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NCT Number: NCT04413539

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

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.

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Key information

Conditions

Sickle-cell Disease (SCD) Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de références syndromes drépanocytaires majeurs thalassémie et autres maladies rares du globule rouge et de l'érythropoïése

Créteil, France

About this study

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:

  • socio-demographic questions to establish a respondent profile
  • health status of the respondent to establish the severity of the disease
  • education, professional life, material and economic situation
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Argo Sante

Other

Collaborators

  • Filière de santé maladies rares MCGRE
  • Fédération des malades drépanocytaires et thalassémiques SOS Globi
  • Genetix Biotherapeutics Inc.

Registry information

Acronym: DREPAtient

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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