Quality of Life in Patients With Congenital Afibrinogenemia
- Conditions
- Afibrinogenemia, Congenital
- Interventions
- Other: Questionnaire quality of life
- Registration Number
- NCT03484065
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.
- Detailed Description
In this observational study, children and adults suffering from congenital afibrinogenemia confirmed by biology will be enrolled. All patients will receive a questionnaire on quality of life in their own language during a routine visit and filled out by the patient at home. A general questionnaire will be filled out by the patient's physician.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Congenital afibrinogenemia confirmed by biology (absence of circulating fibrinogen) and genotype
- Lack of participant's consent
- Patient unable to understand the questionnaire
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Afibrinogenemia Questionnaire quality of life -
- Primary Outcome Measures
Name Time Method The influence of the afibrinogenemia on the patients' quality of life assessed by the Haemo-QoL SF questionnaire (for children) and the Haem-A-QoL questionnaire (for adult) At inclusion The quality of life questionnaire includes item assessing:
* Physical health
* Feeling
* View
* Family
* Friends
* Others
* Sport and school
* Treatment
* Perceived support
* Dealing
* Future
* Relationship
- Secondary Outcome Measures
Name Time Method Impact of the afibrinogenemic patient's clinical phenotype on the patients' quality of life At Inclusion The clinical phenotype will be assessed by a general questionnaire including data on:
* Bleeding events
* Bleeding events treatment
* Thrombotic events
* Thrombotic events treatment
* Fibrinogen replacement (type of product and modality of replacement)
Trial Locations
- Locations (28)
Universitats Kilinikum Frankfurt
🇩🇪Frankfurt, Germany
Cohen Children's Medical Center
🇺🇸New Hyde Park, New York, United States
St George Hospital
🇱🇧Beirut, Lebanon
Chru Lille
🇫🇷Lille, France
National Centre of Hemostasis and Thrombosis
🇸🇰Martin, Slovakia
Inselspital
🇨🇭Bern, Switzerland
Béni Messous
🇩🇿Algier, Algeria
National Institute Of Blood Disease and Bone Marrow Transplantation
🇵🇰Karachi, Pakistan
Uludag University
🇹🇷Bursa, Turkey
Hopital d'Enfants de Rabat
🇲🇦Rabat, Morocco
Children's Hospital of Orange Count
🇺🇸Orange, California, United States
Sapienza Università di Roma
🇮🇹Roma, Italy
University Clinical Center
🇷🇸Belgrade, Serbia
University of Calgary
🇨🇦Calgary, Canada
Cairo University Pediatric Hospital
🇪🇬Cairo, Egypt
University School of Medicine
🇯🇵Hamamatsu, Japan
Hotel Dieu-de-France
🇱🇧Beirut, Lebanon
St John Medical College Hospital
🇮🇳Bangalore, India
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Radboud University Medical Centre
🇳🇱Nijmegen, Netherlands
Erciyes University
🇹🇷Kayseri, Turkey
Institute of Hematology and Transfusion Medicine
🇵🇱Warsaw, Poland
Cerrahpasa Faculty of Medicine
🇹🇷Istanbul, Turkey
University Hospitals of Geneva
🇨🇭Geneva, Switzerland
Hopital d'Enfants Bechir Hamza
🇹🇳Tunis, Tunisia
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Dr von Haumer Children's Hospital
🇩🇪Munich, Germany
Kuwait University
🇰🇼Kuwait, Kuwait