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A Comparison of Classic and Virtual Inhaler Training Methods in COPD Patients

20 april 2022 bijgewerkt door: Ayse Baha

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.

Studie Overzicht

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

102

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Ankara, Kalkoen
        • Ankara City Hospital
      • Ankara, Kalkoen
        • Gazi University Faculty of Medicine
      • Ankara, Kalkoen
        • UFUK UNIVERSITY FACULTY OF MEDICINE
      • Antalya, Kalkoen
        • Muratpasa District Health Directorate
      • Balıkesir, Kalkoen
        • Balıkesir State Hospital
      • Kütahya, Kalkoen
        • Kütahya University of Health Sciences
      • Manisa, Kalkoen
        • Celal Bayar University Faculty of Medicine
      • Mersin-10, Kalkoen, 99138
        • Near East University Faculty of Medicine
      • İzmir, Kalkoen
        • Dokuz Eylul University, Faculty of Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: FIT (face-to-face inhaler training)

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.

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.

Experimenteel: VIT (virtual inhaler training)

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.

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The success of virtual education
Tijdsspanne: 2 weeks
The primary outcome is to investigate whether video-mediated virtual inhaler training is successful in patients with COPD.
2 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Studie stoel: Ayse Baha, Near East University Faculty of Medicine
  • Hoofdonderzoeker: Dilek Yapar, Antalya Muratpasa District Health Directorate
  • Hoofdonderzoeker: Aylin O Alpaydin, Dokuz Eylul University Faculty of Medicine
  • Hoofdonderzoeker: Aycan Yuksel, UFUK UNIVERSITY FACULTY OF MEDICINE
  • Hoofdonderzoeker: Ayshan Mammadova, Gazi University Faculty of Medicine
  • Hoofdonderzoeker: Ali Uzan, Near East University Faculty of Medicine
  • Hoofdonderzoeker: Deniz Kizilirmak, Celal Bayar University Faculty of Medicine
  • Hoofdonderzoeker: Esen S Gulensoy, UFUK UNIVERSITY FACULTY OF MEDICINE
  • Hoofdonderzoeker: İlknur Kaya, Kütahya Faculty of Health Science
  • Hoofdonderzoeker: Irem Serifoglu, Ankara City Hospital Bilkent
  • Hoofdonderzoeker: Ismail Zehir, Kütahya Faculty of Science
  • Hoofdonderzoeker: Merve Y Senel, Balıkesir State Hospital
  • Hoofdonderzoeker: Nalan Ogan, UFUK UNIVERSITY FACULTY OF MEDICINE
  • Hoofdonderzoeker: Nurdan Kokturk, Gazi University Faculty of Medicine
  • Hoofdonderzoeker: Secil Sari, Celal Bayar University Faculty of Medicine
  • Hoofdonderzoeker: Umran O Sertcelik, Ankara City Hospiatl
  • Hoofdonderzoeker: Zuleyha Galata, Gazi University Faculty of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2021

Primaire voltooiing (Werkelijk)

31 december 2021

Studie voltooiing (Werkelijk)

31 december 2021

Studieregistratiedata

Eerst ingediend

13 april 2022

Eerst ingediend dat voldeed aan de QC-criteria

13 april 2022

Eerst geplaatst (Werkelijk)

19 april 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 april 2022

Laatste update ingediend die voldeed aan QC-criteria

20 april 2022

Laatst geverifieerd

1 april 2022

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • YDU/2021/89-1302

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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