- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975699
Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children under 18 years old
- Major form of SCD (SS, SC, Sβ° thal, Sβ+ 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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients in centre 1: Louis-Mourier Hospital
All SCD follow-up consultations were conducted jointly by a paediatrician and a clinical psychologist.
|
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.
|
Patients in centre 2: Evry hospital
All SCD follow-up consultations were conducted by a paediatrician alone.
The unit had close links with the local psycho-medical paediatric care centre when specialized referrals were necessary.
|
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.
|
Patients in centre 3: Clamart hospital
All SCD follow-up consultations were conducted by a paediatrician alone.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rey-Osterrieth complex figure test scores (ROCF recall scores)
Time Frame: 1 day
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29185057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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