Säo Paulo, 05001-400, Brazil
NCT Number: NCT02241694
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Male
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.)
Treatment and study plan
No treatment given
OtherNo treatment given. Participants are to complete a questionnaire in the study.
Primary outcomes
-
Qualitative assessments of perceived impact on daily life
Time frame: Day 1
Secondary outcomes
-
Perceived disease control
Time frame: Day 1
-
Carrier status and reactions to haemophilia diagnosis
Time frame: Day 1
-
Genetic counselling and testing
Time frame: Day 1
-
Impact of haemophilia in siblings
Time frame: Day 1
-
Satisfaction with support from partners, family, friends, others
Time frame: Day 1
-
Sexual intimacy with partners in long-term relationships
Time frame: Day 1
-
Treatment method, compliance and location
Time frame: Day 1
-
Modified WHO-5 (World Health Organization-Five Well Being Index)
Time frame: Day 1
-
Knowledge and information about haemophilia
Time frame: Day 1
-
Improvements in haemophilia care
Time frame: Day 1
Sponsors and collaborators
Lead sponsor
Novo Nordisk A/S
Industry
Registry information
Official study title
Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers
Acronym: HERO
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 16, 2014
- Registry last updated
- Jul 10, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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