Sickle Cell DiseaseSOCIODREPNCT04793854
Sickle Cell Disease, Neurocognitive Disorders, Social Participation
An observational study of Sickle Cell Disease, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Measure of the Life habits (MHAVIE)
- How many people
- 134 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 19 Sep 2018to 3 Jun 2019
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study concerns patients with sickle cell anemia, followed by physicians in Guadeloupe.
Who may be able to join
- Sickle cell anemia
- Age between 6 and 16 years inccuded, attending the centre of reference for sickle cell disease in Guadeloupe
- Informed consent
- Medical insurance
Who cannot join
- Other sickle cell syndrome other than SS or Sb-thal
- Less than 6 years old or older than 16
- Attending other sickle cell departments
- No medical insurance
Trial locations and contacts
1 site in 1 country.
About this study
This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders.
Read the detailed description
Sickle cell anaemia, which is the most frequent genetic disease in France, requires an early and optimal care to reduce its morbidity and mortality. Children with sickle cell anaemia who are significantly anaemic may present neurological complications including stroke with or without clinical signs. A major risk associated to these strokes is the impairment of the general intellectual ability and learning ability, essentially resulting from neuropsychological disorders affecting intellectual functioning, executive and attentional functions. Although the negative impact of sickle cell anemia on the quality of life of the affected children and adolescents is well documented, no study has been focused on the role played by the neurocognitive disorders on their social participation. The objective of this project is the assessment of the influence of neurocognitive disorders in the social participation of children and adolescent with sickle cell anemia (6 to 16 years old), followed in Guadeloupe. This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders
- Conditions
- Sickle Cell Disease
- Being tested
- Measure of the Life habits (MHAVIE)
- Keywords
- neurocognitive disorders, social participation
- Medical subject headings
- Anemia, Sickle Cell, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of the Life habits (MHAVIE)Other
Also called Measure of Environmental Quality (MQE), semi-guided interviews
Life habits include daily activities and social in 6 groups. Environmental factors include social (9 different subgroups) and physical factors (7 different subgroups).
Personal factors are person related parameters (gender, age, sociocultural ethnic, skills, deficiencies factors,…).
| Study group | Role | What they receive |
|---|---|---|
| Case | Children with sickle cell anemia attending the centre of reference for sickle cell disease in Guadeloupe. Receives: Other: Measure of the Life habits (MHAVIE) | |
| Control | Control children without chronical disease Receives: Other: Measure of the Life habits (MHAVIE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MHAVIE-Children
Assessment of Life Habits-LIFE-H
Measured: Inclusion
MQE
Measure of Environmental Quality (MQE)
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start19 Sep 2018
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Collaborators
- Université des Antilles, LAboratoire ACTES
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793854
- Sponsor's protocol ID
- PAP_RNI_2018/02
- Acronym
- SOCIODREP
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Disease, Neurocognitive Disorders, Social Participation
- ClinicalTrials.gov ID
- NCT04793854
- Acronym / sponsor ID
- SOCIODREP / PAP_RNI_2018/02
- Conditions
- Sickle Cell Disease
- Keywords
- neurocognitive disorders, social participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Collaborators
- Université des Antilles, LAboratoire ACTES
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 11 Mar 2021 (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.
This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders.
Detailed description
Sickle cell anaemia, which is the most frequent genetic disease in France, requires an early and optimal care to reduce its morbidity and mortality. Children with sickle cell anaemia who are significantly anaemic may present neurological complications including stroke with or without clinical signs. A major risk associated to these strokes is the impairment of the general intellectual ability and learning ability, essentially resulting from neuropsychological disorders affecting intellectual functioning, executive and attentional functions. Although the negative impact of sickle cell anemia on the quality of life of the affected children and adolescents is well documented, no study has been focused on the role played by the neurocognitive disorders on their social participation. The objective of this project is the assessment of the influence of neurocognitive disorders in the social participation of children and adolescent with sickle cell anemia (6 to 16 years old), followed in Guadeloupe. This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Measure of the Life habits (MHAVIE)Children with sickle cell anemia attending the centre of reference for sickle cell disease in Guadeloupe. |
| Control | – | Other: Measure of the Life habits (MHAVIE)Control children without chronical disease |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study concerns patients with sickle cell anemia, followed by physicians in Guadeloupe.
Key inclusion criteria (4 listed)
- Sickle cell anemia
- Age between 6 and 16 years inccuded, attending the centre of reference for sickle cell disease in Guadeloupe
- Informed consent
- Medical insurance
Key exclusion criteria (4 listed)
- Other sickle cell syndrome other than SS or Sb-thal
- Less than 6 years old or older than 16
- Attending other sickle cell departments
- No medical insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of the Life habits (MHAVIE)Also: Measure of Environmental Quality (MQE), semi-guided interviewsLife habits include daily activities and social in 6 groups. Environmental factors include social (9 different subgroups) and physical factors (7 different subgroups). Personal factors are person related parameters (gender, age, sociocultural ethnic, skills, deficiencies factors,…). | Other | Case, Control |
Primary outcome
MHAVIE-Children
Time frame: Inclusion
Assessment of Life Habits-LIFE-H
MQE
Time frame: Inclusion
Measure of Environmental Quality (MQE)
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 11 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Disease
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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 Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 4 inclusion and 4 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 11 Mar 2021. 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 Guadeloupe. 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?
MHAVIE-Children (time frame: Inclusion). The study lists 2 primary outcomes in all. 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 11 Mar 2021.