Sickle Cell Disease, Neurocognitive Disorders, Social Participation

NCT ID: NCT04793854

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2019-06-03

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

Conditions

Sickle Cell Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case

Children with sickle cell anemia attending the centre of reference for sickle cell disease in Guadeloupe.

Measure of the Life habits (MHAVIE)

Intervention Type: OTHER

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,…).

Control

Control children without chronical disease

Measure of the Life habits (MHAVIE)

Intervention Type: OTHER

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,…).

Interventions

Measure of the Life habits (MHAVIE)

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,…).

Intervention Type: OTHER

Other Intervention Names

Measure of Environmental Quality (MQE); semi-guided interviews

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université des Antilles, LAboratoire ACTES

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de la Guadeloupe

Pointe-à-Pitre, France, Guadeloupe

Countries

Guadeloupe

Other Identifiers

PAP_RNI_2018/02

Identifier Type: -

Identifier Source: org_study_id