Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05335265 |
| Other study ID # |
YDU/2021/89-1302 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Near East University, Turkey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
The patients will be called for a control appointment one week after hospital discharge, and
their inhaler technique will be recorded once more using the "inhaler technique control form"
by the same 2 observers independently.
RANDOMIZATION:
- ENVELOPE method will be used in randomization.
- Each clinic will prepare 12 envelopes, 6 of them will have a paper with the words
VIRTUAL EDUCATION and 6 of them CLASSIC EDUCATION. The patient will be asked to draw one
of these mixed envelopes. The form of education in the envelope will be applied to the
patient.
Protocol:
- Before discharge, the patient should receive a Metered-Dose Inhaler (MDI) training for 3
consecutive days.
- Classical education (face-to-face education):
- The person who will provide this training must be a health worker who is an expert
in their field.
- The health personnel who will provide the training should watch the Turkish
Thoracic Society MDI training video before giving the training and convey the steps
there to the patient (to ensure the patients receive training on an equal basis
with the patient who will receive video training).
- Training should be given 3 times on the first day, 2 times on the 2nd day, and once
on the 3rd day.
- During discharge, inhaler technical evaluation should be done according to the
"Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by
using the Patient's Booklet of the Turkish Thoracic Society.
- The people who will evaluate the patient's inhaler technique on the day of
discharge should be someone different from the health personnel who provided the
training.
- In inhaler technique observation, the patient's inhaler technique control should be
performed simultaneously by 2 observers independently (each observer will have a
checklist) to demonstrate inter-observer consistency.
Virtual training (video training):
- On the first day's training, the video should be watched 3 times a day, on the 2nd day
the video should be watched 2 times during the day, on the 3rd day (discharge) the video
should be watched once.
- In video training, the Turkish Thoracic Society Virtual Training Video, (a copy of the
video has been provided ), will be used.
- During discharge, inhaler technical evaluation should be done according to the
"Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by using
the Patient's Booklet of the Turkish Thoracic Society.
- The people who will evaluate the patient's inhaler technique on the day of discharge
should be someone different from the health personnel who provided the training.
- In inhaler technique observation, the patient's inhaler technique control should be
performed simultaneously by 2 observers independently (each observer will have a
checklist) to demonstrate inter-observer consistency.
- Upon hospital discharge, the patient should be prescribed a short-acting
bronchodilator MDI (This is already recommended for all patients in Groups A, B, C,
and D according to the GOLD guidelines. In this respect, our study does not fall
under a drug study).
- They should not be advised to watch or not watch the Inhaler Training Video at home
(If we allow them to access and watch the video at home, it will create bias). The
decision of whether to watch the video at home should be left to the patient (a
question will be asked about this at the control. It has been added to the form).
- The first control after discharge should be done in the 1st week. Patients who
cannot come to the hospital for a control appointment due to the pandemic will be
called by phone and inhaler techniques will be checked with video conversation.
(There is no legal issues as no image recording will be taken here).
