- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05640739
The Effect of Demonstration and Video Viewing Education on Metered Dose Inhaler Usage Skills in Asthma Patients
December 6, 2022 updated by: Yasemin SAZAK, Hasan Kalyoncu University
The Effect of Demonstration and Video Viewing Education on Metered Dose Inhaler Usage Skills in Asthma Patients: A Randomized Controlled Study
In the treatment of respiratory diseases such as COPD and asthma, bronchodilators and steroids, which are essential drugs, are preferred to be administered by inhalation compared to oral and parenteral routes.
In the studies conducted with the use of inhaler drugs, it is seen that many wrong practices have been made regarding the techniques of using the inhaler drugs and that the correct usage techniques are not followed.
Inability to use the inhaler device fully and correctly; It causes consequences such as failure to control the disease, increase in drug use and side effects, increase in exacerbations, high hospitalization and waste of drugs, both undermining the trust in treatment and putting an extra burden on the health expenditures of the countries.
This research aim is to evaluate the effectiveness of the training given with the demonstration method and video watching method for the use of the Metered Dose Inhaler (MDI) in asthmatic patients, and to ensure that the patients learn the correct inhaler use techniques.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
The research was planned as a randomized controlled experimental study.
Patients who applied to the Elbistan State Hospital chest polyclinic with a diagnosis of asthma and met the criteria for inclusion in the study will be divided into control group, demonstration training group and video surveillance training groups.
Simple randomization method will be used to determine the groups.
The sample of the research; With G-Power, it was determined as 21 people for each group at 80% power, 5% error and 95% confidence interval.
To prevent data loss; It was decided to have 32 people in the control group, 32 people in the demonstration training group, and 32 people in the video watching training group.
After informing the patients about the study, the consent of the patients who agreed to participate in the study will be obtained and the research data will be collected by face-to-face interview method.
After the patient identification form is completed, the patients will be asked to use the MDI inhaler and the MDI use skills chart will be filled.
For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines.
The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application.
Data will be collected from the patients in the control group without any application and their ability to use MDI will be evaluated.
Patients in the demonstration group will be given inhaler training (practically) by the researcher.
The training will include steps compatible with the video.
The training will be completed by watching the MDI usage video prepared by the researchers in the patients in the video group.
After the training, the patients will be asked to use the inhaler again, and their skill scores will be re-evaluated, and the mistakes made by the patients will be shown by the researcher in the demonstration group, and in the video group by allowing them to watch the video again.
The patients in the control group will fill out the MDI skill form again (after 30 minutes) without any procedure.
To prevent drug overdose, patients will be administered with placebo training drugs.
The patients in the whole group will be called by the researcher on the 7th day of the study, and the patients will be asked to use their MDI drugs again, and the MDI use skill chart will be filled again.
The control group will then be given inhaler training by the researchers.
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gaziantep, Turkey, 27000
- Hasan Kalyoncu University
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Contact:
- Yasemin SAZAK, PhD student
- Phone Number: 5414474944
- Email: yaseminsazak44@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a confirmed asthma diagnosis
- be 18 years or older,
- Using MDI,
- Volunteer to participate in the research.
- Patients who do not have communication problems,
- Patients who can make video calls,
Exclusion Criteria:
- Not complying with the principle of volunteering
- Answering data collection forms incompletely
- Patients who did not answer calls for the last test and could not be reached
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group patients
Data will be collected from the patients in the control group without any application and their ability to use MDI will be evaluated.
|
|
Experimental: Demonstration group patients
Patients in the demonstration group will be given inhaler training (practically) by the researcher.
The training will include steps compatible with the video.
After the training, the patients will be asked to use inhaler drugs again, and their skill scores will be re-evaluated and the mistakes made by the patients will be shown by the researcher in the demonstration group.
On the 7th day of the study, the patients will be called by the researcher with a video call, and the patients will be asked to use their MDI drugs again, and the MDI use skill chart will be filled again.
|
The effectiveness of the training given by the demonstration method for the use of the Metered Dose Inhaler (MDI)
|
Experimental: Video group patients
The patients in the video group will be shown the video of using MDI prepared by the researchers.
The training will be completed by watching the MDI usage video prepared by the researchers in the patients in the video group.
After the training, the patients will be asked to use the inhaler again and their skill scores will be re-evaluated.
Their mistakes will be shown by making them watch it again from the video.
On the 7th day of the study, the patients will be called by the researcher with a video call, and the patients will be asked to use their MDI drugs again, and the MDI use skill chart will be filled again.
|
The effectiveness of the training given by video watching method for the use of the Metered Dose Inhaler (MDI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MDI Use Skills Chart
Time Frame: Baseline (Before training)
|
For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines.
The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application.
|
Baseline (Before training)
|
MDI Use Skills Chart
Time Frame: Immediately after training
|
For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines.
The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application.
|
Immediately after training
|
MDI Use Skills Chart
Time Frame: 7th day after training
|
For the steps of MDI use, it will be evaluated with the use of MDI skill chart based on the Thoracic Society National Asthma Diagnosis and Treatment Guidelines.
The total skill scores will be determined by giving 1 point for the correct application and 0 points for the incorrect application.
|
7th day after training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nermin OLGUN, Professor, Hasan Kalyoncu University Faculty of Nursing
- Principal Investigator: Keriman AYTEKIN KANADLI, Mustafa Kemal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 12, 2022
Primary Completion (Anticipated)
March 12, 2023
Study Completion (Anticipated)
May 12, 2023
Study Registration Dates
First Submitted
November 27, 2022
First Submitted That Met QC Criteria
December 6, 2022
First Posted (Estimate)
December 7, 2022
Study Record Updates
Last Update Posted (Estimate)
December 7, 2022
Last Update Submitted That Met QC Criteria
December 6, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HasanKU-SAZAK-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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