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

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Status: Completed

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

Treatments: Other: DIAPASON Questionnaire; Behavioral: WHO-5

Study type: Interventional

Funder types: Other

Identifiers

NCT02970357

GHRMSA 805

2015-A017101-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 10 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Enrolled patient

Other group

Description:

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.

Treatment:

Behavioral: WHO-5

Other: DIAPASON Questionnaire