<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/NCT03298685</url>
  </required_header>
  <id_info>
    <org_study_id>38RC17.005</org_study_id>
    <secondary_id>2017-A00062-51</secondary_id>
    <nct_id>NCT03298685</nct_id>
  </id_info>
  <brief_title>SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers</brief_title>
  <acronym>SAFETIM-needs</acronym>
  <official_title>SAFETIM Besoins: Suivi Des Adolescents Des Familles et Des Equipes Pour Une Transition Idéale en Mucoviscidose Etude Des Besoins Adolescents et Parent Avant après Transition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</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>
      prospective multicentric study protocol in french CF center, exploring adolescent avec&#xD;
      parents needs during transition from pediatric CF center to adult CF center&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescent's and parent's needs will be studied, before the transition and their experiences&#xD;
      of transition, in order to propose organizational national recommendations semi structured&#xD;
      interview with adolescents and parents separately, before and after transition.&#xD;
&#xD;
      semi structured interviews will be conducted twice for each (adolescent and parents), the&#xD;
      first in the 6 months before transition and the second in the 6 months after transition.&#xD;
&#xD;
      After their verbatims will be analyzed and the optimal organisation will be determined for&#xD;
      the transition based according to their point of view.&#xD;
&#xD;
      At the end, the data from this study will be matched with data collected in a former study&#xD;
      from care givers practices during transition in the french CF centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify CF adolescents and their parents needs before transition</measure>
    <time_frame>During their systematic appointment at the CF center, patients will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed.</time_frame>
    <description>Qualitative analysis of interviews</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify CF adolescents and their parents experience after transition</measure>
    <time_frame>During their systematic appointment at the CF center, patients will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed.</time_frame>
    <description>Qualitative analysis of interviews</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>What do they need, to feel safe before transition</measure>
    <time_frame>During their systematic appointment at the CF center, patients and parents will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed</time_frame>
    <description>Identify patients and parents needs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Do these needs of CFadolescent and their parents taken into account in the transition procedures</measure>
    <time_frame>During their systematic appointment at the CF center, patients and parents will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed</time_frame>
    <description>Do the procedures take into account the needs of patients and parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Which factors influence quality of transition other than TPE dimension.</measure>
    <time_frame>Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched</time_frame>
    <description>Satisfaction level of Patients and Family After Transition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations</measure>
    <time_frame>comparison between the results with health care practices one year after the last interview will be performed</time_frame>
    <description>Identifying key points of the patient's personalized transition, the timing and personalization of the health care course during the transition</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Cystic Fibrosis</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>CF patient and parents cohort in 3 CF center</arm_group_label>
    <description>All adolescents for whom the transition to the adult center is scheduled within six months and their parent will be interviewed before and after transition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>semi structured interviews for all adolescents and their parent</intervention_name>
    <description>Before and after transition, individual semi structured interviews will be recorded by one person in the same way in all CF center. And every interview will be transcribed by an other person</description>
    <arm_group_label>CF patient and parents cohort in 3 CF center</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        CF adolescent and their parents , for whom the transition to the adult center is scheduled&#xD;
        within six months and witch have freely agreed to participate in the interviews their age&#xD;
        will be between 17 and 23 years old. living followed in one of the 3 CF center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CF adolescent and their parents , for whom the transition to the adult center is&#xD;
             scheduled within six months and witch have freely agreed to participate in the&#xD;
             interviews&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LLERENA catherine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU GA Grenobe France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital, Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversityHospitalGrenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Femme Mère Enfant, HCL</name>
      <address>
        <city>Lyon</city>
        <zip>69322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Hospital of Lyon, HCL</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Bregnballe V, Schiotz PO, Lomborg K. Parenting adolescents with cystic fibrosis: the adolescents' and young adults' perspectives. Patient Prefer Adherence. 2011;5:563-70. doi: 10.2147/PPA.S25870. Epub 2011 Nov 7.</citation>
    <PMID>22114471</PMID>
  </reference>
  <reference>
    <citation>Kreindler JL, Miller VA. Cystic fibrosis: addressing the transition from pediatric to adult-oriented health care. Patient Prefer Adherence. 2013 Dec 11;7:1221-6. doi: 10.2147/PPA.S37710.</citation>
    <PMID>24376344</PMID>
  </reference>
  <reference>
    <citation>Blum RW, Garell D, Hodgman CH, Jorissen TW, Okinow NA, Orr DP, Slap GB. Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J Adolesc Health. 1993 Nov;14(7):570-6. doi: 10.1016/1054-139x(93)90143-d. No abstract available.</citation>
    <PMID>8312295</PMID>
  </reference>
  <reference>
    <citation>Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.</citation>
    <PMID>20040605</PMID>
  </reference>
  <reference>
    <citation>Davis AM, Brown RF, Taylor JL, Epstein RA, McPheeters ML. Transition care for children with special health care needs. Pediatrics. 2014 Nov;134(5):900-8. doi: 10.1542/peds.2014-1909. Epub 2014 Oct 6.</citation>
    <PMID>25287460</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transition</keyword>
  <keyword>care program</keyword>
  <keyword>needs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03298685
org study id: 38RC17.005
secondary id: 2017-A00062-51
nct id: NCT03298685
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
prospective multicentric study protocol in french CF center, exploring adolescent avec
      parents needs during transition from pediatric CF center to adult CF center
Adolescent's and parent's needs will be studied, before the transition and their experiences
      of transition, in order to propose organizational national recommendations semi structured
      interview with adolescents and parents separately, before and after transition.

      semi structured interviews will be conducted twice for each (adolescent and parents), the
      first in the 6 months before transition and the second in the 6 months after transition.

      After their verbatims will be analyzed and the optimal organisation will be determined for
      the transition based according to their point of view.

      At the end, the data from this study will be matched with data collected in a former study
      from care givers practices during transition in the french CF centers.
observational model: Other
time perspective: Prospective
measure: Identify CF adolescents and their parents needs before transition
time frame: During their systematic appointment at the CF center, patients will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed.
description: Qualitative analysis of interviews
measure: Identify CF adolescents and their parents experience after transition
time frame: During their systematic appointment at the CF center, patients will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed.
description: Qualitative analysis of interviews
measure: What do they need, to feel safe before transition
time frame: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year before transition. Interviews will be analyzed after all interviews will have been performed
description: Identify patients and parents needs
measure: Do these needs of CFadolescent and their parents taken into account in the transition procedures
time frame: During their systematic appointment at the CF center, patients and parents will have one individual interview during the year after transition. Interviews will be analyzed after all interviews will have been performed
description: Do the procedures take into account the needs of patients and parents
measure: Which factors influence quality of transition other than TPE dimension.
time frame: Interviews will be analyzed after an average of one year after the last interviews will have been performed, both outcome will be matched
description: Satisfaction level of Patients and Family After Transition
measure: Do the resources implemented by the CRCM teams during the adolescent-adult transition matched with adolescents and parents needs and expectations
time frame: comparison between the results with health care practices one year after the last interview will be performed
description: Identifying key points of the patient's personalized transition, the timing and personalization of the health care course during the transition
arm group label: CF patient and parents cohort in 3 CF center
description: All adolescents for whom the transition to the adult center is scheduled within six months and their parent will be interviewed before and after transition.
intervention type: Other
intervention name: semi structured interviews for all adolescents and their parent
description: Before and after transition, individual semi structured interviews will be recorded by one person in the same way in all CF center. And every interview will be transcribed by an other person
arm group label: CF patient and parents cohort in 3 CF center
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: LLERENA catherine, MD
role: Principal Investigator
affiliation: CHU GA Grenobe France
facility: 
facility: 
facility: 
facility: 
country: France
citation: Bregnballe V, Schiotz PO, Lomborg K. Parenting adolescents with cystic fibrosis: the adolescents' and young adults' perspectives. Patient Prefer Adherence. 2011;5:563-70. doi: 10.2147/PPA.S25870. Epub 2011 Nov 7.
PMID: 22114471
citation: Kreindler JL, Miller VA. Cystic fibrosis: addressing the transition from pediatric to adult-oriented health care. Patient Prefer Adherence. 2013 Dec 11;7:1221-6. doi: 10.2147/PPA.S37710.
PMID: 24376344
citation: Blum RW, Garell D, Hodgman CH, Jorissen TW, Okinow NA, Orr DP, Slap GB. Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J Adolesc Health. 1993 Nov;14(7):570-6. doi: 10.1016/1054-139x(93)90143-d. No abstract available.
PMID: 8312295
citation: Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
PMID: 20040605
citation: Davis AM, Brown RF, Taylor JL, Epstein RA, McPheeters ML. Transition care for children with special health care needs. Pediatrics. 2014 Nov;134(5):900-8. doi: 10.1542/peds.2014-1909. Epub 2014 Oct 6.
PMID: 25287460
responsible party type: Sponsor
mesh term: Cystic Fibrosis
sharing ipd: No