Sickle Cell Disease, Neurocognitive Disorders, Social Participation

NCT04793854 | Completed

• 1 other identifier: PAP_RNI_2018/02
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

neurocognitive disorders; social participation

Outcome Measures

Primary Outcomes (2)

• MHAVIE-Children

  Assessment of Life Habits-LIFE-H

  Inclusion

• MQE

  Measure of Environmental Quality (MQE)

  Inclusion

Study Arms (2)

Case

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

Other: Measure of the Life habits (MHAVIE)

Control

Control children without chronical disease

Other: Measure of the Life habits (MHAVIE)

Interventions

Measure of the Life habits (MHAVIE) 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,…).

Also known as: Measure of Environmental Quality (MQE), semi-guided interviews

Case; Control

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead
• Université des Antilles, LAboratoire ACTES: collaborator

Study Sites (1)

CHU de la Guadeloupe

Pointe-à-Pitre, France, 97139, Guadeloupe

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: September 19, 2018
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)