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The Effect of Demonstration and Video Viewing Education on Metered Dose Inhaler Usage Skills in Asthma Patients

Primary Purpose

Asthma, Patient Education

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Demonstration method for the use of the Metered Dose Inhaler
Video watching method for the use of the Metered Dose Inhaler
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Metered Dose Inhalers, Patient Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group patients

Demonstration group patients

Video group patients

Arm Description

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. 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 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.

Outcomes

Primary Outcome Measures

MDI Use Skills Chart
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.
MDI Use Skills Chart
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.
MDI Use Skills Chart
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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2022
Last Updated
December 6, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05640739
Brief Title
The Effect of Demonstration and Video Viewing Education on Metered Dose Inhaler Usage Skills in Asthma Patients
Official Title
The Effect of Demonstration and Video Viewing Education on Metered Dose Inhaler Usage Skills in Asthma Patients: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 12, 2022 (Anticipated)
Primary Completion Date
March 12, 2023 (Anticipated)
Study Completion Date
May 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Patient Education
Keywords
Metered Dose Inhalers, Patient Education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group patients
Arm Type
No Intervention
Arm Description
Data will be collected from the patients in the control group without any application and their ability to use MDI will be evaluated.
Arm Title
Demonstration group patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Video group patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Demonstration method for the use of the Metered Dose Inhaler
Intervention Description
The effectiveness of the training given by the demonstration method for the use of the Metered Dose Inhaler (MDI)
Intervention Type
Behavioral
Intervention Name(s)
Video watching method for the use of the Metered Dose Inhaler
Intervention Description
The effectiveness of the training given by video watching method for the use of the Metered Dose Inhaler (MDI)
Primary Outcome Measure Information:
Title
MDI Use Skills Chart
Description
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.
Time Frame
Baseline (Before training)
Title
MDI Use Skills Chart
Description
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.
Time Frame
Immediately after training
Title
MDI Use Skills Chart
Description
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.
Time Frame
7th day after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasemin SAZAK
Phone
5414474944
Email
yaseminsazak44@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nermin OLGUN, Professor
Organizational Affiliation
Hasan Kalyoncu University Faculty of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keriman AYTEKIN KANADLI
Organizational Affiliation
Mustafa Kemal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasemin SAZAK, PhD student
Phone
5414474944
Email
yaseminsazak44@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Demonstration and Video Viewing Education on Metered Dose Inhaler Usage Skills in Asthma Patients

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