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)

July 20, 2021 updated by: Argo Sante

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1088

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults or parents of minor children with SCD living in France.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- 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)
Once at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argo Sante

Collaborators

Filière de santé maladies rares MCGRE
Fédération des malades drépanocytaires et thalassémiques SOS Globi
bluebird bio

Investigators

  • Principal Investigator: Frederic Galacteros, MD,PhD,Prof., Red Cell genetic diseases unity, Henri Mondor Hospital, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2020

Primary Completion (Actual)

April 27, 2021

Study Completion (Actual)

April 27, 2021

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00729-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sickle-cell Disease (SCD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe