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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03975699
Other study ID # 29185057
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2013
Est. completion date April 2014

Study information

Verified date September 2021
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sickle cell disease (SCD) necessitates a paediatric treatment plan that considers the influence of psychological, family and intercultural factors. At the Louis-Mourier Hospital (APHP) in Colombes, France, a paediatric-psychological partnership where a clinical psychologist accompanies the paediatrician at programmed consultations was introduced. The psychological repercussions of SCD were assessed among children and their parents treated in Colombes and in two other paediatric units without a paediatric-psychological partnership.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Children under 18 years old - Major form of SCD (SS, SC, Sß° thal, Sß+ thal) diagnosed by electrophoresis Exclusion Criteria: - Child or parent residing in France less than 6 months - Having received SCD treatment in more than one centre

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment of psychological repercussions of SCD
Quantitative relevant data culled from medical files and qualitative analysis based on data gathered from child and parent interviews, were collected in the three hospitals.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type Measure Description Time frame Safety issue
Primary Rey-Osterrieth complex figure test scores (ROCF recall scores) The Rey-Osterrieth complex figure test (ROCF) is a neuropsychological assessment in which patients are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Scoring of drawings is based on the widely used 36-point scoring system (0 being the worst score and 36 the best). 1 day
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