NCT07134647

Brief Summary

Asthma is a chronic airway inflammation characterized by recurrent attacks, airway hyperresponsiveness, mucus hypersecretion, and airway obstruction. It ranks 16th among the most serious diseases in terms of duration and severity of disability. The disease poses a significant social and economic burden and morbidity for families and the healthcare system. It is estimated that approximately 300 million people worldwide are affected by asthma, and this number is expected to reach 400 million by 2025. Symptoms, airflow limitation, and its degree vary significantly over time in asthma. These changes are generally influenced by various stimuli, such as the presence of allergies or irritants, physical activity, air changes, or respiratory infections. Therefore, proper management of asthma, which poses a significant problem for both patients and society, is crucial. The goals of asthma treatment are to provide symptom control, reduce exacerbations, and alleviate fixed airway obstruction and medication side effects. Oral, parenteral, and inhaled agents are currently used in treatment. Inhaled treatments offer advantages over other treatment methods because they deliver medications directly to the airways and accumulate there, resulting in a faster onset of action and fewer side effects due to the use of smaller doses. Because inhaled medication must reach the targeted airways for it to be effective, proper inhalation technique is as important as adherence to treatment. However, it is known that 70-80% of patients fail to use their inhalers correctly. Failure to use inhalers properly and correctly leads to ineffective treatment, uncontrolled disease, frequent attacks, increased medication use, hospitalizations, and increased costs. Therefore, the most fundamental element of asthma treatment is inhaler use training. In addition to providing information about the disease, the patient should be thoroughly and practically instructed on how and when to use asthma medications. However, studies conducted in our country have shown that the rate of inhaler use using the correct technique is quite low. However, asthma management education has been proven effective in improving asthma control and quality of life. Numerous studies confirm that the use of smartphone-based apps is a promising educational tool. Effective use of new mobile apps and smart technologies is also noted to be important in improving treatment adherence rates, improving inhaler technique, and improving asthma control. Therefore, this study aimed to evaluate the effects of video-animated inhaler medication education on medication adherence, seizure frequency, and dyspnea in asthmatic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 15, 2025

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Video animation-assisted inhaler drug education has effects on drug compliance, attack frequency and dyspnea.

    Data were collected using a questionnaire, the mMRC Shortness of Breath Scale, the Asthma Control Test (ACT), and the Inhaler Compliance Scale. The mMRC Shortness of Breath Scale is a 5-point scale (0-4). A higher score indicates greater severity of dyspnea. The Asthma Control Test (ACT) is a 25-point scale. A higher score is considered good control. The Inhaler Compliance Scale is a 30-point scale. A higher score indicates good inhaler compliance. The mMRC Shortness of Breath Scale, the Asthma Control Test (ACT), and the Inhaler Compliance Scale were administered to both groups at the beginning of the study and at the end of the fourth week. After 3 sessions of training, the decrease in the mMRC Shortness of Breath Scale mean score and the increase in the Asthma Control Test (ACT) and Inhaler Compliance Scale mean score indicate that the training was effective. Student t, chi-square, Mann Whitney U and Kruskal Wallis tests were used to evaluate the data.

    Each patient will be followed up for 30 days.

Study Arms (2)

Control group

NO INTERVENTION

The control group will not receive training. The evaluation form will be administered simultaneously with the intervention group. At the end of the study, the patient will be shown the video once if they wish.

INTERVENTION GROUP

EXPERIMENTAL

Patients in the intervention group will watch an educational video at the beginning of the study, on the 15th day, and at the 4th week.

Behavioral: video animation-supported inhaler medication training

Interventions

The training is presented not verbally but with the prepared "Video Animation Support"

INTERVENTION GROUP

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are:
  • years of age or older,
  • Diagnosed with asthma for at least 6 months,
  • Using at least one inhaler,
  • No communication problems that would prevent them from participating in the study or receiving training,
  • Literate,
  • Have internet access at home or on their phone,
  • Own and use a computer, tablet, or smartphone,
  • Voluntarily agree to participate in the study

You may not qualify if:

  • Individuals who:
  • Are unwilling to participate in the study,
  • Do not own a computer, tablet, or smartphone,
  • Have a psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep Üniversitesi

Gaziantep, 27000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Before the training, the researcher will administer data collection forms to both groups using a face-to-face interview. The researcher will then provide a face-to-face "Video Animation-Assisted Inhaler Medication Education" to the patients in the intervention group. After the initial interview, all training sessions will be provided online via the training link, and patients will be contacted weekly to request a repeat session. Patients will receive weekly online reminders of the training sessions. Patients in the control group will not receive any interventions other than the clinic's routine procedures. Data collection tools will be administered simultaneously with the intervention group. The control group will receive video-assisted inhaler medication education at the end of the study, if they wish. The questionnaire and scales will be administered at the beginning of the study, on day 15, and at the end of week 4.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 15, 2025

First Posted

August 21, 2025

Study Start

February 1, 2025

Primary Completion

June 15, 2025

Study Completion

July 15, 2025

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations