Diabetes Mellitus, Type I, Program Evaluation, Therapeutic Education, Children
Conditions
Keywords
Evaluation, Therapeutic education, Type 1 Diabetes, Children
Brief summary
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
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.
Interventions
OTHERDIAPASON Questionnaire
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
BEHAVIORALWHO-5
5 item questionnaire of the World Health Organization about quality of life
Sponsors
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The DIAPASON questionnaire | The outcome will be the change of the answers to the questionnaire from enrollment to the end of the study, ten months later. | 50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease. Questionnaire submitted to patients and a parent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Behavioral indicators | 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 | Evaluation of diabètes self-management, participation to therapeutic programs |
| Psychological indicators | On day 1, at enrollment, and 10months later, at the end of the study participation | quality of life questionnaire for patient and parent |
| Need for care indicators | 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 | Visits to the emergency room of a hospital, consultation with general practitioner |
Countries
France
Outcome results
None listed