COPDNCT05335265
A Comparison of Classic and Virtual Inhaler Training Methods in COPD Patients
A study testing Treatment training in people with COPD and Inhaler Training, run by Ayse Baha at 9 sites in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- COPD, Inhaler Training, Face-to-face Training
- What is being tested?
- Treatment training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 9 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Turkey (Türkiye)9 sites
Ankara City Hospital
Ankara
Gazi University Faculty of Medicine
Ankara
Ufuk University Faculty of Medicine
Ankara
Muratpasa District Health Directorate
Antalya
Balıkesir State Hospital
Balıkesir
Dokuz Eylul University, Faculty of Medicine
Izmir
Kütahya University of Health Sciences
Kütahya
Celal Bayar University Faculty of Medicine
Manisa
Near East University Faculty of Medicine
Mersin-10, 99138
About this study
Official title: Is Virtual Inhaler Training Successful in COPD?
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.
Read the 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.
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).
- Being tested
- Treatment training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment trainingOther
Face-to-face:Metered-DoseInhalerTraining gave 3 times on the 1st day, 2 times on the 2nd day, once on the 3rd day.During discharge, inhaler technical evaluation were done according to the "Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by using the Patient's Booklet of the Turkish Thoracic Society (TTS).The people who is evaluate the patient's inhaler technique (IT) on the day of discharge was someone different from the health personnel who provided the training. In IT control, the patient's performance was evaluated simultaneously by 2 observers.
Video training:Training gave 3 times on the 1st day, 2 times on the 2nd day,once on the 3rd day.The TTS-Virtual Training Video were used.During discharge,inhaler technical evaluation was done same with face-to-face training.The person who is evaluate the patient's IT was someone different from the training personnel.In IT observation,it was used same method with face-to-face training.
| Study group | Role | What they receive |
|---|---|---|
| FIT (face-to-face inhaler training) | Active comparator | Face-to-face inhaler training.
o The trainers watched the Turkish Thoracic Society (TTS) MDI training video before giving the training.
Training given 3 times on the first day, 2 times on the 2nd day, and once on the 3rd day.
During discharge, inhaler technic was checked according to the "Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by TTS.
The trainer and the inhaler technical controller are different. Receives: Other: Treatment training |
| VIT (virtual inhaler training) | Experimental | Virtual Training was gave 3 times on the first day, 2 times on the 2nd day, and once on the 3rd day (discharge) by the TTS Virtual training video.
During discharge, inhaler technics of the patient's were controlled according to the "Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by the TTS.
o The inhaler technique controller and the trainer are different. Receives: Other: Treatment training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of virtual education
The primary outcome is to investigate whether video-mediated virtual inhaler training is successful in patients with COPD.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized according to a simple random numbers table, half of the patients received 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 received classical face-to-face inhaler training. "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.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayse Baha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayse Baha, Near East University, Turkey
- Investigators
- Ayse Baha, Study chair, Near East University Faculty of MedicineDilek Yapar, Principal investigator, Antalya Muratpasa District Health DirectorateAylin O Alpaydin, Principal investigator, Dokuz Eylül University Faculty of MedicineAycan Yuksel, Principal investigator, Ufuk UniversityAyshan Mammadova, Principal investigator, Gazi University Faculty of MedicineAli Uzan, Principal investigator, Near East University Faculty of MedicineDeniz Kizilirmak, Principal investigator, Celal Bayar University Faculty of MedicineEsen S Gulensoy, Principal investigator, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335265
- Sponsor's protocol ID
- YDU/2021/89-1302
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Virtual Inhaler Training Successful in COPD?
- ClinicalTrials.gov ID
- NCT05335265
- Acronym / sponsor ID
- YDU/2021/89-1302
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ayse BahaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients randomized according to a simple random numbers table, half of the patients received 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 received classical face-to-face inhaler training. "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.
| Arm | Type | Receives |
|---|---|---|
| FIT (face-to-face inhaler training) | Active comparator | Other: Treatment trainingFace-to-face inhaler training. o The trainers watched the Turkish Thoracic Society (TTS) MDI training video before giving the training. Training given 3 times on the first day, 2 times on the 2nd day, and once on the 3rd day. During discharge, inhaler technic was checked according to the "Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by TTS. The trainer and the inhaler technical controller are different. |
| VIT (virtual inhaler training) | Experimental | Other: Treatment trainingVirtual Training was gave 3 times on the first day, 2 times on the 2nd day, and once on the 3rd day (discharge) by the TTS Virtual training video. During discharge, inhaler technics of the patient's were controlled according to the "Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by the TTS. o The inhaler technique controller and the trainer are different. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment trainingFace-to-face:Metered-DoseInhalerTraining gave 3 times on the 1st day, 2 times on the 2nd day, once on the 3rd day.During discharge, inhaler technical evaluation were done according to the "Application Steps of Inhalation Techniques Evaluation Form checklist" prepared by using the Patient's Booklet of the Turkish Thoracic Society (TTS).The people who is evaluate the patient's inhaler technique (IT) on the day of discharge was someone different from the health personnel who provided the training. In IT control, the patient's performance was evaluated simultaneously by 2 observers. Video training:Training gave 3 times on the 1st day, 2 times on the 2nd day,once on the 3rd day.The TTS-Virtual Training Video were used.During discharge,inhaler technical evaluation was done same with face-to-face training.The person who is evaluate the patient's IT was someone different from the training personnel.In IT observation,it was used same method with face-to-face training. | Other | FIT (face-to-face inhaler training), VIT (virtual inhaler training) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Baha study chair
Near East University Faculty of Medicine
Dilek Yapar principal investigator
Antalya Muratpasa District Health Directorate
Aylin O Alpaydin principal investigator
Dokuz Eylül University Faculty of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment training in people with COPD and Inhaler Training, run by Ayse Baha at 9 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success of virtual education (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.