Systematic Psychological and Medical Care for Children With SCD (Drépano)

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia, Sickle Cell
• Intervention / Treatment: Behavioral: systematic psychological care

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.

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• France
  • Colombes, France, 92
    • Hôpital Louis Mourier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children with sickle cell disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
systematic psychological care; Systematic psychological treatment plan added to medical care for children with SCD. Bio-psychosocial paradigm applied at pediatric consultations.
Control; medical care only at routine pediatric consultations for SCD. Psychological support provided only when the pediatrician consider it appropriate.	Behavioral: systematic psychological care; Prevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychological assessment and quality of life (quantitative and qualitative assessment)	quality of life (scales, semi-directive interviews, drawings), psychological assessment of the children and their parent	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
use of care-facilities: comparison between groups	retrospective (back to 2006) collection of the number of hospitalizations (with mean length of stay) and number of emergency care experiences (and reasons) , number of children requiring the support of other care professionals for their SCD (Medico-Psychological center, orthophonist, neuro-pediatrician, psychologist..)	baseline

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Marie-Hélène ODIEVRE, MD, Hôpital Louis Mourier, Colombes, France 92

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: quality of life; Sickle cell disease; psychological support
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: SC_MOE_2012-6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No