Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination

Study Overview
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Brief Summary
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This low interventional study aims to describe if and how the haemophilia treatment management decisions are impacted by a systematic joint examination (ultrasound, functional, physical) in patients with haemophilia A in France.

Detailed Description
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The study will assess the behavior of the physicians with regards to haemophilia management decisions, and if systematic joint examination have an impact on their decisions. The main objective is to evaluate if the use of HEAD-US and Haemophilia Joint Health Score (HJHS) have an impact on these decisions. The study is classified as a low-interventional study due to mandated systematically assessment (HEAD-US, HJHS) on patients which may not be part of routine clinical practice.

Official Title
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A Study to Investigate if the Use of a Systematic Joint Examination (Ultrasound/Functional/Physical) Has an Impact on the Physician's Haemophilia Treatment Management Decision in Patients With Haemophilia

Conditions
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Hemophilia A

Intervention / Treatment
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* Procedure: Ultrasound, Haemophilia Joint Health Score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6-40 years Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII) At least one joint bleeding episode prior to inclusion Signed informed consent Exclusion Criteria: Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product, within three months prior to inclusion in the study Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit [BU]/mL) at the latest available inhibitor test Joint surgery over the past year prior to inclusion in one of the following joints; left knee, right knee, left elbow, right elbow, left ankle and right ankle More than one joint replacement

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Haemophilia A patients<br>Treated on-demand or prophylaxis with any Factor VIII (FVIII) product, plasma derived or recombinant (conventional or extended-half life) FVIII, according to routine clinical practice. | Procedure: Ultrasound, Haemophilia Joint Health Score<br>* Systematic joint examinations of ankles, knees and elbows<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US | Yes/No | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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joint health