Survey Evaluating the Psychosocial Effects of Living With Haemophilia

Completed

• Conditions: Haemophilia B With Inhibitors; Congenital Bleeding Disorder; Haemophilia B; Haemophilia A With Inhibitors; Relatives to/Carers of Patients; Haemophilia A
• Interventions: Other: No treatment given

• Registration Number: NCT01322620
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Africa, Asia, Europe, North America and South America.

The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Study Start: 2011-06-03
• Primary Completion: 2012-02-29
• Study Completion: 2012-02-29
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1236

Inclusion Criteria

• Males with haemophilia A or B (with or without inhibitors)
• Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors)
• Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate))
• Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months
• Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey

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Exclusion Criteria

• Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	No treatment given	-

Primary Outcome Measures

Name	Time	Method
To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives	After 6 weeks (recruitment and data collection)

Secondary Outcome Measures

Name	Time	Method
To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being	After 6 weeks (recruitment and data collection)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Crawley, United Kingdom