Clinical trial NCT03520855: Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
Official title: Contribution of a Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Paediatrics patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 78
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diapason questionnaire (Aide aux Jeunes Diabètes)
timeFrame: 3 months
Secondary outcomes:
measure: HbA1c dosage
timeFrame: 3 months
measure: Number of hypo or hyperglycaemia
timeFrame: 3 months
measure: Evaluation of self-care skills
timeFrame: 3 months
measure: Evaluation of well-being with WHOFIVE
timeFrame: 3 months
measure: Evaluation of well-being with DQOLY
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jacques BELTRAND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: