Effectiveness of the uPatient Platform in the Fulfillment of the Prophylactic Treatment in Patients With Hemophilia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Registration of the uPatient platform
研究概览
简要总结
Research project whose main objective is to evaluate the use of a technology platform (uPatient) to register the prophylactic treatment of patients with hemophilia treated in different Hematology and Hemotherapy services of several hospitals in Spain.
详细描述
The data obtained in this project will identify the level of compliance to the pharmacological treatment of patients with hemophilia prophylaxis. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for patients with hemophilia. Clinical data were also obtained regarding the joint of patients participating in the study state.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hemophilia A or B
- •Patients over 13 years old
- •Patients on prophylactic treatment.
排除标准
- •Patients who do not sign the informed consent document
- •Patients who do not make domiciliary self-treatment
- •Patients who do not have good adhesion to prophylactic treatment
结局指标
主要结局
Registration of the uPatient platform
时间窗: Screening visit
This register indicates the number of infusions
Change from baseline the perception of disease at 6 months and at the end of the study
时间窗: Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year
Questionnaire to evaluate the perception of disease (Questionnaire IPQ-R)
Change from baseline the quality of life at 6 months and at the end of the study
时间窗: Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year
Quality of life questionnaire (SF-36)
Change from baseline the compliance to the prophylactic treatment at 6 months and at the end of the study
时间窗: Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year
Spanish version of the questionnaire for compliance to prophylactic treatment in patients with haemophilia (Veritas-Pro).
Change from baseline the joint status at the end of the study
时间窗: Screening visit and through study completion, an average of 1 year
Spanish version of the Haemophilia Joint Health Score (HJHS), to assess the joint status in patients with hemophilia
次要结局
未报告次要终点