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

NCT ID: NCT04413539

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1088 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-02

Study Completion Date

2021-04-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sickle-cell Disease (SCD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Filière de santé maladies rares MCGRE

UNKNOWN

Sponsor Role collaborator

Fédération des malades drépanocytaires et thalassémiques SOS Globi

UNKNOWN

Sponsor Role collaborator

Genetix Biotherapeutics Inc.

INDUSTRY

Sponsor Role collaborator

Argo Sante

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic Galacteros, MD,PhD,Prof.

Role: PRINCIPAL_INVESTIGATOR

Red Cell genetic diseases unity, Henri Mondor Hospital, Paris

Locations

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

Créteil, , France

Site Status

Countries

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France

References

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Crosby LE, Joffe NE, Irwin MK, Strong H, Peugh J, Shook L, Kalinyak KA, Mitchell MJ. School Performance and Disease Interference in Adolescents with Sickle Cell Disease. Phys Disabil. 2015;34(1):14-30. doi: 10.14434/pders.v34i1.13918.

Reference Type BACKGROUND
PMID: 27547816 (View on PubMed)

Dos Santos JP, Gomes Neto M. Sociodemographic aspects and quality of life of patients with sickle cell anemia. Rev Bras Hematol Hemoter. 2013;35(4):242-5. doi: 10.5581/1516-8484.20130093.

Reference Type BACKGROUND
PMID: 24106440 (View on PubMed)

Gardner K, Douiri A, Drasar E, Allman M, Mwirigi A, Awogbade M, Thein SL. Survival in adults with sickle cell disease in a high-income setting. Blood. 2016 Sep 8;128(10):1436-8. doi: 10.1182/blood-2016-05-716910. Epub 2016 Jul 20. No abstract available.

Reference Type BACKGROUND
PMID: 27439910 (View on PubMed)

Habibi A, Arlet JB, Stankovic K, Gellen-Dautremer J, Ribeil JA, Bartolucci P, Lionnet F; centre de reference maladies rares << syndromes drepanocytaires majeurs >>. [French guidelines for the management of adult sickle cell disease: 2015 update]. Rev Med Interne. 2015 May 11;36(5 Suppl 1):5S3-84. doi: 10.1016/S0248-8663(15)60002-9. French.

Reference Type BACKGROUND
PMID: 26007619 (View on PubMed)

Chapelon E, Garabedian M, Brousse V, Souberbielle JC, Bresson JL, de Montalembert M. Osteopenia and vitamin D deficiency in children with sickle cell disease. Eur J Haematol. 2009 Dec 1;83(6):572-8. doi: 10.1111/j.1600-0609.2009.01333.x. Epub 2009 Aug 13.

Reference Type BACKGROUND
PMID: 19682065 (View on PubMed)

Godeau B, Noel V, Habibi A, Schaeffer A, Bachir D, Galacteros F. [Sickle cell disease in adults: which emergency care by the internists?]. Rev Med Interne. 2001 May;22(5):440-51. doi: 10.1016/s0248-8663(01)00369-1. French.

Reference Type BACKGROUND
PMID: 11402515 (View on PubMed)

LINDENBAUM J, KLIPSTEIN FA. FOLIC ACID DEFICIENCY IN SICKLE-CELL ANEMIA. N Engl J Med. 1963 Oct 24;269:875-82. doi: 10.1056/NEJM196310242691701. No abstract available.

Reference Type BACKGROUND
PMID: 14050985 (View on PubMed)

Noll RB, Vannatta K, Koontz K, Kalinyak K, Bukowski WM, Davies WH. Peer relationships and emotional well-being of youngsters with sickle cell disease. Child Dev. 1996 Apr;67(2):423-36. doi: 10.1111/j.1467-8624.1996.tb01743.x.

Reference Type BACKGROUND
PMID: 8625722 (View on PubMed)

Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.

Reference Type BACKGROUND
PMID: 21131035 (View on PubMed)

Salih KMA. The impact of sickle cell anemia on the quality of life of sicklers at school age. J Family Med Prim Care. 2019 Feb;8(2):468-471. doi: 10.4103/jfmpc.jfmpc_444_18.

Reference Type BACKGROUND
PMID: 30984656 (View on PubMed)

Sehlo MG, Kamfar HZ. Depression and quality of life in children with sickle cell disease: the effect of social support. BMC Psychiatry. 2015 Apr 11;15:78. doi: 10.1186/s12888-015-0461-6.

Reference Type BACKGROUND
PMID: 25880537 (View on PubMed)

Related Links

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Other Identifiers

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2020-A00729-30

Identifier Type: -

Identifier Source: org_study_id

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