To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives

Completed

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

• Registration Number: NCT02241694
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Study Start: 2014-11
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

• Men aged 18 years or above with haemophilia A or B (with or without inhibitors) OR Parents/caregivers of children/adolescents younger than 18 years with haemophilia A or B (with or without inhibitors); only one subject per household will be able to participate
• Patients currently receiving one of the following treatments: a. replacement factor VIII therapy, b. replacement factor IX therapy, c. bypassing agents (recombinant factor VIIa or APCC) OR Patients with haemophilia, not receiving any kind of treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous haemorrhage into one or more joints within the last 12 months
• The participants (patients with haemophilia and parents/caregivers for patients under 18 years old) must be able to complete a paper questionnaire in order to participate in the study
• Providing informed consent before the start of any study-related activities

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Exclusion Criteria

• Inability for the patients or parents/caregivers to understand and comply with verbal instructions, unless assisted by a member of the HTC (Haemophilia Treatment Center) or by a relative. (No other conditions were established for patients who cannot read or write to be able to participate in this study in addition to the need of help from a member of HTC or by a relative.)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
survey	No treatment given	-

Primary Outcome Measures

Name	Time	Method
Qualitative assessments of perceived impact on daily life	Day 1

Secondary Outcome Measures

Name	Time	Method
Genetic counselling and testing	Day 1
Sexual intimacy with partners in long-term relationships	Day 1
Carrier status and reactions to haemophilia diagnosis	Day 1
Satisfaction with support from partners, family, friends, others	Day 1
Treatment method, compliance and location	Day 1
Knowledge and information about haemophilia	Day 1
Perceived disease control	Day 1
Impact of haemophilia in siblings	Day 1
Improvements in haemophilia care	Day 1
Modified WHO-5 (World Health Organization-Five Well Being Index)	Day 1