Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 458 for:    Inherited Bleeding Disorder

Input of a Multidisciplinary Device to Accompany the Announce of Diagnosis for Young Children With Serious Constitutional Hemorrhagic Disease and Their Families (ACADHEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02834130
Recruitment Status : Completed
First Posted : July 15, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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

Detailed Description:

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Treatment Exposure Days compared to the Number of Treatment Exposure days prescribed [ Time Frame: 2 years ]
    Treatment Observance


Secondary Outcome Measures :
  1. Assessment of patient's behavioral condition using the Child Behavior Check-list (CBCL) 1,5-5 [ Time Frame: 2 Years ]
  2. Assessment of the patient's body consciousness through the "CORP-R" test (french test of body mapping) [ Time Frame: 2 years ]
  3. Assessment of patient's quality of life using the "Kidscreen" questionnaire for children [ Time Frame: 2 years ]
  4. Assessment of the patient's parents' Qaulity of life through the Short Form Health Survey (SF-36) [ Time Frame: 2 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 3 and 12 years
  • Patients diagnosed and treated at the Center until inclusion
  • Patients with FVIII :C < 2% or with FIX :C <2% or with FVII:C <2% or with FXIII:C <2% or fibrinogen <0,2 g/l, or with type 3 von Willebrand diseases or Thrombasthenia of Glanzmann diseases.
  • Patient who participate to multidisciplinary support and announcement of diagnosis device
  • Voluntarily given fully informed written and signed consents obtained before any study-related procedures are conducted

Exclusion Criteria:

  • Patient with other clotting disorder or disease.
  • Patient diagnosed or treated in other centre
  • Patient with psychiatric disorder or disease
  • Patient with other severe chronic disease

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): NCT02834130


Locations
Layout table for location information
France
Hopital Enfants de la Timone Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille

Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02834130     History of Changes
Other Study ID Numbers: 2014-05
2014-A00367-40 ( Registry Identifier: Ansm )
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases