NCT03235011

Brief Summary

Evaluation of knowledge about contraception in sickle cell adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

July 27, 2017

Last Update Submit

February 5, 2019

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • Score value of the questionnaire on general knowledge on contraception

    questionnaire on general knowledge on contraception rated by 4 questions

    at inclusion

Secondary Outcomes (7)

  • 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

  • Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty

    at inclusion

  • Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality

    at inclusion

  • age of the patient with sickle cell disease

    at inclusion

  • +2 more secondary outcomes

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, Creteil, 77500, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Peadiatrician

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

March 10, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

FR(1)