CClinicalTrials.gg
CompletedNCT04731701Hemo-FASTUpdated Sep 19, 2024

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

An observational study in Hemophilia A and Hemophilia B, sponsored by Swedish Orphan Biovitrum. Completed at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Swedish Orphan Biovitrum · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemophilia A
  • Hemophilia B
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In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's enrollment of 180 is above the median of 80 across 314 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Swedish Orphan Biovitrum is the lead sponsor of 78 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
180 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testHemophilia Joint Health Score (HJHS)

    Joint examination with Hemophilia Joint Health Score (HJHS)

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

16 sites
  • Swedish Orphan Biovitrum Clinical site
    Paris, Cochin, France
  • Swedish Orphan Biovitrum Clinical site
    Paris, Kremlin-Bicêtre, 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
    Rouen, France
  • Swedish Orphan Biovitrum Clinical site
    Saint-Étienne, France
  • Swedish Orphan Biovitrum Clinical site
    Strasbourg, France
  • Swedish Orphan Biovitrum Clinical site
    Toulouse, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04731701
Lead sponsor
Swedish Orphan Biovitrum
Collaborators
Kantar Health, Cerner Enviza (former Kantar Health)
Responsible party
Sponsor
First posted
Feb 1, 2021
Start date
May 5, 2021
Primary completion
Jul 19, 2022
Completion
Jul 19, 2022
Last update
Sep 19, 2024

Study contacts

Study Physician
study director · Swedish Orphan Biovitrum

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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