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

Primary Purpose

Diabetes Mellitus, Type I, Program Evaluation, Therapeutic Education

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DIAPASON Questionnaire
WHO-5
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type I focused on measuring Evaluation, Therapeutic education, Type 1 Diabetes, Children

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GHRMSA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Enrolled patient

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evolution of glycated hemoglobin
Occurrence of severe hypoglycemic events
Occurrence of ketoacidosis events
Need for care indicators
Visits to the emergency room of a hospital, consultation with general practitioner
Behavioral indicators
Evaluation of diabètes self-management, participation to therapeutic programs
Psychological indicators
quality of life questionnaire for patient and parent

Full Information

First Posted
October 7, 2016
Last Updated
August 20, 2019
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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1. Study Identification

Unique Protocol Identification Number
NCT02970357
Brief Title
Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 26, 2016 (Actual)
Primary Completion Date
March 20, 2017 (Actual)
Study Completion Date
March 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type I, Program Evaluation, Therapeutic Education, Children
Keywords
Evaluation, Therapeutic education, Type 1 Diabetes, Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enrolled patient
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DIAPASON Questionnaire
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
WHO-5
Other Intervention Name(s)
Quality of Life Questionnaire
Intervention Description
5 item questionnaire of the World Health Organization about quality of life
Primary Outcome Measure Information:
Title
The DIAPASON questionnaire
Description
50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease. Questionnaire submitted to patients and a parent.
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.
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Need for care indicators
Description
Visits to the emergency room of a hospital, consultation with general practitioner
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
Title
Behavioral indicators
Description
Evaluation of diabètes self-management, participation to therapeutic programs
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
Title
Psychological indicators
Description
quality of life questionnaire for patient and parent
Time Frame
On day 1, at enrollment, and 10months later, at the end of the study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatiha GUEMAZI-KHEFFI, MD
Organizational Affiliation
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHRMSA
City
Mulhouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
11743505
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.
Results Reference
background
PubMed Identifier
12403224
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.
Results Reference
background
PubMed Identifier
11279717
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.
Results Reference
background
PubMed Identifier
21635284
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.
Results Reference
background
Citation
Ivernois JF d', Gagnayre R. Apprendre à éduquer le patient : Approche pédagogique. 4ème édition. Maloine:2011. 160p.
Results Reference
background
Links:
URL
http://www.euro.who.int/__data/assets/pdf_file/0007/145294/E63674.pdf
Description
World Health Organization Working Group - Therapeutic Patient education Continuing Education Programmes for Health Care Providers in the Field of Prevention of Chronic Diseases

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

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