Interactive Educational Video for Paediatric Type 1 Diabetes

Официальное название

The Efficacy of Interactive Videos in the Education of Paediatric Patients With Type 1 Diabetes: A Randomised Controlled Trial.

Обзор

The primary aim of this study is to evaluate the effectiveness of an interactive educational video (Luca's Journey: Managing Type 1 Diabetes) delivered in addition to the standard educational programme, in improving metabolic control in children with type 1 diabetes mellitus, specifically focusing on the change in glycated haemoglobin (HbA1c) levels between baseline (T0) and six-month follow-up (T3). The study will also assess the effectiveness of the intervention in improving fasting blood glucose levels, frequency of hypoglycaemic and hyperglycaemic episodes, clinical and anthropometric variables (blood pressure, body weight, BMI, and waist circumference), acquisition of nutritional knowledge based on recommendations for the management of type 1 diabetes, and adherence to the main type 1 diabetes management activities. The secondary objectives were to compare the two educational modalities (intervention vs. standard educational programme) in terms of: (i) mean between-group difference in the change in fasting blood glucose levels and frequency of hypoglycaemic and hyperglycaemic episodes; (ii) mean between-group difference in the change in clinical and anthropometric variables; (iii) acquisition of nutritional knowledge based on recommendations for the management of type 1 diabetes; and (iv) adherence to the main type 1 diabetes management activities. The main research questions addressed in this study are: Does the interactive educational video improve metabolic control, as measured by HbA1c levels, in children with type 1 diabetes compared to standard education alone? Does the intervention lead to a greater reduction in fasting blood glucose levels and a lower frequency of hypoglycaemic and hyperglycaemic episodes? Does the intervention improve clinical and anthropometric variables compared to standard education alone? Does the intervention lead to a greater acquisition of nutritional knowledge in children with type 1 diabetes? Does the intervention improve adherence to the main type 1 diabetes management activities, including insulin administration, blood glucose monitoring, dietary behaviours, and physical activity? Both study groups will receive the standard in-person educational programme, as routinely delivered at the outpatient clinic of the Regional Centre for Paediatric Diabetology of the "SS. Annunziata" University Hospital in Chieti. Participants assigned to the intervention group will additionally receive a 25-minute interactive educational video immediately following the standard educational session. The interactive video follows a child with type 1 diabetes through everyday situations, inviting participants to make decisions at key moments and explore the consequences of different behavioural choices related to diabetes management.

Вмешательства

• Другое Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes)
  The interactive educational video intervention will be tailored to the cognitive and developmental characteristics of the target age group (8-14 years), adapting content complexity, language, narrative structure, and interactive elements to ensure comprehensibility and engagement, while maintaining consistent educational goals across participants. Understanding will be supported through immediate visual feedback following each interactive choice, explaining in simple terms the consequences of ea
• Другое Traditional Face-to-Face Education
  The standard face-to-face educational session will be tailored to the cognitive and developmental characteristics of the target age group (8-14 years), adapting content complexity, language, and communication style to ensure comprehensibility and engagement, while maintaining consistent educational goals across participants. Understanding will be supported through verbal interaction and age-appropriate explanations provided by the paediatric nurse and diabetologist. The educational session cover

Первичные конечные точки

• Change in glycated haemoglobin (HbA1c) levels from baseline to 6-month follow-up [Срок оценки: Assessed at Baseline (T0) and 6 months (T3).]

Вторичные конечные точки (9)

• Change in Fasting Blood Glucose (FBS) levels from baseline to 6-month follow-up [Срок оценки: Assessed at baseline (T0) and 6 months (T3)]
• Change in Frequency of Hypoglycaemic Episodes (Mild, Moderate, and Severe) Assessed by Glycaemic Monitoring Devices or Fingerstick From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0) and 6 months (T3)]
• Change in Frequency of Hyperglycaemic Episodes (Mild, Moderate, and Severe) Assessed by Glycaemic Monitoring Devices or Fingerstick From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0) and 6 months (T3)]
• Change in Blood Pressure (Systolic and Diastolic) Assessed by Standard Sphygmomanometer From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0) and 6 months (T3)]
• Change in Body Weight Assessed by Standard Scale From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0) and 6 months (T3)]
• Change in Body Mass Index (BMI) Calculated From Height and Weight Measurements From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0) and at six-month follow-up (T3)]
• Change in Waist Circumference Assessed by Standard Tape Measure From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0) and at six-month follow-up (T3)]
• Change in Nutritional Knowledge Assessed by the Nutrition Knowledge Survey (NKS) From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0), immediately post-intervention (T1), three months post-intervention (T2), and at six-month follow-up (T3).]
• Change in Adherence to Diabetes Management Activities Assessed by the Diabetes Management Questionnaire (DMQ) From Baseline to 6-Month Follow-up [Срок оценки: Assessed at baseline (T0), three months post-intervention (T2), and at six-month follow-up (T3)]

Критерии участия

Критерии включения

• Male and female children aged between 8 and 14 years
• Diagnosis of type 1 diabetes mellitus for at least 6 months
• Ability to understand and communicate in Italian
• Absence of psychiatric disorders
• Absence of cognitive impairment
• Ability to use digital devices (e.g., computer)
• Written informed consent for study participation and personal data-processing provided by both parents or the legal guardian

Критерии исключения

• Age younger than 8 years or older than 14 years
• Diagnosis of type 1 diabetes mellitus for less than 6 months
• Inability to understand or communicate in Italian
• Presence of psychiatric disorders
• Presence of cognitive impairment
• Inability to use digital devices (e.g., computer)
• Refusal of assent by the child
• Failure to provide written informed consent for study participation and personal data processing by both parents or the legal guardian

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07639307 · Interactive video

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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