Brief Title
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
Official Title
Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers
Brief Summary
This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
Study Type
Observational
Primary Outcome
Qualitative assessments of perceived impact on daily life
Secondary Outcome
Perceived disease control
Condition
Congenital Bleeding Disorder
Intervention
No treatment given
Study Arms / Comparison Groups
survey
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
200
Start Date
November 2014
Completion Date
July 2015
Primary Completion Date
July 2015
Eligibility Criteria
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.)
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), GZZF, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02241694
Organization ID
F7HAEM-4146
Secondary IDs
U1111-1147-4202
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), GZZF, Study Director, Novo Nordisk A/S
Verification Date
July 2015