Sickle-cell Disease (SCD) Clinical Trial
— DREPAtientOfficial 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
| NCT number | NCT04413539 |
| Other study ID # | 2020-A00729-30 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2, 2020 |
| Est. completion date | April 27, 2021 |
| Verified date | July 2021 |
| Source | Argo Sante |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1088 |
| Est. completion date | April 27, 2021 |
| Est. primary completion date | April 27, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre de références syndromes drépanocytaires majeurs thalassémie et autres maladies rares du globule rouge et de l'érythropoïése | Créteil |
| Lead Sponsor | Collaborator |
|---|---|
| Argo Sante | bluebird bio, Fédération des malades drépanocytaires et thalassémiques SOS Globi, Filière de santé maladies rares MCGRE |
France,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Godeau B, Noël V, Habibi A, Schaeffer A, Bachir D, Galactéros F. [Sickle cell disease in adults: which emergency care by the internists?]. Rev Med Interne. 2001 May;22(5):440-51. Review. French. — View Citation
Habibi A, Arlet JB, Stankovic K, Gellen-Dautremer J, Ribeil JA, Bartolucci P, Lionnet F; centre de référence maladies rares " syndromes drépanocytaires 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. — View Citation
LINDENBAUM J, KLIPSTEIN FA. FOLIC ACID DEFICIENCY IN SICKLE-CELL ANEMIA. N Engl J Med. 1963 Oct 24;269:875-82. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Measure of mutual impact of health status on patients educational and socio-professional life course. | Once at enrollment | |
| Secondary | - 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 | 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 |