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

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ClinicalTrials.gov Identifier: NCT03520855
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Serious game Behavioral: ETP Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Contribution of a Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ETP + Serious game
patients receiving the serious game additionally to the classic therapeutic education
Other: Serious game
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.

Behavioral: ETP

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.


Active Comparator: ETP
patients under classic therapeutic education
Behavioral: ETP

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.





Primary Outcome Measures :
  1. AJD questionnaire (Aide aux Jeunes Diabètes) [ Time Frame: 3 months ]
    50 questions (disease, treatment, food,…)


Secondary Outcome Measures :
  1. HbA1c dosage [ Time Frame: 3 months ]
    Glycemia follow-up with a self-monitoring book in each arm

  2. Number of hypo or hyperglycaemia [ Time Frame: 3 months ]
    Statement of the number of hypo or hyperglycaemia within the months preceding the consultation

  3. Evaluation of self-care skills [ Time Frame: 3 months ]
    Evaluation of self-care skills with role-plays (scorecard, Barrow chart)

  4. Evaluation of well-being with WHOFIVE [ Time Frame: 3 months ]
    Evaluation of patient's well-being with auto-questionnaires

  5. Evaluation of well-being with DQOLY [ Time Frame: 3 months ]
    Evaluation of patient's well-being with auto-questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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). Diagnosis will be asserted upon classic diagnosis' criteria : venous glycaemia above 2 g/l, polyuria-polydipsia syndrome, weight loss, cetonuria (equivalent to at least one cross in urinary>0.5mmol/L en sanguin)
  • Child with internet access and with a computer 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520855


Contacts
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Contact: Nadine Lepage, MD, PhD +33 1 44 49 48 35 nadinelepage74@gmail.com
Contact: Sandra COLAS + 33 1 71 19 64 32 sandra.colas@aphp.fr

Locations
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France
Necker Hospital Recruiting
Paris, France, 75015
Contact: Jacques BELTRAND, MD, PhD    01 44 38 15 45    jacques.beltrand@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jacques BELTRAND, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03520855     History of Changes
Other Study ID Numbers: K150907J
2017-A02052-51 ( Registry Identifier: ID-RCB )
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Type 1 Diabetes
Paediatrics patients
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases