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

Sobi

Status: Completed

Conditions: Hemophilia B; Hemophilia A

Treatments: Diagnostic Test: Hemophilia Joint Health Score (HJHS)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04731701

Sobi.HAEM89-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.