Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes

Study Overview
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Brief Summary
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The needs of children and teens with type 1 diabetes are very specific and different from the adults with type 1 diabetes. Many organizations such as the World Health Organization or the International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic education when it comes to children with type 1 diabetes. This study aims to evaluate the impact of a therapeutic education program on theoretical knowledge of the disease and also on quality of life, on biological and clinical indicators.

Detailed Description
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Structuring a therapeutic education program for patients with a chronic disease was the initiative of the French High Health Authority in June 2007. The Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse is a partner of the Mulhouse Hospital. Besides the usual care given at the hospital of Mulhouse for patients with a type 1 diabetes, both organizations also provide therapeutic education to these patients. Each therapeutic education program is organized according to the patient's age. They can also be organized in a group or individually. The aim of the therapeutic education is to help the young patients to cope with diabetes in their daily activities. Therapeutic education is known to bring good results for patients with diabetes, but there is no studies in France for children and teens with a type 1 diabetes.

Official Title
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Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study

Conditions
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Diabetes Mellitus, Type I, Program Evaluation, Therapeutic Education, Children

Intervention / Treatment
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* Other: DIAPASON Questionnaire
* Behavioral: WHO-5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment between January 15 to March 15, 2016 Insulin-dependent type 1 Diabetes Treatment received at the Hospital of Mulhouse, France Exclusion Criteria: Opposition to study participation Behavioral issues Uncontrolled psychological issue

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enrolled patient<br>Every patient of the Mulhouse Hospital with a type 1 diabetes who joins the study will be followed for 10 months. They will fill in the DIAPASON questionnaire and the quality of life WHO-5 questionnaire on the day of enrollment and 10 months after enrollment, at the end of the study. Young patients followed for a type 1 diabetes at the Mulhouse Hospital usually come every two months to see the pediatric endocrinologist, so the data collected for a regular visit will also be collected for the study every two months between the enrollment and the end of study participation. | Other: DIAPASON Questionnaire<br>* 50 item questionnaire of the French Youth Diabetes Association to evaluate one's theoretical knowledge about the diabetes disease. 6 main themes are evaluated : what is diabetes Monitoring Hypoglycemia and Hyperglycemia Nutrition Insuline<br>Behavioral: WHO-5<br>* 5 item questionnaire of the World Health Organization about quality of life<br>* Other names: Quality of Life Questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The DIAPASON questionnaire | 50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease. Questionnaire submitted to patients and a parent. | The outcome will be the change of the answers to the questionnaire from enrollment to the end of the study, ten months later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of glycated hemoglobin |  | Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation | 
| Occurrence of severe hypoglycemic events |  | Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation | 
| Occurrence of ketoacidosis events |  | Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation | 
| Need for care indicators | Visits to the emergency room of a hospital, consultation with general practitioner | Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation | 
| Behavioral indicators | Evaluation of diabètes self-management, participation to therapeutic programs | Throughout the study : on the enrollment day, 2 months after enrollment, 4 months after enrollment, 6 months after enrollment, 8 months after enrollment and 10 months after enrollment which is the end of the study participation | 
| Psychological indicators | quality of life questionnaire for patient and parent | On day 1, at enrollment, and 10months later, at the end of the study participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evaluation, Therapeutic education, Type 1 Diabetes, Children