Sickle Cell Disease, Neurocognitive Disorders, Social Participation (SOCIODREP)

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 Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: Measure of the Life habits (MHAVIE)

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 Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Guadeloupe
  • France
    • Pointe-à-Pitre, France, Guadeloupe, 97139
      • CHU de la Guadeloupe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study concerns patients with sickle cell anemia, followed by physicians in Guadeloupe.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Children with sickle cell anemia attending the centre of reference for sickle cell disease in Guadeloupe.	Other: 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,…).; Other Names: Measure of Environmental Quality (MQE); semi-guided interviews
Control; Control children without chronical disease	Other: 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,…).; Other Names: Measure of Environmental Quality (MQE); semi-guided interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MHAVIE-Children	Assessment of Life Habits-LIFE-H	Inclusion
MQE	Measure of Environmental Quality (MQE)	Inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Collaborators: Université des Antilles, LAboratoire ACTES

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): June 3, 2019
• Study Completion (Actual): June 3, 2019

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: social participation; neurocognitive disorders
• Additional Relevant MeSH Terms: Mental Disorders; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Neurocognitive Disorders
• Other Study ID Numbers: PAP_RNI_2018/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No