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

NCT02970357 | Completed

• 2 other identifiers: GHRMSA 8052015-A017101-48
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Evaluation; Therapeutic education; Type 1 Diabetes; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  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

Study Arms (1)

Enrolled patient

OTHER

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; Behavioral: WHO-5

Interventions

DIAPASON Questionnaire OTHER

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

Enrolled patient

WHO-5 BEHAVIORAL

5 item questionnaire of the World Health Organization about quality of life

Also known as: Quality of Life Questionnaire

Enrolled patient

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrollment between January 15 to March 15, 2016
• Insulin-dependent type 1 Diabetes
• Treatment received at the Hospital of Mulhouse, France

You may not qualify if:

• Opposition to study participation
• Behavioral issues
• Uncontrolled psychological issue

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

GHRMSA

Mulhouse, France

Location

Related Links

• Study results

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fatiha GUEMAZI-KHEFFI, MD

  Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: November 22, 2016
• Study Start: January 26, 2016
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: November 20, 2025

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)