Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning

September 10, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children suffering from SCD and their parents, consulting in one of the 3 hospitals.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.
Patients in centre 3: Clamart hospital
All SCD follow-up consultations were conducted by a paediatrician alone.
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29185057

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

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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