Input of a Multidisciplinary Device to Accompany the Announce of Diagnosis for Young Children With Serious Constitutional Hemorrhagic Disease and Their Families (ACADHEM)
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|ClinicalTrials.gov Identifier: NCT02834130|
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : July 19, 2016
Severe forms of hemophilia and other constitutional bleeding disorders represent a group of rare diseases. In last decades, news therapies have dramatically increased life expectancy and joint's protection.
The investigators propose to set up a single-centre, descriptive, transversal pilot study, designed for the inclusion of around thirty children from 2 to 10 years, with haemophilia or allied hereditary bleeding disorders (HBD), who were referred to the Hemophilia Treatment Center (HTC) of Marseille at diagnosis. For those children who were able to benefit from the totality or part of the device accompanying the diagnostic announcement in the past 10 years.
|Condition or disease||Intervention/treatment||Phase|
|Severe Forms of Hemophilia Other Constitutional Bleeding Disorders||Behavioral: Evaluation of psychological and psychopathological||Not Applicable|
Severe forms of hemophilia and other constitutional bleeding disorders represent a group of rare diseases. In last decades, news therapies have dramatically increased life expectancy and joint's protection. The recurrence of joint bleedings is responsive of multifocal arthropathy in the natural history, but nowadays, the orthopedic outcome is good thanks to prophylactic treatments.
However, the announcement of the diagnosis of such hereditary bleeding disorders at a very young age represents a real psychological trauma for parents. Such an announcement may induce some psycho-developmental impairment.
An innovative support has been implemented at the Hemophilia Treatment Center in Marseille, in conjunction with the French Hemophilia Society. This program is based on a multidisciplinary partnership that favors the psychological support and the reinsurance of the parents.
With Rare Diseases Foundation support, the investigators have initiated this pilot study that will include more than 20 patients with severe hemophilia or constitutional bleeding disorder, who benefit from the device. This descriptive, monocentric, interventional study will permit to describe the psychological status, the quality of life of patients and their parents, but also to evaluate the impact of the device on initiation and observance of treatments like Long Term Prophylaxis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Input of a Multidisciplinary Device Including a Psychological Approach, to Accompany the Announce of Diagnosis for Young Children With Serious Constitutional Hemorrhagic Disease and Their Families|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||April 2016|
|children from 2 to 10 years with haemophilia or allied HBD, wh||
Behavioral: Evaluation of psychological and psychopathological
Other Name: Evaluation of quality of life
- Number of Treatment Exposure Days compared to the Number of Treatment Exposure days prescribed [ Time Frame: 2 years ]Treatment Observance
- Assessment of patient's behavioral condition using the Child Behavior Check-list (CBCL) 1,5-5 [ Time Frame: 2 Years ]
- Assessment of the patient's body consciousness through the "CORP-R" test (french test of body mapping) [ Time Frame: 2 years ]
- Assessment of patient's quality of life using the "Kidscreen" questionnaire for children [ Time Frame: 2 years ]
- Assessment of the patient's parents' Qaulity of life through the Short Form Health Survey (SF-36) [ Time Frame: 2 Years ]
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): NCT02834130
|Hopital Enfants de la Timone Assistance Publique Hôpitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||Urielle DESALBRES||Assistance Publique Hôpitaux de Marseille|