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Evaluation of Knowledge Among Adolescents With Sickle Cell Disease. (SEXODREP)

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ClinicalTrials.gov Identifier: NCT03235011
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Adele CARLIER-GONOD, Centre Hospitalier Intercommunal Creteil

Brief Summary:
Evaluation of knowledge about contraception in sickle cell adolescents.

Condition or disease
Sickle Cell Disease

Detailed Description:

Sickle cell teenagers receive regular hospital medical care.

Adolescence is the time when the pathophysiology of the disease is re-explained and when questions around puberty (possibly delayed), sexuality and contraception are discussed.

Sickle cell disease, like any chronic disease, can have repercussion on the development and behavior of young patients.

Knowledge and understanding of young patients with sickle cell disease around these issues may be insufficient.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control




Primary Outcome Measures :
  1. Score value of the questionnaire on general knowledge on contraception [ Time Frame: at inclusion ]
    questionnaire on general knowledge on contraception rated by 4 questions


Secondary Outcome Measures :
  1. Score value of the questionnaire on specific knowledge on the transmission of the disease [ Time Frame: at inclusion ]
  2. Score value of the questionnaire on the transmission of the disease knowledge [ Time Frame: at inclusion ]
  3. Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty [ Time Frame: at inclusion ]
  4. Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality [ Time Frame: at inclusion ]
  5. age of the patient with sickle cell disease [ Time Frame: at inclusion ]
  6. gender of the patient with sickle cell disease [ Time Frame: at inclusion ]
  7. number of hospitalizations of the patient with sickle cell disease [ Time Frame: at inclusion ]


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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.
Criteria

Inclusion Criteria:

  • Patients with sickle cell disease followed at the CHIC
  • Aged 14 to 19
  • Both sexes

Exclusion Criteria:

  • Neurological disorders that can impede understanding of the questionnaire.
  • Refusal to participate.
  • Not affiliated to social security.

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): NCT03235011


Contacts
Contact: Adele Carlier-Gonod, MD 01 45 17 53 47 Adele.Carlier-Gonod@chicreteil.fr
Contact: Sofia KARA, CRA 0145175000poste8682 sofia.kara@chicreteil.fr

Locations
France
Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, Creteil, France, 77500
Contact: Adele Carlier-Gonod, MD    01 45 17 53 47    Adele.Carlier-Gonod@chicreteil.fr   
Contact: Sofia Kara, CRA    0145175000 poste8682    sofia.kara@chicreteil.fr   
Sponsors and Collaborators
Adele CARLIER-GONOD

Responsible Party: Adele CARLIER-GONOD, Peadiatrician, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03235011     History of Changes
Other Study ID Numbers: SEXODREP
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn