Clinical trial NCT02970357: Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes
Official title: Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type I
Program Evaluation
Therapeutic Education
Children
Keywords: Evaluation
Therapeutic education
Type 1 Diabetes
Children
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 68
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The DIAPASON questionnaire
timeFrame: 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:
measure: Evolution of glycated hemoglobin
timeFrame: 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
measure: Occurrence of severe hypoglycemic events
timeFrame: 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
measure: Occurrence of ketoacidosis events
timeFrame: 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
measure: Need for care indicators
timeFrame: 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
measure: Behavioral indicators
timeFrame: 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
measure: Psychological indicators
timeFrame: On day 1, at enrollment, and 10months later, at the end of the study participation
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA
Study officials:
affiliation: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
name: Fatiha GUEMAZI-KHEFFI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: White NH, Cleary PA, Dahms W, Goldstein D, Malone J, Tamborlane WV; Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr. 2001 Dec;139(6):804-12. doi: 10.1067/mpd.2001.118887.
citation: Likitmaskul S, Wekawanich J, Wongarn R, Chaichanwatanakul K, Kiattisakthavee P, Nimkarn S, Prayongklin S, Weerakulwattana L, Markmaitree D, Ritjarean Y, Pookpun W, Punnakanta L, Angsusingha K, Tuchinda C. Intensive diabetes education program and multidisciplinary team approach in management of newly diagnosed type 1 diabetes mellitus: a greater patient benefit, experience at Siriraj Hospital. J Med Assoc Thai. 2002 Aug;85 Suppl 2:S488-95.
citation: Renders CM, Valk GD, Griffin S, Wagner EH, Eijk JT, Assendelft WJ. Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings. Cochrane Database Syst Rev. 2001;2000(1):CD001481. doi: 10.1002/14651858.CD001481.
citation: Kelo M, Martikainen M, Eriksson E. Self-care of school-age children with diabetes: an integrative review. J Adv Nurs. 2011 Oct;67(10):2096-108. doi: 10.1111/j.1365-2648.2011.05682.x. Epub 2011 Jun 2.
citation: Ivernois JF d', Gagnayre R. Apprendre à éduquer le patient : Approche pédagogique. 4ème édition. Maloine:2011. 160p.