Contribution of a Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Diapason questionnaire (Aide aux Jeunes Diabètes)
研究概览
简要总结
The aim of this study is to evaluate the contribution of a serious game in the reinforcement of knowledge acquired during therapeutic education of type 1 diabetes paediatric patients.
This evaluation will take place within 3 months of the diagnosis.
详细描述
Type 1 diabetes gather multiple metabolic pathologies secondary to a deficiency in insulin secretion or insulin action, characterized by chronic hyperglycaemia. Diagnosis is based on fasting glycaemia above 1.26 g/l or above 2 g/l any time of the day.
Currently, it is recommend initial therapeutic education additionally to insulin therapy, in the type 1 diabetes care. Initial therapeutic education's role is to develop 3 specific skills : self-care skills, safety skills and adaptation skills. This approach gives to the patient the abilities to monitor himself, to handle emergency situations and to modify his lifestyle to treat his disease correctly.
In the serious game, the patient will directly evolve in a virtual environment, with places reflecting his real life such as paediatric diabetology centre, hospital, home, school. He will have to complete quests with his own virtual avatar, that reflect situations his disease can confront him to. Each quest ends with a questionnaire.
The principal objective of this research is to evaluation the contribution of a serious game (DIVE) in the reinforcement of knowledge acquired during therapeutic education of type 1 diabetes paediatric patients.
This research is designed in two arms, gathering 100 patients, each arm has 50 patients. Both arms benefit initial therapeutic education, except the experimental group which is added a serious game .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged from 10 to 17 and 8 months
- •Child with a type 1 diabetes (inclusion within 96 hours following the diagnosis, except for patients admitted to intensive care for whom an additional 48-hour period is accepted for their inclusion). Diagnosis will be confirmed based on one of the classic diagnostic criteria: venous glycaemia above 2 g / l, presence of polyuropolydipsic syndrome, presence of weight loss, presence of ketonuria (equivalent to at least one cross in urine or> 0.5mmol / l in blood)
- •Child with internet access and with a computer or a tablet or a mobile phone in at least one of the two parents or legal representative(s)
- •Informed consent signed by parents or legal representative(s) (only one parent possible)
- •Beneficiary of a social security system
排除标准
- •No internet access or no computer or no tablet or no mobile phone at home available
- •No French language proficiency of the infant or legal representative(s)
- •Inability to understand the game's instructions
- •Inability to understand or fill the consent
结局指标
主要结局
Diapason questionnaire (Aide aux Jeunes Diabètes)
时间窗: 3 months
50 questions (disease, treatment, food,...)
次要结局
- Evaluation of well-being with DQOLY(3 months)
- Evaluation of self-care skills(3 months)
- HbA1c dosage(3 months)
- Number of hypo or hyperglycaemia(3 months)
- Evaluation of well-being with WHOFIVE(3 months)