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Evaluation of Impact of Disease on Quality of Life, Education and Socio-professional Integration of Adults and Parents of Children Living With Sickle- Cell Disease in France (DREPAtient)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04413539
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : July 21, 2021
Sponsor:
Collaborators:
Filière de santé maladies rares MCGRE
Fédération des malades drépanocytaires et thalassémiques SOS Globi
bluebird bio
Information provided by (Responsible Party):
Argo Sante

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Sickle cell disease (SCD) is the most common genetic disease in France. Its consequences on patient's life-course and quality of life need to be precisely identified among French patients and their family to be able to improve patients care according to their specific needs.

The aim of the study is to accurately describe the impact of SCD on quality of life of patients living in France, or their family (for minor patients). The consequences of the disease on professional life, education and material condition of patients or their parents will be described by the patients themselves.


Condition or disease
Sickle-cell Disease (SCD)

Detailed Description:

This is a retrospective study. Patients or parents of minor patients living in France and suffering from SCD will be informed about the study and enrolled during their usual follow-up, or by patients' associations. They will be asked to answer an anonymous survey online relating to their whole life-course with SCD and exploring different aspects of the consequences of the disease on their life. It contains 4 different sections:

  1. socio-demographic questions to establish a respondent profile
  2. health status of the respondent to establish the severity of the disease
  3. education, professional life, material and economic situation
  4. quality of life through MOS SF-36 questionnaire This is a one-shot survey, which will take approximatively 20 to 30 minutes to answer by the respondent.
Study Design
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Study Type : Observational
Actual Enrollment : 1088 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of Impact of Disease on Quality of Life, Education and Socio-professional Integration of Adults and Parents of Children Living With Sickle- Cell Disease in France
Actual Study Start Date : June 2, 2020
Actual Primary Completion Date : April 27, 2021
Actual Study Completion Date : April 27, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Describe the disease impact on quality of life through description of professional life, education and material condition of patients, or their parents (for minor patients), suffering from sickle-cell disease and living in France. [ Time Frame: Once at enrollment ]
    Measure of mutual impact of health status on patients educational and socio-professional life course.


Secondary Outcome Measures :
  1. - Study the factors of heterogeneity of patients' profiles - Explore the causal relation between health status and employment conditions, education, material and economic situation - Assess the patients' needs in care and socio-economic support [ Time Frame: Once at enrollment ]

    The perceived impact of disease on education will be confirmed by:

    • Type of education adjustment introduced
    • The level and the cause of leaving full-time education
    • The intensity of school absences
    • The feeling of discrimination on school time

    The impact of disease on professional life will be measured by:

    • The professional status
    • The sick leaves
    • The feeling of discrimination at work
    • The compatibility of work conditions with the disease

    The impact of disease on material and economic situation will be assessed by:

    • The income level
    • The patient cost sharing
    • The remaining balance
    • The recognition of handicap
    • The recognition of disability

    The quality of life score of respondents:

    - Medical outcome study short form 36 item health survey (MOS SF-36)



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults or parents of minor children with SCD living in France.
Criteria

Inclusion Criteria:

  • 18 years or older
  • Diagnosed with SCD or parent of a minor child diagnosed with SCD
  • Able to speak and understand French
  • Willing to participate to the study

Exclusion Criteria:

  • Person having serious difficulties to read or speak French, unable to answer the questions
  • Person suffering from other chronic disease which could bias the representation they have about SCD
  • Patient cured with a bone marrow transplant
  • Patient with mental disorder preventing the patient to understand the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413539


Locations
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France
Centre de références syndromes drépanocytaires majeurs thalassémie et autres maladies rares du globule rouge et de l'érythropoïése
Créteil, France
Sponsors and Collaborators
Argo Sante
Filière de santé maladies rares MCGRE
Fédération des malades drépanocytaires et thalassémiques SOS Globi
bluebird bio
Investigators
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Principal Investigator: Frederic Galacteros, MD,PhD,Prof. Red Cell genetic diseases unity, Henri Mondor Hospital, Paris
More Information
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Additional Information:

Publications:

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Responsible Party: Argo Sante
ClinicalTrials.gov Identifier: NCT04413539    
Other Study ID Numbers: 2020-A00729-30
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Argo Sante:
Sickle-cell disease
quality of life
education
socio-professional integration
france
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn