Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors, Relatives to/Carers of Patients
Conditions
Brief summary
This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
Interventions
OTHERNo treatment given
No treatment given. Participants are to complete a questionnaire in the study.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Qualitative assessments of perceived impact on daily life | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Carrier status and reactions to haemophilia diagnosis | Day 1 |
| Genetic counselling and testing | Day 1 |
| Impact of haemophilia in siblings | Day 1 |
| Satisfaction with support from partners, family, friends, others | Day 1 |
| Perceived disease control | Day 1 |
| Treatment method, compliance and location | Day 1 |
| Modified WHO-5 (World Health Organization-Five Well Being Index) | Day 1 |
| Knowledge and information about haemophilia | Day 1 |
| Improvements in haemophilia care | Day 1 |
| Sexual intimacy with partners in long-term relationships | Day 1 |
Countries
Brazil
Outcome results
None listed