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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235011
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Adele CARLIER-GONOD, Centre Hospitalier Intercommunal Creteil

Tracking Information
First Submitted Date July 27, 2017
First Posted Date August 1, 2017
Last Update Posted Date February 6, 2019
Actual Study Start Date March 10, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2017)		 Score value of the questionnaire on general knowledge on contraception [ Time Frame: at inclusion ]
questionnaire on general knowledge on contraception rated by 4 questions
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 27, 2017)
  • Score value of the questionnaire on specific knowledge on the transmission of the disease [ Time Frame: at inclusion ]
  • Score value of the questionnaire on the transmission of the disease knowledge [ Time Frame: at inclusion ]
  • Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty [ Time Frame: at inclusion ]
  • Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality [ Time Frame: at inclusion ]
  • age of the patient with sickle cell disease [ Time Frame: at inclusion ]
  • gender of the patient with sickle cell disease [ Time Frame: at inclusion ]
  • number of hospitalizations of the patient with sickle cell disease [ Time Frame: at inclusion ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.
Official Title Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.
Brief Summary Evaluation of knowledge about contraception in sickle cell adolescents.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.
Condition Sickle Cell Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 5, 2019)		 99
Original Estimated Enrollment
 (submitted: July 27, 2017)		 100
Actual Study Completion Date January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03235011
Other Study ID Numbers SEXODREP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Adele CARLIER-GONOD, Centre Hospitalier Intercommunal Creteil
Original Responsible Party Same as current
Current Study Sponsor Adele CARLIER-GONOD
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date February 2019