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Набор скоро начнётся NCT06909318

Animated Video and Booklet Education for Improving Asthma Control and Medication Compliance in Children

Без фазы С лечением Asthma Bronchiale

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Asthma Education - Animated Video, Booklet Group.
Кому может быть актуально
Состояния в реестре: Asthma Bronchiale. Базовые параметры: 7 лет — 11 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of Animated Video and Booklet Education on Asthma Control and Medication Compliance in Children With Asthma: A Randomized Controlled Study

Обзор

Asthma is a chronic inflammatory disease that causes wheezing, coughing, and shortness of breath, and it is a significant cause of morbidity and mortality in the pediatric population. The World Health Organization (WHO) estimated that 262 million people were affected by asthma in 2019, with 461,000 asthma-related deaths annually. In Turkey, the prevalence of asthma in children aged 6-12 ranges from 2% to 16%. Inadequate asthma control in children is often associated with poor medication adherence, lack of knowledge, misbeliefs, and ineffective communication with healthcare professionals. Education is therefore a crucial element of successful asthma management. Recently, the use of digital tools such as animated videos has become increasingly popular in pediatric education due to their engaging and interactive nature. Studies have shown that visual and interactive materials can improve knowledge, satisfaction, and adherence in children with chronic illnesses. This randomized controlled study aims to evaluate the effect of an educational intervention using an animated video and booklet on asthma control and medication compliance in children aged 7-11 diagnosed with asthma. It is expected that this child-friendly, visually enriched educational approach will enhance asthma management and support medication adherence in children.

Подробное описание

Asthma is a chronic inflammatory airway disease that affects millions of children worldwide and significantly impacts their quality of life, school attendance, and overall health. Despite the availability of effective treatments, asthma control remains suboptimal in many pediatric patients, often due to poor adherence, misinformation, and inadequate education. Educational interventions tailored to children's developmental levels are essential for improving disease management and medication compliance.

This study is designed as a randomized controlled trial to evaluate the impact of an educational program using both an animated video and an illustrated booklet developed specifically for children aged 7 to 11 with a diagnosis of asthma. The intervention focuses on key topics such as asthma triggers, correct inhaler use, symptom recognition, and medication adherence strategies.

Participants will be randomly assigned to either an intervention group receiving the animation and booklet-based education or a control group receiving standard care. Asthma control levels and medication adherence will be measured before and after the intervention using validated scales.

The findings of this study are expected to contribute to the development of child-friendly, visual educational tools that can be used by healthcare professionals in routine asthma care to enhance disease understanding, improve symptom control, and foster treatment adherence in pediatric populations.

Вмешательства

  • Поведенческое Asthma Education - Animated Video
    This intervention consists of a 7-minute and 39-second animated video titled "Living with Asthma," specifically designed for children aged 7 to 11. The video features two characters, Mert and Robo, who explain asthma, its symptoms, triggers, and correct inhaler techniques in a child-friendly manner. The content is based on the latest GINA (2020) and NHLBI (2020) guidelines. The video is first watched in the clinic setting using a tablet device and then shared with parents via WhatsApp, email, or
  • Поведенческое Booklet Group
    This intervention involves the distribution of a 12-page, full-color, illustrated educational booklet titled "Living with Asthma," developed for children aged 7 to 11. The booklet covers topics such as asthma symptoms, triggers, medication use, and device techniques using simple language and visual aids. Its content was developed in line with GINA (2020) and National Heart, Lung, and Blood Institute (2020) recommendations. During the initial clinic visit, children and parents are introduced to t

Первичные конечные точки

  • Asthma control score (Childhood Asthma Control Test - C-ACT) [Срок оценки: Baseline, 1st month, and 2nd month follow-up]
  • Medication Adherence (MARS-5) [Срок оценки: Baseline, 1st month, and 2nd month follow-up]

Критерии участия

Критерии включения

  • Children aged between 7 and 11 years
  • Diagnosed with asthma by a pediatric allergy specialist
  • Mild or moderate asthma severity according to GINA criteria
  • No communication difficulties
  • Have not received any asthma-related education outside of routine clinical care during the study period
  • No known mental or neurological disabilities
  • No serious chronic illness other than asthma (e.g., cardiac, neurological conditions)
  • At least one parent owns a smartphone or tablet
  • Child and parent volunteer to participate and provide informed consent

Критерии исключения

  • Children younger than 7 or older than 11
  • Severe persistent asthma according to GINA criteria
  • Communication difficulties
  • Prior asthma education outside of routine clinical care
  • Children with cognitive or neurological impairments
  • Children who frequently require emergency care due to asthma exacerbations
  • Families without access to communication tools (e.g., no internet, smartphone, or unable to communicate)
  • Lack of consent from either the child or parent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Turkey (Türkiye) · 1 центр
  • Trakya University Faculty of Health Sciences — Edirne

Идентификаторы

NCT: NCT06909318 · TUTF-SBF-ENK-06

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗