<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02970357</url>
  </required_header>
  <id_info>
    <org_study_id>805</org_study_id>
    <secondary_id>2015-A017101-48</secondary_id>
    <nct_id>NCT02970357</nct_id>
  </id_info>
  <brief_title>Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes</brief_title>
  <acronym>PROGETE</acronym>
  <official_title>Evaluation of the Impact of a Therapeutic Education Program for Children With Type 1 Diabetes. A French Monocentric Prospective Study. Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier de la Region de Mulhouse et Sud Alsace</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The needs of children and teens with type 1 diabetes are very specific and different from the&#xD;
      adults with type 1 diabetes. Many organizations such as the World Health Organization or the&#xD;
      International Society for Pediatric and Adolescent Diabetes, recommend a patient therapeutic&#xD;
      education when it comes to children with type 1 diabetes.&#xD;
&#xD;
      This study aims to evaluate the impact of a therapeutic education program on theoretical&#xD;
      knowledge of the disease and also on quality of life, on biological and clinical indicators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Structuring a therapeutic education program for patients with a chronic disease was the&#xD;
      initiative of the French High Health Authority in June 2007.&#xD;
&#xD;
      The Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse&#xD;
      is a partner of the Mulhouse Hospital. Besides the usual care given at the hospital of&#xD;
      Mulhouse for patients with a type 1 diabetes, both organizations also provide therapeutic&#xD;
      education to these patients.&#xD;
&#xD;
      Each therapeutic education program is organized according to the patient's age. They can also&#xD;
      be organized in a group or individually.&#xD;
&#xD;
      The aim of the therapeutic education is to help the young patients to cope with diabetes in&#xD;
      their daily activities. Therapeutic education is known to bring good results for patients&#xD;
      with diabetes, but there is no studies in France for children and teens with a type 1&#xD;
      diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2016</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 20, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The DIAPASON questionnaire</measure>
    <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.</time_frame>
    <description>50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease. Questionnaire submitted to patients and a parent.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of glycated hemoglobin</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of severe hypoglycemic events</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of ketoacidosis events</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for care indicators</measure>
    <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</time_frame>
    <description>Visits to the emergency room of a hospital, consultation with general practitioner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral indicators</measure>
    <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</time_frame>
    <description>Evaluation of diabètes self-management, participation to therapeutic programs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological indicators</measure>
    <time_frame>On day 1, at enrollment, and 10months later, at the end of the study participation</time_frame>
    <description>quality of life questionnaire for patient and parent</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Diabetes Mellitus, Type I</condition>
  <condition>Program Evaluation</condition>
  <condition>Therapeutic Education</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Enrolled patient</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DIAPASON Questionnaire</intervention_name>
    <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 :&#xD;
what is diabetes&#xD;
Monitoring&#xD;
Hypoglycemia and Hyperglycemia&#xD;
Nutrition&#xD;
Insuline</description>
    <arm_group_label>Enrolled patient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WHO-5</intervention_name>
    <description>5 item questionnaire of the World Health Organization about quality of life</description>
    <arm_group_label>Enrolled patient</arm_group_label>
    <other_name>Quality of Life Questionnaire</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrollment between January 15 to March 15, 2016&#xD;
&#xD;
          -  Insulin-dependent type 1 Diabetes&#xD;
&#xD;
          -  Treatment received at the Hospital of Mulhouse, France&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opposition to study participation&#xD;
&#xD;
          -  Behavioral issues&#xD;
&#xD;
          -  Uncontrolled psychological issue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatiha GUEMAZI-KHEFFI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe Hospitalier de la Région de Mulhouse et Sud Alsace</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GHRMSA</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.euro.who.int/__data/assets/pdf_file/0007/145294/E63674.pdf</url>
    <description>World Health Organization Working Group - Therapeutic Patient education Continuing Education Programmes for Health Care Providers in the Field of Prevention of Chronic Diseases</description>
  </link>
  <reference>
    <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>
    <PMID>11743505</PMID>
  </reference>
  <reference>
    <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>
    <PMID>12403224</PMID>
  </reference>
  <reference>
    <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>
    <PMID>11279717</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21635284</PMID>
  </reference>
  <reference>
    <citation>Ivernois JF d', Gagnayre R. Apprendre à éduquer le patient : Approche pédagogique. 4ème édition. Maloine:2011. 160p.</citation>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Evaluation</keyword>
  <keyword>Therapeutic education</keyword>
  <keyword>Type 1 Diabetes</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02970357
org study id: 805
secondary id: 2015-A017101-48
nct id: NCT02970357
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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.
description: 50 item questionnaire that evaluates the patient's theoretical knowledge of the type 1 diabetes disease. Questionnaire submitted to patients and a parent.
measure: 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
measure: 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
measure: 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
measure: 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
description: Visits to the emergency room of a hospital, consultation with general practitioner
measure: 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
description: Evaluation of diabètes self-management, participation to therapeutic programs
measure: Psychological indicators
time frame: On day 1, at enrollment, and 10months later, at the end of the study participation
description: quality of life questionnaire for patient and parent
arm group label: Enrolled patient
arm group type: Other
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: DIAPASON Questionnaire
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
arm group label: Enrolled patient
intervention type: Behavioral
intervention name: WHO-5
description: 5 item questionnaire of the World Health Organization about quality of life
arm group label: Enrolled patient
other name: Quality of Life Questionnaire
criteria: 
gender: All
minimum age: 10 Years
maximum age: 20 Years
healthy volunteers: No
last name: Fatiha GUEMAZI-KHEFFI, MD
role: Principal Investigator
affiliation: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
facility: 
country: France
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
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.
PMID: 11743505
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.
PMID: 12403224
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.
PMID: 11279717
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.
PMID: 21635284
citation: Ivernois JF d', Gagnayre R. Apprendre à éduquer le patient : Approche pédagogique. 4ème édition. Maloine:2011. 160p.
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes