<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/NCT03301376</url>
  </required_header>
  <id_info>
    <org_study_id>2016-51</org_study_id>
    <nct_id>NCT03301376</nct_id>
  </id_info>
  <brief_title>Occupational Integration of Adults With Severe Haemophilia in France: a Study Based on the FranceCoag Cohort</brief_title>
  <acronym>INTHEMO</acronym>
  <official_title>INTHEMO: Occupational Integration of Adults With Severe Haemophilia in France: a Study Based on the FranceCoag Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      Severe haemophilia and subsequent arthropathy result in joint pain, disability and impaired&#xD;
      health-related quality of life. Improvements in haemophilia care over the last decades might&#xD;
      lead to expectation of a near-normal quality of life for adults with haemophilia. However,&#xD;
      little is known about the impact of haemophilia and its treatment on social functioning. A&#xD;
      study based on a national US cohort of 141 young men (18-34 y.o.) showed that, compared to&#xD;
      the general US population, this cohort experienced social burdens such as unemployment and&#xD;
      lower high-school graduation rates. Another study conducted in the framework of the HERO&#xD;
      (Haemophilia Experiences, Results and Opportunities) international initiative showed that a&#xD;
      majority of the 230 young adults aged 18-30 years (including 16 French participants) were&#xD;
      employed at least part-time (62%) and most of them reported that haemophilia has had a&#xD;
      negative impact on employment (76%) which was reported as moderate or very large by 47% of&#xD;
      the participants. The replicability of these results could be limited by the specific&#xD;
      socio-economic national context. In France, a survey was conducted in 2008 to assess quality&#xD;
      of life and its determinants in children, adolescents and adults with moderate and severe&#xD;
      haemophilia. Descriptive results on the socio-economic characteristics of the included adults&#xD;
      showed that 51.3% of them had access to higher education (which was higher than the observed&#xD;
      rate in the French general population in 2005, i.e. 32.5%), and that 52.1% were employed&#xD;
      among whom 44.3% had an at-risk activity. In spite of these results which were presented in a&#xD;
      descriptive report by the InVS (Institut de veille sanitaire - French Institute for Public&#xD;
      Health Surveillance), some limitations could be discussed:&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principal objective of the present project is to assess occupational issues in an&#xD;
      exhaustive national cohort of persons with severe haemophilia compared to the national&#xD;
      population in order to describe the impact of severe haemophilia on the occupational&#xD;
      integration.&#xD;
&#xD;
      Detailed objectives are mentioned hereinbelow:&#xD;
&#xD;
        1. To assess occupational issues in adults with severe haemophilia in France&#xD;
&#xD;
        2. To assess the impact of the changes of the context of life over the last decades in the&#xD;
           new generation of adults with severe haemophilia in France&#xD;
&#xD;
        3. To compare occupational outcomes between adults with severe haemophilia and the general&#xD;
           population in France&#xD;
&#xD;
        4. To identify individual characteristics (socio-demographics, clinical and&#xD;
           psycho-behavioural) associated with occupational issues in adults with severe&#xD;
           haemophilia in France&#xD;
&#xD;
        5. To compare occupational issues between adults with severe haemophilia and adults with&#xD;
           others severe chronic childhood diseases in France to identify common and&#xD;
           haemophilia-specific issues&#xD;
&#xD;
      Material and methods:&#xD;
&#xD;
      All adults (18-65 y.o.) participating in the FranceCoag cohort, which includes more than&#xD;
      1,500 French adults with severe haemophilia followed-up in 34 Haemophilia Treatment Centres,&#xD;
      will be invited to participate in the study. These adults will be identified through the&#xD;
      database of the FranceCoag cohort, and will be invited to participate through the post by the&#xD;
      physician who follows them up in the Haemophilia Treatment Centre. If they agree to&#xD;
      participate, they will be asked to fill a self-administered questionnaire in. This&#xD;
      questionnaire will include items focusing on the following outcomes:&#xD;
&#xD;
        -  occupational outcomes:&#xD;
&#xD;
             -  access to higher education and high-school graduation,&#xD;
&#xD;
             -  age at the start of working life,&#xD;
&#xD;
             -  degree of employment (unemployment / part-time employment / full-time employment),&#xD;
&#xD;
             -  sheltered employment,&#xD;
&#xD;
             -  job security (temporary / permanent contract / self-employment),&#xD;
&#xD;
             -  type of job (using the International Standard Classification of Occupations)&#xD;
&#xD;
        -  socio-demographic outcomes:&#xD;
&#xD;
             -  age&#xD;
&#xD;
             -  living with a partner&#xD;
&#xD;
             -  having dependent children&#xD;
&#xD;
        -  psycho-behavioural outcomes:&#xD;
&#xD;
             -  depressive symptomatology (using the Center for Epidemiologic Studies Depression&#xD;
                (CES-D) scale)&#xD;
&#xD;
             -  quality of life (using the generic scale 36-Item Short Form Survey (SF-12) and the&#xD;
                haemophilia-specific scale Haem-A-QoL)&#xD;
&#xD;
             -  anxiety (using the Strate-Trait Anxiety Inventory (STAI) scale)&#xD;
&#xD;
             -  coping strategies (using the BriefCOPE)&#xD;
&#xD;
             -  perceived impact of haemophilia on employment&#xD;
&#xD;
             -  participating in therapeutic education sessions&#xD;
&#xD;
             -  member of the Association française des hémophiles (AFH)&#xD;
&#xD;
      Clinical outcomes will be recorded via the FranceCoag cohort database (type of haemophilia,&#xD;
      treatment, presence of an inhibitor, comorbidities as HIV and HCV infections).&#xD;
&#xD;
      Occupational outcomes of the participants will be described, and compared to the French&#xD;
      national population. Expected distributions of the outcomes will be established by using data&#xD;
      from the French National Institute for Statistics and Economic Studies. Observed and expected&#xD;
      distributions will be compared. The modulating role of individual characteristics (including&#xD;
      the period of birth, the presence of an inhibitor, comorbidities as HIV and HCV infections)&#xD;
      in occupational issues will be assessed.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      The results of this project will establish an updated picture of the occupational situation&#xD;
      of French adults with severe haemophilia. By comparing the evolution of the occupational&#xD;
      situation among them with the evolution in adults from the general population, the&#xD;
      investigators will be able to assess the possibly different impact of the changes of the&#xD;
      socio-economic context on the occupational situation of adults with severe haemophilia. The&#xD;
      results will also establish a new picture of the occupational situation for the new&#xD;
      generation of adults who was not concerned by the survey carried out about ten years ago.&#xD;
      This sub-group is of particular interest as the impact of the disease on their life might&#xD;
      have been different (major therapeutic progresses, no exposition to transfusion-transmitted&#xD;
      infections).&#xD;
&#xD;
      Via the French haemophilia society (AFH) which is a partner of the present project, the&#xD;
      results from the objectives 1 to 4 will be used for the education, training and awareness of&#xD;
      patient resources, for the development of therapeutic patient education sessions focused on&#xD;
      occupational issues, and for the drawing up of a brochure intended for patients.&#xD;
&#xD;
      Survivors of childhood leukemia from the French LEA cohort who present a higher rate of&#xD;
      employment than the general population, but a lower access to a steady job could be an&#xD;
      interesting comparative group for the fifth objective. As numerous actions are proposed to&#xD;
      facilitate the occupational integration of survivors of cancer, the identification of the&#xD;
      haemophilia-specific difficulties could help the decisions-makers to allocate means according&#xD;
      to the specific needs of the persons with haemophilia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2018</start_date>
  <completion_date type="Actual">May 27, 2020</completion_date>
  <primary_completion_date type="Actual">May 27, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Degree of employment</measure>
    <time_frame>one day</time_frame>
    <description>unemployment / part-time employment / full-time employment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Access to higher education and high-school graduation</measure>
    <time_frame>one day</time_frame>
    <description>Specific item of the patient questionnaire (yes(type)/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age at the start of working life</measure>
    <time_frame>one day</time_frame>
    <description>Specific item of the patient questionnaire (age(years))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheltered employment</measure>
    <time_frame>one day</time_frame>
    <description>Specific item of the patient questionnaire (yes(type)/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Job security</measure>
    <time_frame>one day</time_frame>
    <description>Specific item of the patient questionnaire (temporary / permanent contract / self-employment)</description>
  </secondary_outcome>
  <enrollment type="Actual">590</enrollment>
  <condition>Severe Haemophilia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        adults with severe haemophilia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with severe haemophilia&#xD;
&#xD;
          -  Patients aged from 18 to 65 years old&#xD;
&#xD;
          -  Patients enrolled in the FranceCoag national cohort&#xD;
&#xD;
          -  Patients affiliated to the French social security system&#xD;
&#xD;
          -  Non opposition to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with moderate or minor haemophilia&#xD;
&#xD;
          -  Patients under the age of 18 or over the age of 65&#xD;
&#xD;
          -  Patients with comprehension problems&#xD;
&#xD;
          -  Patients unable to read or to write&#xD;
&#xD;
          -  Vulnerable patients&#xD;
&#xD;
          -  Opposition to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle DESALBRES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital de la Timone Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</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/NCT03301376
org study id: 2016-51
nct id: NCT03301376
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe haemophilia and subsequent arthropathy result in joint pain, disability and impaired
      health-related quality of life. Improvements in haemophilia care over the last decades might
      lead to expectation of a near-normal quality of life for adults with haemophilia. However,
      little is known about the impact of haemophilia and its treatment on social functioning. A
      study based on a national US cohort of 141 young men (18-34 y.o.) showed that, compared to
      the general US population, this cohort experienced social burdens such as unemployment and
      lower high-school graduation rates. Another study conducted in the framework of the HERO
      (Haemophilia Experiences, Results and Opportunities) international initiative showed that a
      majority of the 230 young adults aged 18-30 years (including 16 French participants) were
      employed at least part-time (62%) and most of them reported that haemophilia has had a
      negative impact on employment (76%) which was reported as moderate or very large by 47% of
      the participants. The replicability of these results could be limited by the specific
      socio-economic national context. In France, a survey was conducted in 2008 to assess quality
      of life and its determinants in children, adolescents and adults with moderate and severe
      haemophilia. Descriptive results on the socio-economic characteristics of the included adults
      showed that 51.3% of them had access to higher education (which was higher than the observed
      rate in the French general population in 2005, i.e. 32.5%), and that 52.1% were employed
      among whom 44.3% had an at-risk activity. In spite of these results which were presented in a
      descriptive report by the InVS (Institut de veille sanitaire - French Institute for Public
      Health Surveillance), some limitations could be discussed:
The principal objective of the present project is to assess occupational issues in an
      exhaustive national cohort of persons with severe haemophilia compared to the national
      population in order to describe the impact of severe haemophilia on the occupational
      integration.

      Detailed objectives are mentioned hereinbelow:

        1. To assess occupational issues in adults with severe haemophilia in France

        2. To assess the impact of the changes of the context of life over the last decades in the
           new generation of adults with severe haemophilia in France

        3. To compare occupational outcomes between adults with severe haemophilia and the general
           population in France

        4. To identify individual characteristics (socio-demographics, clinical and
           psycho-behavioural) associated with occupational issues in adults with severe
           haemophilia in France

        5. To compare occupational issues between adults with severe haemophilia and adults with
           others severe chronic childhood diseases in France to identify common and
           haemophilia-specific issues

      Material and methods:

      All adults (18-65 y.o.) participating in the FranceCoag cohort, which includes more than
      1,500 French adults with severe haemophilia followed-up in 34 Haemophilia Treatment Centres,
      will be invited to participate in the study. These adults will be identified through the
      database of the FranceCoag cohort, and will be invited to participate through the post by the
      physician who follows them up in the Haemophilia Treatment Centre. If they agree to
      participate, they will be asked to fill a self-administered questionnaire in. This
      questionnaire will include items focusing on the following outcomes:

        -  occupational outcomes:

             -  access to higher education and high-school graduation,

             -  age at the start of working life,

             -  degree of employment (unemployment / part-time employment / full-time employment),

             -  sheltered employment,

             -  job security (temporary / permanent contract / self-employment),

             -  type of job (using the International Standard Classification of Occupations)

        -  socio-demographic outcomes:

             -  age

             -  living with a partner

             -  having dependent children

        -  psycho-behavioural outcomes:

             -  depressive symptomatology (using the Center for Epidemiologic Studies Depression
                (CES-D) scale)

             -  quality of life (using the generic scale 36-Item Short Form Survey (SF-12) and the
                haemophilia-specific scale Haem-A-QoL)

             -  anxiety (using the Strate-Trait Anxiety Inventory (STAI) scale)

             -  coping strategies (using the BriefCOPE)

             -  perceived impact of haemophilia on employment

             -  participating in therapeutic education sessions

             -  member of the Association française des hémophiles (AFH)

      Clinical outcomes will be recorded via the FranceCoag cohort database (type of haemophilia,
      treatment, presence of an inhibitor, comorbidities as HIV and HCV infections).

      Occupational outcomes of the participants will be described, and compared to the French
      national population. Expected distributions of the outcomes will be established by using data
      from the French National Institute for Statistics and Economic Studies. Observed and expected
      distributions will be compared. The modulating role of individual characteristics (including
      the period of birth, the presence of an inhibitor, comorbidities as HIV and HCV infections)
      in occupational issues will be assessed.

      Expected results:

      The results of this project will establish an updated picture of the occupational situation
      of French adults with severe haemophilia. By comparing the evolution of the occupational
      situation among them with the evolution in adults from the general population, the
      investigators will be able to assess the possibly different impact of the changes of the
      socio-economic context on the occupational situation of adults with severe haemophilia. The
      results will also establish a new picture of the occupational situation for the new
      generation of adults who was not concerned by the survey carried out about ten years ago.
      This sub-group is of particular interest as the impact of the disease on their life might
      have been different (major therapeutic progresses, no exposition to transfusion-transmitted
      infections).

      Via the French haemophilia society (AFH) which is a partner of the present project, the
      results from the objectives 1 to 4 will be used for the education, training and awareness of
      patient resources, for the development of therapeutic patient education sessions focused on
      occupational issues, and for the drawing up of a brochure intended for patients.

      Survivors of childhood leukemia from the French LEA cohort who present a higher rate of
      employment than the general population, but a lower access to a steady job could be an
      interesting comparative group for the fifth objective. As numerous actions are proposed to
      facilitate the occupational integration of survivors of cancer, the identification of the
      haemophilia-specific difficulties could help the decisions-makers to allocate means according
      to the specific needs of the persons with haemophilia.
observational model: Cohort
time perspective: Prospective
measure: Degree of employment
time frame: one day
description: unemployment / part-time employment / full-time employment
measure: Access to higher education and high-school graduation
time frame: one day
description: Specific item of the patient questionnaire (yes(type)/no)
measure: Age at the start of working life
time frame: one day
description: Specific item of the patient questionnaire (age(years))
measure: Sheltered employment
time frame: one day
description: Specific item of the patient questionnaire (yes(type)/no)
measure: Job security
time frame: one day
description: Specific item of the patient questionnaire (temporary / permanent contract / self-employment)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Urielle DESALBRES
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Hemophilia A