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

Novo Nordisk

Status: Completed

Conditions: Haemophilia B With Inhibitors; Haemophilia B; Haemophilia A With Inhibitors; Relatives to/Carers of Patients; Haemophilia A; Congenital Bleeding Disorder

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT02241694

U1111-1147-4202 (Other Identifier)

F7HAEM-4146

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

200 participants in 1 patient group

survey

Treatment:

Other: No treatment given