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

NCT ID: NCT04731701

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-05

Study Completion Date

2022-07-19

Brief Summary

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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

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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.

Conditions

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Hemophilia A Hemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Hemophilia Joint Health Score (HJHS)

Joint examination with Hemophilia Joint Health Score (HJHS)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantar Health

INDUSTRY

Sponsor Role collaborator

Cerner Enviza (former Kantar Health)

UNKNOWN

Sponsor Role collaborator

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Physician

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum

Locations

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Swedish Orphan Biovitrum Clinical site

Paris, Cochin, France

Site Status

Swedish Orphan Biovitrum Clinical site

Paris, Kremlin-Bicêtre, France

Site Status

Swedish Orphan Biovitrum Clinical site

Besançon, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Bordeaux, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Brest, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Caen, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Clermont-Ferrand, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Dijon, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Lyon, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Marseille, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Nancy, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Nantes, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Rouen, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Saint-Etienne, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Strasbourg, , France

Site Status

Swedish Orphan Biovitrum Clinical site

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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Sobi.HAEM89-005

Identifier Type: -

Identifier Source: org_study_id

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