Quality of Life in Patients With Congenital Afibrinogenemia (QualyAFIB)

November 10, 2020 updated by: Casini Alessandro, University Hospital, Geneva
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algier, Algeria
        • Béni Messous
  • Canada
      • Calgary, Canada
        • University of Calgary
  • Egypt
      • Cairo, Egypt
        • Cairo University Pediatric Hospital
  • France
      • Lille, France
        • CHRU Lille
  • Germany
      • Frankfurt, Germany
        • Universitats Kilinikum Frankfurt
      • Munich, Germany
        • Dr von Haumer Children's Hospital
  • India
      • Bangalore, India
        • St John Medical College Hospital
      • New Delhi, India
        • All India Institute of Medical Sciences
  • Italy
      • Roma, Italy
        • Sapienza Università di Roma
  • Japan
      • Hamamatsu, Japan
        • University School of Medicine
  • Kuwait
      • Kuwait, Kuwait
        • Kuwait University
  • Lebanon
      • Beirut, Lebanon
        • Hotel Dieu-de-France
      • Beirut, Lebanon
        • St George Hospital
  • Morocco
      • Rabat, Morocco
        • Hopital d'Enfants de Rabat
  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Centre
  • Pakistan
      • Karachi, Pakistan
        • National Institute Of Blood Disease and Bone Marrow Transplantation
  • Poland
      • Warsaw, Poland
        • Institute of Hematology and Transfusion Medicine
  • Serbia
      • Belgrade, Serbia
        • University Clinical Center
  • Slovakia
      • Martin, Slovakia
        • National Centre of Hemostasis and Thrombosis
  • Spain
      • Valencia, Spain
        • Hospital Universitari i Politècnic La Fe
  • Switzerland
      • Bern, Switzerland
        • Inselspital
      • Geneva, Switzerland
        • University Hospitals of Geneva
  • Tunisia
      • Tunis, Tunisia
        • Hopital d'Enfants Bechir Hamza
  • Turkey
      • Bursa, Turkey
        • Uludag University
      • Istanbul, Turkey
        • Cerrahpasa Faculty of Medicine
      • Kayseri, Turkey
        • Erciyes University
  • United States
    • California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange Count
    • New York
      • New Hyde Park, New York, United States, 11040
        • Cohen Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from congenital afibrinogenemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Afibrinogenemia
Other: Questionnaire quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the afibrinogenemic patient's clinical phenotype on the patients' quality of life
Time Frame: 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)
At Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (ACTUAL)

March 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-00447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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