Systematic Psychological and Medical Care for Children With SCD

Anemia, Sickle Cell Clinical Trial

— Drépano  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022891
• Other study ID #: SC_MOE_2012-6
• Status: Completed
• Phase: N/A
• First received: August 28, 2013
• Last updated: August 5, 2014
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No