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Quality of Life and Adjustment Among Siblings of Children and Adolescents With Severe Hemophilia (FRATHEMO)

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ClinicalTrials.gov Identifier: NCT03299699
Recruitment Status : Not yet recruiting
First Posted : October 3, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Severe hemophilia is a rare and chronic disease characterized by spontaneous bleedings from early childhood, which may lead to various complications especially in joints. The diagnosis of this disease, but also its long term care have an impact on the relatives of the affected persons, including the siblings who bear daily the cognitive, emotional and social impacts of the disease.

Studies conducted in the framework of pediatric chronic diseases showed that siblings of affected children presented a higher prevalence of physical and psychological troubles (emotional distress, behavioral disorders, etc.) than siblings who were not concerned by a disease. Few studies have been conducted in the framework of severe hemophilia, and to our knowledge, no study addresses this issue in France.


Condition or disease
Severe Haemophilia

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FRATHEMO: Quality of Life and Adjustment Among Siblings of Children and Adolescents With Severe Hemophilia.
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Quality of life [ Time Frame: one day ]
    Kidscreen 10 Index


Secondary Outcome Measures :
  1. Emotional adjustment [ Time Frame: one day ]
    STAI questionnaire

  2. Coping strategies use [ Time Frame: one day ]
    Kidcope checklist

  3. Social support [ Time Frame: one day ]
    Child and Adolescent Social Support Scale



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
siblings of children and adolescents with severe hemophilia
Criteria

Inclusion Criteria:

  • Sibling (brother, sister, half-brother or half-sister) of older children or adolescents included in the TRANSHEMO study, who lives in the same home)
  • Sibling aged 8-18 years old
  • Sibling affiliated to the French social security system
  • Sibling whose parents are not opposed to the participation in the study

Exclusion Criteria:

  • Sibling (brother, sister, half-brother or half-sister) of older children or adolescents who are not included in the TRANSHEMO study)
  • Sibling aged under 8 or over 18 years old
  • Sibling not affiliated to the French social security system
  • Sibling whose parents are opposed to the participation in the study
  • Sibling with difficulties reading and writing
  • Sibling with learning disabilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299699


Contacts
Contact: Noémie RESSEGUIER 04 91 32 42 72 noemie.RESSEGUIER@univ-amu.fr

Locations
France
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Noémie RESSEGUIER    04 91 32 42 72    noemie.RESSEGUIER@univ-amu.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle Desalbres Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03299699     History of Changes
Other Study ID Numbers: 2017-06
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn