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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Other: Serious game; Behavioral: ETP

Study type: Interventional

Funder types: Other

Identifiers

NCT03520855

2017-A02052-51 (Registry Identifier)

K150907J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ETP + Serious game

Experimental group

Description:

patients receiving the serious game additionally to the classic therapeutic education

Treatment:

Behavioral: ETP

Other: Serious game

ETP

Active Comparator group

Description:

patients under classic therapeutic education

Treatment:

Behavioral: ETP