Clinical Trials Directory

Trials / Completed

CompletedNCT02022891

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?

Status
Completed
Phase
Study type
Observational
Enrollment
160 (estimated)
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALsystematic psychological carePrevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations.

Timeline

Start date
2013-01-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2013-12-30
Last updated
2014-08-06

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02022891. Inclusion in this directory is not an endorsement.