Status:
COMPLETED
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
Lead Sponsor:
Swedish Orphan Biovitrum
Collaborating Sponsors:
Kantar Health
Cerner Enviza (former Kantar Health)
Conditions:
Hemophilia A
Hemophilia B
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported f...
Detailed Description
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported f...
Eligibility Criteria
Inclusion
- A patient must fulfil the following criteria in order to be included in the study:
- Age ≥18 years.
- Diagnosis of haemophilia A or B.
- Capable of completing the study Patient-Reported Outcome (PRO) questionnaires in French.
- Signed informed consent.
Exclusion
- The presence of any of the following criteria will exclude a patient from inclusion in the study:
- Joint replacement within last 6 months.
- Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit.
- Patients with comorbid illnesses such as juvenile arthritis, muscular dystrophy, neurologic illness/cognitive impairment, or other illnesses that may independently affect HJHS and Hemo-FAST scores and/or limit the ability of the patient to participate in the study as determined by the investigator.
Key Trial Info
Start Date :
May 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04731701
Start Date
May 5 2021
End Date
July 19 2022
Last Update
September 19 2024
Active Locations (16)
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1
Swedish Orphan Biovitrum Clinical site
Paris, Cochin, France
2
Swedish Orphan Biovitrum Clinical site
Paris, Kremlin-Bicêtre, France
3
Swedish Orphan Biovitrum Clinical site
Besançon, France
4
Swedish Orphan Biovitrum Clinical site
Bordeaux, France