NCT05640739

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

November 27, 2022

Last Update Submit

July 7, 2024

Conditions

Keywords

Metered Dose InhalersPatient Education

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline (Before training)

  • 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.

    Immediately after training

  • 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.

    7th day after training

Study Arms (3)

Control group patients

NO INTERVENTION

Data will be collected from the patients in the control group without any application and their ability to use MDI will be evaluated.

Demonstration group patients

EXPERIMENTAL

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

Video group patients

EXPERIMENTAL

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

Interventions

The effectiveness of the training given by the demonstration method for the use of the Metered Dose Inhaler (MDI)

Demonstration group patients

The effectiveness of the training given by video watching method for the use of the Metered Dose Inhaler (MDI)

Video group patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Nermin OLGUN, Professor

    Hasan Kalyoncu University Faculty of Nursing

    PRINCIPAL INVESTIGATOR
  • Keriman AYTEKIN KANADLI

    Mustafa Kemal University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2022

First Posted

December 7, 2022

Study Start

December 12, 2022

Primary Completion

March 12, 2023

Study Completion

May 12, 2023

Last Updated

July 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations