MDI
  • Have not the necessary technological equipment to establish video communication on the phone

Outcomes

Primary Outcomes

The success of virtual education

Time Frame: 2 weeks

The primary outcome is to investigate whether video-mediated virtual inhaler training is successful in patients with COPD.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ayse Baha
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ayse Baha

Associate Professor, MD

Near East University, Turkey

Study Sites (10)

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