Systematic Psychological and Medical Care for Children With SCD

NCT02022891 | Completed

• 1 other identifier: SC_MOE_2012-6
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Sickle Cell

Keywords

Sickle cell disease; psychological support; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• use of care-facilities: comparison between groups

  baseline

Study Arms (2)

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

Interventions

systematic psychological care BEHAVIORAL

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

Control

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children with sickle cell disease

You may qualify if:

• 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.

You may not qualify if:

• Refusal of the parents or the child to participate.
• Child or parent living in France for less than 6 months

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Louis Mourier

Colombes, 92, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marie-Hélène ODIEVRE, MD

  Hôpital Louis Mourier, Colombes, France 92

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

FR (1)