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Trial record 21 of 1487 for:    Type 1 Diabetes Mellitus 5

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

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ClinicalTrials.gov Identifier: NCT02970357
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type I Program Evaluation Therapeutic Education Children Other: DIAPASON Questionnaire Behavioral: WHO-5 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study
Actual Study Start Date : January 26, 2016
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Enrolled patient
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

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
Other Name: Quality of Life Questionnaire




Primary Outcome Measures :
  1. The DIAPASON questionnaire [ Time Frame: 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 :
  1. Evolution of glycated hemoglobin [ Time Frame: 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 ]
  2. Occurrence of severe hypoglycemic events [ Time Frame: 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 ]
  3. Occurrence of ketoacidosis events [ Time Frame: 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 ]
  4. Need for care indicators [ Time Frame: 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

  5. Behavioral indicators [ Time Frame: 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

  6. Psychological indicators [ Time Frame: On day 1, at enrollment, and 10months later, at the end of the study participation ]
    quality of life questionnaire for patient and parent



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970357


Locations
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France
GHRMSA
Mulhouse, France
Sponsors and Collaborators
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Investigators
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Principal Investigator: Fatiha GUEMAZI-KHEFFI, MD Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

Additional Information:
Publications:
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Responsible Party: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
ClinicalTrials.gov Identifier: NCT02970357     History of Changes
Other Study ID Numbers: 805
2015-A017101-48 ( Other Identifier: France: Agence Nationale de Sécurité du Médicament et des produits de santé )
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace:
Evaluation
Therapeutic education
Type 1 Diabetes
Children
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases