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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

Tracking Information
First Submitted Date  ICMJE April 27, 2018
First Posted Date  ICMJE May 10, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE April 3, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
AJD questionnaire (Aide aux Jeunes Diabètes) [ Time Frame: 3 months ]
50 questions (disease, treatment, food,…)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03520855 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • HbA1c dosage [ Time Frame: 3 months ]
    Glycemia follow-up with a self-monitoring book in each arm
  • Number of hypo or hyperglycaemia [ Time Frame: 3 months ]
    Statement of the number of hypo or hyperglycaemia within the months preceding the consultation
  • Evaluation of self-care skills [ Time Frame: 3 months ]
    Evaluation of self-care skills with role-plays (scorecard, Barrow chart)
  • Evaluation of well-being with WHOFIVE [ Time Frame: 3 months ]
    Evaluation of patient's well-being with auto-questionnaires
  • Evaluation of well-being with DQOLY [ Time Frame: 3 months ]
    Evaluation of patient's well-being with auto-questionnaires
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
Official Title  ICMJE Contribution of a Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Experimental: ETP + Serious game
    patients receiving the serious game additionally to the classic therapeutic education
    Interventions:
    • Other: Serious game
    • Behavioral: ETP
  • Active Comparator: ETP
    patients under classic therapeutic education
    Intervention: Behavioral: ETP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520855
Other Study ID Numbers  ICMJE K150907J
2017-A02052-51 ( Registry Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques BELTRAND, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP