Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients (eDIVE)
Primary Purpose
Type 1 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serious game
ETP
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Paediatrics patients
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
Sites / Locations
- Necker HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ETP + Serious game
ETP
Arm Description
patients receiving the serious game additionally to the classic therapeutic education
patients under classic therapeutic education
Outcomes
Primary Outcome Measures
Diapason questionnaire (Aide aux Jeunes Diabètes)
50 questions (disease, treatment, food,…)
Secondary Outcome Measures
HbA1c dosage
Glycemia follow-up with a self-monitoring book in each arm
Number of hypo or hyperglycaemia
Statement of the number of hypo or hyperglycaemia within the months preceding the consultation
Evaluation of self-care skills
Evaluation of self-care skills with role-plays and assessment of feelings of competence from their DT1 (scorecard, Barrow chart )
Evaluation of well-being with WHOFIVE
Evaluation of patient's well-being with auto-questionnaires
Evaluation of well-being with DQOLY
Evaluation of patient's well-being with auto-questionnaires
Full Information
NCT ID
NCT03520855
First Posted
April 27, 2018
Last Updated
October 31, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03520855
Brief Title
Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
Acronym
eDIVE
Official Title
Contribution of a Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Paediatrics patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ETP + Serious game
Arm Type
Experimental
Arm Description
patients receiving the serious game additionally to the classic therapeutic education
Arm Title
ETP
Arm Type
Active Comparator
Arm Description
patients under classic therapeutic education
Intervention Type
Other
Intervention Name(s)
Serious game
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ETP
Intervention Description
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 Measure Information:
Title
Diapason questionnaire (Aide aux Jeunes Diabètes)
Description
50 questions (disease, treatment, food,…)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HbA1c dosage
Description
Glycemia follow-up with a self-monitoring book in each arm
Time Frame
3 months
Title
Number of hypo or hyperglycaemia
Description
Statement of the number of hypo or hyperglycaemia within the months preceding the consultation
Time Frame
3 months
Title
Evaluation of self-care skills
Description
Evaluation of self-care skills with role-plays and assessment of feelings of competence from their DT1 (scorecard, Barrow chart )
Time Frame
3 months
Title
Evaluation of well-being with WHOFIVE
Description
Evaluation of patient's well-being with auto-questionnaires
Time Frame
3 months
Title
Evaluation of well-being with DQOLY
Description
Evaluation of patient's well-being with auto-questionnaires
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadine Lepage, MD, PhD
Phone
+33 1 87 89 20 68
Email
nadine.lepage@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Solimda SOTOU-BERE
Phone
+ 33 1 42 19 28 79
Email
solimda.soutoubere@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques BELTRAND, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques BELTRAND, MD, PhD
Phone
01 44 38 15 45
Email
jacques.beltrand@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients
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