NCT02241694已完成不适用
Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Qualitative assessments of perceived impact on daily life
研究概览
简要总结
This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Qualitative assessments of perceived impact on daily life
时间窗: Day 1
次要结局
- Genetic counselling and testing(Day 1)
- Sexual intimacy with partners in long-term relationships(Day 1)
- Carrier status and reactions to haemophilia diagnosis(Day 1)
- Satisfaction with support from partners, family, friends, others(Day 1)
- Treatment method, compliance and location(Day 1)
- Knowledge and information about haemophilia(Day 1)
- Perceived disease control(Day 1)
- Impact of haemophilia in siblings(Day 1)
- Improvements in haemophilia care(Day 1)
- Modified WHO-5 (World Health Organization-Five Well Being Index)(Day 1)
研究者
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