临床试验/NCT01322620

NCT01322620已完成不适用

Haemophilia, Experiences, Results and Opportunities (HERO): A Community-based Evaluation of the Psychosocial Effects of Haemophilia on Patients and Their Carers

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 1,236 人开始时间: 2011年6月3日最近更新: 2017年2月23日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 1,236
试验地点: 1
主要终点: To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is conducted in Africa, Asia, Europe, North America and South America.

The purpose of the survey 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

•Males with haemophilia A or B (with or without inhibitors)
•Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors)
•Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate))
•Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months
•Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey

排除标准

•Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative

结局指标

主要结局

To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives

时间窗: After 6 weeks (recruitment and data collection)

次要结局

To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being(After 6 weeks (recruitment and data collection))

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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