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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

180

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started May 2021

Geographic Reach

1 country

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

November 24, 2020

Completed

2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2022

Completed

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

November 24, 2020

Last Update Submit

September 17, 2024

Conditions

Hemophilia A Hemophilia B

Outcome Measures

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
Baseline

Interventions

Hemophilia Joint Health Score (HJHS)DIAGNOSTIC_TEST

Joint examination with Hemophilia Joint Health Score (HJHS)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.