Clinical trial NCT04731701: Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
Official title: Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Hemophilia B
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: Kantar Health
name: Cerner Enviza (former Kantar Health)
First posted: 2021-02-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from 10-15 haemophilia treatment centres (HTCs) across France. The lower age limit of 18 years has been chosen because Hemo-FAST was developed to be used among the adult population. Age is an important contributor to the development of joint damage. Enrolment will therefore be targeted so that there will be similar numbers of patients enrolled across three age groups: 18-29, 30-44 and ≥ 45-years old.

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.

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.

Primary outcomes:
measure: Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST).
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Swedish Orphan Biovitrum Clinical site
state: Cochin
city: Paris
country: France
facility: Swedish Orphan Biovitrum Clinical site
state: Kremlin-Bicêtre
city: Besançon
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Bordeaux
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Brest
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Caen
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Clermont-Ferrand
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Dijon
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Lyon
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Marseille
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Nancy
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Nantes
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Rouen
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Saint-Étienne
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Strasbourg
country: France
facility: Swedish Orphan Biovitrum Clinical site
city: Toulouse
country: France
facility: Swedish Orphan Biovitrum Clinical site
Study officials:
affiliation: Swedish Orphan Biovitrum
name: Study Physician
role: STUDY_DIRECTOR
References: