Skip to main content
OpenTrials
Completed

NCT Number: NCT04731701

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish Orphan Biovitrum Clinical site, Paris, Cochin, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A patient must fulfil the following criteria in order to be included in the study:

  • Age ≥18 years.
  • Diagnosis of haemophilia A or B.
  • Capable of completing the study Patient-Reported Outcome (PRO) questionnaires in French.
  • Signed informed consent.

Exclusion criteria

The presence of any of the following criteria will exclude a patient from inclusion in the study:

  • Joint replacement within last 6 months.
  • Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit.
  • 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.

Treatment and study plan

Hemophilia Joint Health Score (HJHS)

Diagnostic Test

Joint examination with Hemophilia Joint Health Score (HJHS)

Primary outcomes

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

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Collaborators

  • Cerner Enviza (former Kantar Health)
  • Kantar Health

Registry information

Acronym: Hemo-FAST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.