Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
- Conditions
- Type 1 Diabetes
- Interventions
- Other: Serious gameBehavioral: ETP
- Registration Number
- NCT03520855
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ETP + Serious game Serious game patients receiving the serious game additionally to the classic therapeutic education ETP + Serious game ETP patients receiving the serious game additionally to the classic therapeutic education ETP ETP patients under classic therapeutic education
- Primary Outcome Measures
Name Time Method Diapason questionnaire (Aide aux Jeunes Diabètes) 3 months 50 questions (disease, treatment, food,...)
- Secondary Outcome Measures
Name Time Method Number of hypo or hyperglycaemia 3 months Statement of the number of hypo or hyperglycaemia within the months preceding the consultation
Evaluation of well-being with WHOFIVE 3 months Evaluation of patient's well-being with auto-questionnaires
Evaluation of well-being with DQOLY 3 months Evaluation of patient's well-being with auto-questionnaires
Evaluation of self-care skills 3 months Evaluation of self-care skills with role-plays and assessment of feelings of competence from their DT1 (scorecard, Barrow chart )
HbA1c dosage 3 months Glycemia follow-up with a self-monitoring book in each arm
Trial Locations
- Locations (1)
Necker Hospital
🇫🇷Paris, France