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

Swedish Orphan Biovitrum180 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Hemophilia A Hemophilia B

Interventions

Hemophilia Joint Health Score (HJHS)DIAGNOSTIC_TEST

Joint examination with Hemophilia Joint Health Score (HJHS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Swedish Orphan Biovitrum Clinical site

Paris, Cochin, France

Swedish Orphan Biovitrum Clinical site

Paris, Kremlin-Bicêtre, France

Swedish Orphan Biovitrum Clinical site

Outcomes

Primary Outcomes

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

Statistical analysis to confirm the psychometric validation of the Hemo-FAST questionnaire

Time frame: Baseline

Data from ClinicalTrials.gov

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