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

Not Applicable

Completed

• Conditions: Children; Diabetes Mellitus, Type I; Therapeutic Education; Program Evaluation
• Interventions: Other: DIAPASON Questionnaire; Behavioral: WHO-5

• Registration Number: NCT02970357
• Lead Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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.

Study Timeline

• Study Start: 2016-01-26
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-22
• Primary Completion: 2017-03-20
• Study Completion: 2017-03-20
• Status Verified: 2017-07
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enrolled patient	DIAPASON Questionnaire	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.
Enrolled patient	WHO-5	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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

Trial Locations

Locations (1)

GHRMSA; 🇫🇷 Mulhouse, France