A Prospective Randomized Pilot Study on the Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Study and control groups will be compared with respect to the % of bleeds reported to the HTC and % of recommended therapy recorded in bleeding logs after a 6 month period
研究概览
简要总结
The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.
详细描述
The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.To do this subjects will be randomized into a control group and a group who will receive consistent counselling by a pharmacist about their bleeding logs.
The aims of the study are:
- To provide a new method of bleeding and treatment documentation in the home setting (logs) to adolescent subjects with Hemophilia A or B
- To counsel these subjects about adherence to their treatment regimen prescribed by physician and the importance of keeping accurate documentation of each bleeding episode and its treatment.
- To improve maintenance of logs, to allow for 1) assessment of bleeding frequency and treatment efficacy and 2) early detection of target joint bleeding and the potential need for prophylactic factor replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ages 12 through 20
- •Severe or moderate Hemophilia A or B
- •Self-infusing or transitioning to self infusion in the home setting
- •Already assigned responsibility of monitoring bleeding logs
排除标准
- •Not meeting inclusion criteria
研究组 & 干预措施
1
Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records.
干预措施: Counseling (Behavioral)
2
After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients.
干预措施: Control (Behavioral)
结局指标
主要结局
Study and control groups will be compared with respect to the % of bleeds reported to the HTC and % of recommended therapy recorded in bleeding logs after a 6 month period
时间窗: 6 months
次要结局
- Study and control groups will be compared with respect to time between initiation of target joint bleeding and the identification and treatment of such by HTC personnel(6 months)
- Clotting factor consumption and the cost of therapy in each group will be compared(6 months)