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

• ClinicalTrials.gov Identifier: NCT03975699
• Recruitment Status: Completed
• First Posted: June 5, 2019
• Last Update Posted: September 17, 2021
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Information provided by (Responsible Party): Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information

• First Submitted Date: June 4, 2019
• First Posted Date: June 5, 2019
• Last Update Posted Date: September 17, 2021
• Actual Study Start Date: February 2013
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 10, 2021)

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).

• Original Primary Outcome Measures (submitted: June 4, 2019): ROCF recall scores (Rey-Osterrieth complex figure test) [ Time Frame: 1 day ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
• Official Title: Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Children suffering from SCD and their parents, consulting in one of the 3 hospitals.
• Condition: Sickle Cell Disease

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.

Study Groups/Cohorts

• Patients in centre 1: Louis-Mourier Hospital
  All SCD follow-up consultations were conducted jointly by a paediatrician and a clinical psychologist.
  Intervention: Other: Assessment of psychological repercussions of SCD
• 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.
  Intervention: Other: Assessment of psychological repercussions of SCD
• Patients in centre 3: Clamart hospital
  All SCD follow-up consultations were conducted by a paediatrician alone.
  Intervention: Other: Assessment of psychological repercussions of SCD

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 4, 2019): 155
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03975699
• Other Study ID Numbers: 29185057
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• Original Responsible Party: Same as current
• Current Study Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fondation Ophtalmologique Adolphe de Rothschild
• Verification Date: September 2021