Clinical trial NCT02022891: Systematic Psychological and Medical Care for Children With SCD
Official title: The Impact of Systematic Psychological and Medical Care for Treatment of Pediatric Patients With SCD: : A Luxury or a Necessity?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Sickle Cell
Keywords: Sickle cell disease
psychological support
quality of life
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2013-12-30
Enrollment: 160
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with sickle cell disease

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.

Eligibility 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

Primary outcomes:
measure: psychological assessment and quality of life (quantitative and qualitative assessment)
timeFrame: baseline
Secondary outcomes:
measure: use of care-facilities: comparison between groups
timeFrame: baseline
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hôpital Louis Mourier
Study officials:
affiliation: Hôpital Louis Mourier, Colombes, France 92
name: Marie-Hélène ODIEVRE, MD
role: PRINCIPAL_INVESTIGATOR
References: