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

July 7, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Gaziantep, Turkey, 27000
        • Hasan Kalyoncu University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Demonstration method for the use of the Metered Dose Inhaler
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.
Behavioral: Video watching method for the use of the Metered Dose Inhaler
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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