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NCT04731701 Clinical Trial

Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

Hemophilia A Clinical Trial

— Hemo-FAST  

Official title:
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04731701
Other study ID # Sobi.HAEM89-005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 5, 2021
Est. completion date July 19, 2022

Study information
Verified date August 2022
Source Swedish Orphan Biovitrum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 functional mobility.

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 functional mobility for adult haemophilia patients.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date July 19, 2022
Est. primary completion date July 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:A patient must fulfil the following criteria in order to be included in the study: 1. Age =18 years. 2. Diagnosis of haemophilia A or B. 3. Capable of completing the study Patient-Reported Outcome (PRO) questionnaires in French. 4. Signed informed consent. Exclusion Criteria: The presence of any of the following criteria will exclude a patient from inclusion in the study: 1. Joint replacement within last 6 months. 2. Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or = 7 days prior to the enrolment visit. 3. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Hemophilia Joint Health Score (HJHS)
Joint examination with Hemophilia Joint Health Score (HJHS)

Locations
Country Name City State
France Swedish Orphan Biovitrum Clinical site Besançon
France Swedish Orphan Biovitrum Clinical site Bordeaux
France Swedish Orphan Biovitrum Clinical site Brest
France Swedish Orphan Biovitrum Clinical site Caen
France Swedish Orphan Biovitrum Clinical site Clermont-Ferrand
France Swedish Orphan Biovitrum Clinical site Dijon
France Swedish Orphan Biovitrum Clinical site Lyon
France Swedish Orphan Biovitrum Clinical site Marseille
France Swedish Orphan Biovitrum Clinical site Nancy
France Swedish Orphan Biovitrum Clinical site Nantes
France Swedish Orphan Biovitrum Clinical site Paris Cochin
France Swedish Orphan Biovitrum Clinical site Paris Kremlin-Bicêtre
France Swedish Orphan Biovitrum Clinical site Rouen
France Swedish Orphan Biovitrum Clinical site Saint-Étienne
France Swedish Orphan Biovitrum Clinical site Strasbourg
France Swedish Orphan Biovitrum Clinical site Toulouse

Sponsors (3)
Lead Sponsor Collaborator
Swedish Orphan Biovitrum Cerner Enviza (former Kantar Health), Kantar Health

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST). Statistical analysis to confirm the psychometric validation of the Hemo-FAST questionnaire Baseline
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