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

September 17, 2024 updated by: Swedish Orphan Biovitrum
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Swedish Orphan Biovitrum Clinical site
    • Cochin
      • Paris, Cochin, France
        • Swedish Orphan Biovitrum Clinical site
    • Kremlin-Bicêtre
      • Paris, Kremlin-Bicêtre, France
        • Swedish Orphan Biovitrum Clinical site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Orphan Biovitrum

Collaborators

Kantar Health
Cerner Enviza (former Kantar Health)

Investigators

  • Study Director: Study Physician, Swedish Orphan Biovitrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

July 19, 2022

Study Completion (Actual)

July 19, 2022

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.HAEM89-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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