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

Children Clinical Trial

— PROGETE  

Official title:

Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970357
• Other study ID #: 805
• Secondary ID: 2015-A017101-48
• Status: Completed
• Phase: N/A
• Start date: January 26, 2016
• Est. completion date: March 20, 2017

Study information

• Verified date: July 2017
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type I
• Program Evaluation
• Therapeutic Education

Intervention

Other:
• DIAPASON 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

Behavioral:
• WHO-5
5 item questionnaire of the World Health Organization about quality of life

Locations

Country	Name	City	State
France	GHRMSA	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

References & Publications (5)

Ivernois JF d', Gagnayre R. Apprendre à éduquer le patient : Approche pédagogique. 4ème édition. Maloine:2011. 160p.

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. Review. — View 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. — View 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;(1):CD001481. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Need for care indicators	Visits to the emergency room of a hospital, consultation with general practitioner	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
Secondary	Behavioral indicators	Evaluation of diabètes self-management, participation to therapeutic programs	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
Secondary	Psychological indicators	quality of life questionnaire for patient and parent	On day 1, at enrollment, and 10months later, at the end of the study participation

External Links

•   French article about the DIAPASON questionnaire, 50 item questionnaire assessing children and teens' knowledge of the diabetes disease
•   World Health Organization Working Group - Therapeutic Patient education Continuing Education Programmes for Health Care Providers in the Field of Prevention of Chronic Diseases