Clinical trial NCT04793854: Sickle Cell Disease, Neurocognitive Disorders, Social Participation
Official title: Sickle Cell Disease, Neurocognitive Disorders, Social Participation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: neurocognitive disorders
social participation
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
Collaborators: name: Université des Antilles, LAboratoire ACTES
First posted: 2021-03-11
Enrollment: 134
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns patients with sickle cell anemia, followed by physicians in Guadeloupe.

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: MHAVIE-Children
timeFrame: Inclusion
measure: MQE
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU de la Guadeloupe
state: France
Study officials:
References: