Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03975699
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Sickle Cell Disease Other: Assessment of psychological repercussions of SCD

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 155 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
Actual Study Start Date : February 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes 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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03975699    
Other Study ID Numbers: 29185057
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
paediatric-psychological partnership
child
mental health
integrated care
well-being
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn