Brief Title
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
Official Title
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
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 functional mobility.
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 functional mobility for adult haemophilia patients.
Study Type
Observational
Primary Outcome
Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST).
Condition
Hemophilia A
Intervention
Hemophilia Joint Health Score (HJHS)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
180
Start Date
May 5, 2021
Completion Date
June 2022
Primary Completion Date
June 2022
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Elena Santagostino, MD, PhD, +46 8 697 2000, [email protected]
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04731701
Organization ID
Sobi.HAEM89-005
Responsible Party
Sponsor
Study Sponsor
Swedish Orphan Biovitrum
Collaborators
Kantar Health
Study Sponsor
Elena Santagostino, MD, PhD, Study Director, Swedish Orphan Biovitrum
Verification Date
February 2022