Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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 . To measure the impact of the serious game,investigators will compare HbA1c dosage between groups (with HPLC technique), 3 months after diagnosis; but also the number of hypo or hyperglycaemia in the month before M3 final consultation. They will also evaluate self-care skills and safety skills with role-plays at the end of hospitalisation and 3 months later. Technical gestures will also be evaluated by referent nurses. Evaluation of the patient's well-being will take place with two types of questionnaire, WHO-Five and DOQLY during M3 final consultation. This research will bring essential information on the development of video games in other paediatric chronic diseases, as a first step in the development of the use of video games in therapeutic care of type 1 diabetes.

Official Title
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Contribution of a Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Serious game
* Behavioral: ETP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETP + Serious game<br>patients receiving the serious game additionally to the classic therapeutic education | Other: Serious game<br>* DIVE software will be accessible via internet, children and parents will have to their disposition a room at the hospital specifically to work on the software. The DIVE software is organized in chapters, each matches an item of the therapeutic education process and ends with a knowledge assessment. The child has to end every chapter and succeed every evaluation to pursue on the next chapter. Measures will be taken in order to avoid contamination bias between groups. Children will have to connect to DIVE 2 times per week for a time duration of at last 1 hour.<br>Behavioral: ETP<br>* Initial therapeutic education only will be applied in this group, with the help of doctors and nurses, based on theoretical educational lessons, reported on the AJD book. Health education sessions will also be taught by nurses.<br>|
| Active Comparator: ETP<br>patients under classic therapeutic education | Behavioral: ETP<br>* Initial therapeutic education only will be applied in this group, with the help of doctors and nurses, based on theoretical educational lessons, reported on the AJD book. Health education sessions will also be taught by nurses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diapason questionnaire (Aide aux Jeunes Diabètes) | 50 questions (disease, treatment, food,…) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c dosage | Glycemia follow-up with a self-monitoring book in each arm | 3 months | 
| Number of hypo or hyperglycaemia | Statement of the number of hypo or hyperglycaemia within the months preceding the consultation | 3 months | 
| Evaluation of self-care skills | Evaluation of self-care skills with role-plays and assessment of feelings of competence from their DT1 (scorecard, Barrow chart ) | 3 months | 
| Evaluation of well-being with WHOFIVE | Evaluation of patient's well-being with auto-questionnaires | 3 months | 
| Evaluation of well-being with DQOLY | Evaluation of patient's well-being with auto-questionnaires | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Paediatrics patients