Sickle Cell DiseaseSEXODREPNCT03235011
Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.
An observational study of Sickle Cell Disease, run by Adele CARLIER-GONOD at 1 site in France.
Trial summary
Evaluation of knowledge about contraception in sickle cell adolescents. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2017to 31 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.
Who may be able to join
- Patients with sickle cell disease followed at the CHIC
- Aged 14 to 19
- Both sexes
Who cannot join
- Neurological disorders that can impede understanding of the questionnaire.
- Refusal to participate.
- Not affiliated to social security.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal de Créteil
Créteil, Creteil, 77500
About this study
Official title: Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.
Evaluation of knowledge about contraception in sickle cell adolescents.
Read the 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.
- Conditions
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Score value of the questionnaire on general knowledge on contraception
questionnaire on general knowledge on contraception rated by 4 questions
Measured: at inclusion
Secondary outcomes (7)
Score value of the questionnaire on specific knowledge on the transmission of the disease
Measured: at inclusion
Score value of the questionnaire on the transmission of the disease knowledge
Measured: at inclusion
Score value of the questionnaire on specific knowledge about the impact of sickle cell disease on the course of puberty
Measured: at inclusion
Score value of the questionnaire onspecific knowledge about the impact of sickle cell disease on the course of sexuality
Measured: at inclusion
age of the patient with sickle cell disease
Measured: at inclusion
gender of the patient with sickle cell disease
Measured: at inclusion
number of hospitalizations of the patient with sickle cell disease
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start10 Mar 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adele CARLIER-GONOD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adele CARLIER-GONOD, Centre Hospitalier Intercommunal Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235011
- Sponsor's protocol ID
- SEXODREP
- Acronym
- SEXODREP
- Status last verified
- Feb 2019
- First submitted
- 27 Jul 2017
- Last updated
- 6 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Knowledge and Practices About Contraception, Sexuality and Transmission Among Adolescents With Sickle Cell Disease.
- ClinicalTrials.gov ID
- NCT03235011
- Acronym / sponsor ID
- SEXODREP / SEXODREP
- Conditions
- Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Adele CARLIER-GONODUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.
Key inclusion criteria (3 listed)
- Patients with sickle cell disease followed at the CHIC
- Aged 14 to 19
- Both sexes
Key exclusion criteria (3 listed)
- Neurological disorders that can impede understanding of the questionnaire.
- Refusal to participate.
- Not affiliated to social security.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score value of the questionnaire on general knowledge on contraception
Time frame: at inclusion
questionnaire on general knowledge on contraception rated by 4 questions
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Adele CARLIER-GONOD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score value of the questionnaire on general knowledge on contraception (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.