To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors; Relatives to/Carers of Patients
Intervention: No treatment given (Other)
Phase: N/A
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Global Clinical Registry (GCR, 1452), GZZF, Study Director, Affiliation: Novo Nordisk A/S
Summary
This survey is conducted in South America. The purpose is to identify the key psychosocial
issues affecting patients with haemophilia.
Clinical Details
Official title: Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers
Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional
Primary outcome: Qualitative assessments of perceived impact on daily life
Secondary outcome: Perceived disease controlCarrier status and reactions to haemophilia diagnosis Genetic counselling and testing Impact of haemophilia in siblings Satisfaction with support from partners, family, friends, others Sexual intimacy with partners in long-term relationships Treatment method, compliance and location Modified WHO-5 (World Health Organization-Five Well Being Index) Knowledge and information about haemophilia Improvements in haemophilia care
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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.)
Locations and Contacts
Säo Paulo 05001-400, Brazil
Additional Information
Clinical Trials at Novo Nordisk
Starting date: November 2014
Last updated: July 9, 2015
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