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Quality of Life in Patients With Congenital Afibrinogenemia (QualyAFIB)

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: NCT03484065
Recruitment Status : Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Casini Alessandro, University Hospital, Geneva

Tracking Information
First Submitted Date March 14, 2018
First Posted Date March 30, 2018
Last Update Posted Date July 30, 2019
Actual Study Start Date June 2016
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03484065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 23, 2018)
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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life in Patients With Congenital Afibrinogenemia
Official Title Quality of Life in Patients With Congenital Afibrinogenemia
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients suffering from congenital afibrinogenemia
Condition Afibrinogenemia, Congenital
Intervention Other: Questionnaire quality of life
Study Groups/Cohorts Afibrinogenemia
Intervention: Other: Questionnaire quality of life
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 29, 2019)
250
Original Estimated Enrollment
 (submitted: March 23, 2018)
150
Estimated Study Completion Date December 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Algeria,   Canada,   Egypt,   France,   Germany,   India,   Italy,   Japan,   Kuwait,   Lebanon,   Morocco,   Netherlands,   Pakistan,   Poland,   Serbia,   Slovakia,   Spain,   Switzerland,   Tunisia,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03484065
Other Study ID Numbers 2016-00447
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Casini Alessandro, University Hospital, Geneva
Study Sponsor University Hospital, Geneva
Collaborators Not Provided
Investigators
Principal Investigator: Alessandro Casini, MD University Hospitals of Geneva
PRS Account University Hospital, Geneva
Verification Date July 2019