Evaluation of Knowledge Among Adolescents With Sickle Cel... | NCT03235011

Studies
Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.

NCT03235011

Sponsor

Adele CARLIER-GONOD

Status

Completed

Last Update Posted

Feb 6, 2019Actual

Enrollment

99Actual

Phase

Not provided

Conditions

Sickle Cell Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2017Actual

Primary Completion Date

Jan 31, 2018Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

Jul 27, 2017

First Submission Date that Met QC Criteria

Jul 27, 2017

First Posted Date

Aug 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2019

Last Update Posted Date

Feb 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score value of the questionnaire on general knowledge on contraception	questionnaire on general knowledge on contraception rated by 4 questions	at inclusion

Secondary Outcomes

Measure	Description	Time Frame
Score value of the questionnaire on specific knowledge on the transmission of the disease		at inclusion
Score value of the questionnaire on the transmission of the disease knowledge		at inclusion

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Intercommunal de Créteil		Créteil	Creteil	77500	France

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided