Quality of Life in Patients With Congenital Afibrinogenemia

Completed

• Conditions: Afibrinogenemia, Congenital

• 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Primary Completion: 2019-07
• Study Completion: 2020-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Congenital afibrinogenemia confirmed by biology (absence of circulating fibrinogen) and genotype

Exclusion Criteria

• Lack of participant's consent
• Patient unable to understand the questionnaire

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

Children's Hospital of Orange Count; 🇺🇸 Orange, California, United States

Cohen Children's Medical Center; 🇺🇸 New Hyde Park, New York, United States

Béni Messous; 🇩🇿 Algier, Algeria

University of Calgary; 🇨🇦 Calgary, Canada

Cairo University Pediatric Hospital; 🇪🇬 Cairo, Egypt

Chru Lille; 🇫🇷 Lille, France

Universitats Kilinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Dr von Haumer Children's Hospital; 🇩🇪 Munich, Germany

St John Medical College Hospital; 🇮🇳 Bangalore, India

All India Institute of Medical Sciences; 🇮🇳 New Delhi, India

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