<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/NCT03786549</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0039</org_study_id>
    <secondary_id>2018-A02198-47</secondary_id>
    <nct_id>NCT03786549</nct_id>
  </id_info>
  <brief_title>Pediatric -Adult Care Transition Program of Patients With Sickle Cell Disease</brief_title>
  <acronym>DREPADO</acronym>
  <official_title>Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background The pediatric-adult care transition is a risk-disrupting time for patients with&#xD;
      chronic disease. This care transition takes place during adolescence; a period of&#xD;
      psychological upheavals and adaptations of family roles. During this period, medication&#xD;
      adherence is non-optimal and absenteeism at medical appointments is high.&#xD;
&#xD;
      Sickle cell disease (SCD) is the first genetic disease detected in France. It is chronic&#xD;
      disease characterized by frequent painful vaso-occlusive crises (VOC) requiring emergency&#xD;
      hospitalization when they are severe. Other serious complications are acute chest syndromes&#xD;
      (ACS) and stroke.&#xD;
&#xD;
      In order to improve the health status of teenagers with sickle cell disease, it is necessary&#xD;
      to anticipate this care transition and to involve the pediatric and adult sectors. The&#xD;
      biopsychosocial health approach and the Social-Ecological Model of Adolescent and Young Adult&#xD;
      Readiness to Transition (SMART) describe a care transition integrating bioclinical and&#xD;
      psychosocial factors such as integration of the patient's family, education on disease and&#xD;
      therapeutics, psychological management of pain and medico-social orientation.&#xD;
&#xD;
      The pediatric-adult transition program proposed is based on this biopsychosocial approach. It&#xD;
      aims to improve the health status of adolescents with SCD, their quality of life and the use&#xD;
      of health care service.&#xD;
&#xD;
      Objective of the study To assess the impact of a pediatric-adult transition program on the&#xD;
      incidence of sickle-cell-related complications leading to hospitalization on 24-months after&#xD;
      transfer to the adult sector.&#xD;
&#xD;
      The evaluation focuses on severe complications leading to hospitalization, such as VOC, ACS,&#xD;
      and stroke.&#xD;
&#xD;
      Study design Multicenter Open-label individual Randomized Controlled Trial Population :&#xD;
      Patients aged at least 16 years old with sickle cell disease, and their parents (or legal&#xD;
      representatives Number of subject : 196 patients (98 patients by arm) The study will last 24&#xD;
      months Expected results For patients and families Better health and quality of life for&#xD;
      patients is expected, including better use of medical care after the transition program. It&#xD;
      is also expected a better experience of the pediatric-adult care transition and indirectly a&#xD;
      better experience of intrafamilial relations.&#xD;
&#xD;
      For health professionals This project is expected to provide solutions to improve the&#xD;
      pediatric-adult care transition of patients with chronic disease. Indeed, the methodological&#xD;
      quality of the study will make it possible to evaluate the efficiency of the proposed&#xD;
      program, to possibly adapt it and test it to other chronic diseases presenting the same care&#xD;
      transition problematic.&#xD;
&#xD;
      In terms of public health SCD mainly affects populations of sub-Saharan origin, with low&#xD;
      visibility and high social vulnerability. By focusing on this population, this project will&#xD;
      reduce the social inequalities in health, experienced by patients with SCD and their&#xD;
      families.&#xD;
&#xD;
      By improving the health, quality of life and care of patients with SCD, this project is&#xD;
      expected to decrease the cost of the pediatric-adult care transition period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">April 16, 2027</completion_date>
  <primary_completion_date type="Anticipated">April 16, 2027</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of sickle cell related severe complications leading to hospitalization</measure>
    <time_frame>Within 24 months after transfer to the adult sector</time_frame>
    <description>Number of hospital admission or emergency visit in the index hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of emergency visits in the index hospital</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Frequency of emergency visits in the index hospital Within inclusion and transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of emergency visits in the index hospital</measure>
    <time_frame>Within 12 months after transfer to the adult sector</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of emergency visits in the index hospital</measure>
    <time_frame>Within 12 and 24 months after transfer to the adult sector</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Intake Survey-Asthma (MIS-A) questionnaire score</measure>
    <time_frame>At inclusion</time_frame>
    <description>Medication adherence evaluation at inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Rating Scale (MARS) questionnaire score</measure>
    <time_frame>At inclusion</time_frame>
    <description>Medication adherence evaluation at inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MIS-A questionnaire score</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Medication adherence evaluation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MARS questionnaire score</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Medication adherence evaluation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MIS-A questionnaire score</measure>
    <time_frame>within 12 months after transfer to the adult sector</time_frame>
    <description>Medication adherence evaluation within 12 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MARS questionnaire score</measure>
    <time_frame>within 12 months after transfer to the adult sector</time_frame>
    <description>This score will allow medication adherence evaluation within 12 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MIS-A questionnaire score</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Medication adherence evaluation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MARS questionnaire score</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Medication adherence evaluation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days absent at school</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Scholarly Absenteeism evaluation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days absent at school</measure>
    <time_frame>within 12 months after transfer to the adult sector</time_frame>
    <description>Scholarly Absenteeism evaluation within 12 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days absent at school</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life (WHOQOL) questionnaire score</measure>
    <time_frame>At inclusion</time_frame>
    <description>Quality of Life evaluation At inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHOQOL questionnaire score</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Quality of Life evaluation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHOQOL questionnaire score</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Quality of Life evaluation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EUropean Health Literacy questionnaire (HLS-EU-Q16) score</measure>
    <time_frame>At inclusion</time_frame>
    <description>This will allow Health Literacy evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HLS-EU-Q16 score</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Health Literacy evaluation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HLS-EU-Q16 score</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Health Literacy evaluation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease knowledge</measure>
    <time_frame>At inclusion</time_frame>
    <description>Questionnaire developed for this study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease knowledge</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Questionnaire developed for this study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease knowledge</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Questionnaire developed for this study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient activation measure-13 items questionnaire score</measure>
    <time_frame>At inclusion</time_frame>
    <description>Patient activation At inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient activation measure-13 items questionnaire score</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Patient activation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient activation measure-13 items questionnaire score</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Patient activation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score</measure>
    <time_frame>At inclusion</time_frame>
    <description>Self efficacy evaluation at inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCD-SES questionnaire score</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Self efficacy evaluation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCD-SES questionnaire score</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Self efficacy evaluation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transition readiness assessment questionnaire (TRAQ) questionnaire score</measure>
    <time_frame>At inclusion</time_frame>
    <description>Transition readiness evaluation at inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TRAQ questionnaire score</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Transition readiness evaluation At transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TRAQ questionnaire score</measure>
    <time_frame>within 24 months after transfer to the adult sector</time_frame>
    <description>Transition readiness evaluation within 24 months after transfer to the adult sector</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost effectiveness ratio</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Cost analysis at the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of pediatric-adult transition program sessions performed</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>number of interventions performed per patient and date of implementation At the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>type of pediatric-adult transition program sessions performed</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>type of interventions performed per patient and date of implementation At the end of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">196</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients included in this arm wil have usual follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Care transitional program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients included in this arm will get a care transitional program. Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent&#xD;
Three axes are :&#xD;
Educative, family (patient and parent), at home&#xD;
Psychological, with the patient individually&#xD;
Medico-social orientation, group of patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pediatric-adult care transition program</intervention_name>
    <description>Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent&#xD;
Three axes are :&#xD;
Educative, family (patient and parent), at home&#xD;
Psychological, with the patient individually&#xD;
Medico-social orientation, group of patients</description>
    <arm_group_label>Care transitional program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For patients :&#xD;
&#xD;
          -  Age: 16-17 years,&#xD;
&#xD;
          -  With major sickle cell syndrome, defined by hemoglobinopathy of homozygosity SS, or&#xD;
             double heterozygosity SC or Sβ-thalassemia,&#xD;
&#xD;
          -  Benefiting from social insurance of the type &quot;Affection of long duration&quot; (ALD).&#xD;
&#xD;
        For family members :&#xD;
&#xD;
          -  Included children's parents or legal representatives,&#xD;
&#xD;
          -  Accepting to participate in the study and having signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presenting a cognitive or psychiatric disorder known and major that may hinder&#xD;
             interventions or evaluation, the judgment of the investigator, and / or having a&#xD;
             family history with this type of disorders,&#xD;
&#xD;
          -  Cured of SCD by an allograft of hematopoietic stem cells.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alexandra GAUTHIER VASSEROT, DR</last_name>
    <phone>04 69 16 65 72</phone>
    <phone_ext>+33</phone_ext>
    <email>alexandra.gauthier@ihope.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sandrine TOUZET, Dr</last_name>
    <phone>04 72 11 57 61</phone>
    <phone_ext>+33</phone_ext>
    <email>sandrine.touzet@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Fort de France</name>
      <address>
        <city>Fort-de-France-La Martinique</city>
        <state>La Martinique</state>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gisèle ELANA, MD</last_name>
    </contact>
    <investigator>
      <last_name>Gisèle ELANA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal de Creteil</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Corinne Pondarre</last_name>
    </contact>
    <investigator>
      <last_name>Corinne Pondarre</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Frédéric Galactéros</last_name>
    </contact>
    <investigator>
      <last_name>Frédéric Galactéros</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Corinne Guitton</last_name>
    </contact>
    <investigator>
      <last_name>Corinne Guitton</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christelle Chantalat</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Gauthier- Vasserot</last_name>
    </contact>
    <contact_backup>
      <last_name>Giovanna Cannas</last_name>
    </contact_backup>
    <investigator>
      <last_name>Alexandra Gauthier- Vasserot</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giovanna Cannas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean- Benoît Arlet</last_name>
    </contact>
    <investigator>
      <last_name>Jean- Benoît Arlet</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marianne De Montalembert</last_name>
    </contact>
    <investigator>
      <last_name>Marianne De Montalembert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Pontoise</name>
      <address>
        <city>Pontoise</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Stéphanie Eyssette- Guerreau</last_name>
    </contact>
    <investigator>
      <last_name>Stéphanie Eyssette- Guerreau</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent Blum</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sickle cell disease (SDC)</keyword>
  <keyword>Pediatric-adult care transition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT03786549
org study id: 69HCL18_0039
secondary id: 2018-A02198-47
nct id: NCT03786549
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background The pediatric-adult care transition is a risk-disrupting time for patients with
      chronic disease. This care transition takes place during adolescence; a period of
      psychological upheavals and adaptations of family roles. During this period, medication
      adherence is non-optimal and absenteeism at medical appointments is high.

      Sickle cell disease (SCD) is the first genetic disease detected in France. It is chronic
      disease characterized by frequent painful vaso-occlusive crises (VOC) requiring emergency
      hospitalization when they are severe. Other serious complications are acute chest syndromes
      (ACS) and stroke.

      In order to improve the health status of teenagers with sickle cell disease, it is necessary
      to anticipate this care transition and to involve the pediatric and adult sectors. The
      biopsychosocial health approach and the Social-Ecological Model of Adolescent and Young Adult
      Readiness to Transition (SMART) describe a care transition integrating bioclinical and
      psychosocial factors such as integration of the patient's family, education on disease and
      therapeutics, psychological management of pain and medico-social orientation.

      The pediatric-adult transition program proposed is based on this biopsychosocial approach. It
      aims to improve the health status of adolescents with SCD, their quality of life and the use
      of health care service.

      Objective of the study To assess the impact of a pediatric-adult transition program on the
      incidence of sickle-cell-related complications leading to hospitalization on 24-months after
      transfer to the adult sector.

      The evaluation focuses on severe complications leading to hospitalization, such as VOC, ACS,
      and stroke.

      Study design Multicenter Open-label individual Randomized Controlled Trial Population :
      Patients aged at least 16 years old with sickle cell disease, and their parents (or legal
      representatives Number of subject : 196 patients (98 patients by arm) The study will last 24
      months Expected results For patients and families Better health and quality of life for
      patients is expected, including better use of medical care after the transition program. It
      is also expected a better experience of the pediatric-adult care transition and indirectly a
      better experience of intrafamilial relations.

      For health professionals This project is expected to provide solutions to improve the
      pediatric-adult care transition of patients with chronic disease. Indeed, the methodological
      quality of the study will make it possible to evaluate the efficiency of the proposed
      program, to possibly adapt it and test it to other chronic diseases presenting the same care
      transition problematic.

      In terms of public health SCD mainly affects populations of sub-Saharan origin, with low
      visibility and high social vulnerability. By focusing on this population, this project will
      reduce the social inequalities in health, experienced by patients with SCD and their
      families.

      By improving the health, quality of life and care of patients with SCD, this project is
      expected to decrease the cost of the pediatric-adult care transition period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Incidence of sickle cell related severe complications leading to hospitalization
time frame: Within 24 months after transfer to the adult sector
description: Number of hospital admission or emergency visit in the index hospital
measure: Frequency of emergency visits in the index hospital
time frame: Up to 2 years
description: Frequency of emergency visits in the index hospital Within inclusion and transfer to the adult sector
measure: Frequency of emergency visits in the index hospital
time frame: Within 12 months after transfer to the adult sector
measure: Frequency of emergency visits in the index hospital
time frame: Within 12 and 24 months after transfer to the adult sector
measure: Medication Intake Survey-Asthma (MIS-A) questionnaire score
time frame: At inclusion
description: Medication adherence evaluation at inclusion
measure: Medication Rating Scale (MARS) questionnaire score
time frame: At inclusion
description: Medication adherence evaluation at inclusion
measure: MIS-A questionnaire score
time frame: Up to 2 years
description: Medication adherence evaluation At transfer to the adult sector
measure: MARS questionnaire score
time frame: Up to 2 years
description: Medication adherence evaluation At transfer to the adult sector
measure: MIS-A questionnaire score
time frame: within 12 months after transfer to the adult sector
description: Medication adherence evaluation within 12 months after transfer to the adult sector
measure: MARS questionnaire score
time frame: within 12 months after transfer to the adult sector
description: This score will allow medication adherence evaluation within 12 months after transfer to the adult sector
measure: MIS-A questionnaire score
time frame: within 24 months after transfer to the adult sector
description: Medication adherence evaluation within 24 months after transfer to the adult sector
measure: MARS questionnaire score
time frame: within 24 months after transfer to the adult sector
description: Medication adherence evaluation within 24 months after transfer to the adult sector
measure: Number of days absent at school
time frame: Up to 2 years
description: Scholarly Absenteeism evaluation At transfer to the adult sector
measure: Number of days absent at school
time frame: within 12 months after transfer to the adult sector
description: Scholarly Absenteeism evaluation within 12 months after transfer to the adult sector
measure: Number of days absent at school
time frame: within 24 months after transfer to the adult sector
description: Scholarly Absenteeism evaluation within 24 months after transfer to the adult sector
measure: World Health Organization Quality of Life (WHOQOL) questionnaire score
time frame: At inclusion
description: Quality of Life evaluation At inclusion
measure: WHOQOL questionnaire score
time frame: Up to 2 years
description: Quality of Life evaluation At transfer to the adult sector
measure: WHOQOL questionnaire score
time frame: within 24 months after transfer to the adult sector
description: Quality of Life evaluation within 24 months after transfer to the adult sector
measure: EUropean Health Literacy questionnaire (HLS-EU-Q16) score
time frame: At inclusion
description: This will allow Health Literacy evaluation
measure: HLS-EU-Q16 score
time frame: Up to 2 years
description: Health Literacy evaluation At transfer to the adult sector
measure: HLS-EU-Q16 score
time frame: within 24 months after transfer to the adult sector
description: Health Literacy evaluation within 24 months after transfer to the adult sector
measure: Disease knowledge
time frame: At inclusion
description: Questionnaire developed for this study
measure: Disease knowledge
time frame: Up to 2 years
description: Questionnaire developed for this study
measure: Disease knowledge
time frame: within 24 months after transfer to the adult sector
description: Questionnaire developed for this study
measure: Patient activation measure-13 items questionnaire score
time frame: At inclusion
description: Patient activation At inclusion
measure: Patient activation measure-13 items questionnaire score
time frame: Up to 2 years
description: Patient activation At transfer to the adult sector
measure: Patient activation measure-13 items questionnaire score
time frame: within 24 months after transfer to the adult sector
description: Patient activation within 24 months after transfer to the adult sector
measure: Self efficacy specific instrument - sickle cell disease (SCD-SES) questionnaire score
time frame: At inclusion
description: Self efficacy evaluation at inclusion
measure: SCD-SES questionnaire score
time frame: Up to 2 years
description: Self efficacy evaluation At transfer to the adult sector
measure: SCD-SES questionnaire score
time frame: within 24 months after transfer to the adult sector
description: Self efficacy evaluation within 24 months after transfer to the adult sector
measure: Transition readiness assessment questionnaire (TRAQ) questionnaire score
time frame: At inclusion
description: Transition readiness evaluation at inclusion
measure: TRAQ questionnaire score
time frame: Up to 2 years
description: Transition readiness evaluation At transfer to the adult sector
measure: TRAQ questionnaire score
time frame: within 24 months after transfer to the adult sector
description: Transition readiness evaluation within 24 months after transfer to the adult sector
measure: cost effectiveness ratio
time frame: Up to 4 years
description: Cost analysis at the end of the study
measure: number of pediatric-adult transition program sessions performed
time frame: Up to 4 years
description: number of interventions performed per patient and date of implementation At the end of the study
measure: type of pediatric-adult transition program sessions performed
time frame: Up to 4 years
description: type of interventions performed per patient and date of implementation At the end of the study
arm group label: Control
arm group type: No Intervention
description: Patients included in this arm wil have usual follow-up.
arm group label: Care transitional program
arm group type: Experimental
description: Patients included in this arm will get a care transitional program. Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent
Three axes are :
Educative, family (patient and parent), at home
Psychological, with the patient individually
Medico-social orientation, group of patients
intervention type: Other
intervention name: pediatric-adult care transition program
description: Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent
Three axes are :
Educative, family (patient and parent), at home
Psychological, with the patient individually
Medico-social orientation, group of patients
arm group label: Care transitional program
criteria: 
gender: All
minimum age: 16 Years
maximum age: 17 Years
healthy volunteers: No
last name: Alexandra GAUTHIER VASSEROT, DR
phone: 04 69 16 65 72
phone ext: +33
email: alexandra.gauthier@ihope.fr
last name: Sandrine TOUZET, Dr
phone: 04 72 11 57 61
phone ext: +33
email: sandrine.touzet@chu-lyon.fr
facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
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status: Recruiting
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country: France
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell