Systematic Psychological and Medical Care for Children With SCD

The Impact of Systematic Psychological and Medical Care for Treatment of Pediatric Patients With SCD: : A Luxury or a Necessity?

Sponsors

Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Source Fondation Ophtalmologique Adolphe de Rothschild
Brief Summary

Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model used is systematic psychological and medical care. Our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.

Detailed Description

In this observational multicentric pilot study, our goal is to assess the effectiveness of a systematic medical-psychological approach in place for the past 6 years at the Louis Mourier Hospital, as compared to the usual practice in 2 other pediatric hospitals for SCD which focus essentially on the medical issues associated with SCD. Two psychologists will interview 80 children and their primary care-takers at Louis Mourier hospital, and 80 children and their care-takers of the other two centers, using a standard comprehensive care for SCD. For the parents, we propose to use a semi-structured interview including a prepared interview guide, the Loneliness Questionnaire, and the parents' version of KIDSCREEN (10 items). For the children, according to their age, The Rey-Osterrieth Complex Figure Test (ROCF), the Draw a Person in the Rain Test (DPR), the KIDSCREEN questionnaire, and semi-directed interview will be used. Relevant information from the patients' medical record directly related to the symptomatic expression of the SCD will be noted on a data collection form. This phase is scheduled to last 12 months. A statistical and qualitative analysis of the results will be carried out at the end of the study.

Overall Status Completed
Start Date January 2013
Completion Date May 2014
Primary Completion Date May 2014
Study Type Observational
Primary Outcome
Measure Time Frame
psychological assessment and quality of life (quantitative and qualitative assessment) baseline
Secondary Outcome
Measure Time Frame
use of care-facilities: comparison between groups baseline
Enrollment 160
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: systematic psychological care

Description: Prevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations.

Arm Group Label: Control

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- children with sickle cell disease

- treated in one of the three investigational centers

- All major forms of the disease will be studied regardless of the country of origin.

Exclusion Criteria:

- Refusal of the parents or the child to participate.

- Child or parent living in France for less than 6 months

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Marie-Hélène ODIEVRE, MD Principal Investigator Hôpital Louis Mourier, Colombes, France 92
Location
Facility: Hôpital Louis Mourier
Location Countries

France

Verification Date

August 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: systematic psychological care

Description: Systematic psychological treatment plan added to medical care for children with SCD. Bio-psychosocial paradigm applied at pediatric consultations.

Label: Control

Description: medical care only at routine pediatric consultations for SCD. Psychological support provided only when the pediatrician consider it appropriate.

Acronym Drépano
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov