Study of a Smart Sharps Disposal in Patients With Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
This pilot study will have patients use a smart sharps disposal container at home for disposal of needles used to administer their hemophilia drugs. The study aims to find out if the smart sharps container proved acceptable to use by patients and medical providers and can be adhered to.
详细描述
Preventative factor or non-factor product IV administration has been shown to improve outcomes in patients with hemophilia. The need for patients to log their doses or complete questionnaires can be burdensome. This study seeks to use novel technology, a smart sharps container that records disposal of the needle used to administer preventive products. We will perform a prospective study of adult patients with hemophilia A/B who are on factor or non-factor products. They will all be given the device to take home and use there.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥18 years of age
- •Moderate or Severe Hemophilia A or B, with or without an inhibitor
- •Prescribed prophylaxis with either a factor product or emicizumab that is scheduled to be given at least once every 14 days
排除标准
- •Stated inability to use the SharpsCue container
- •Treatment with another investigational drug or other intervention during the study period
- •Patients on prophylactic dosing less than once every 14 days
- •Patients who are infused by a home nurse
研究组 & 干预措施
intervention of being given device to use
needle disposal device
干预措施: The smart Sharps device is given to the patient and they use it to throw needles away in. It is not internal to the patient. (Other)
结局指标
主要结局
Adherence
时间窗: Days 1-180
% from baseline to active phase that patient adheres to using needle disposal
次要结局
- Patient and provider satisfaction survey(Day 181 +/- 7 days)
研究者
Allyson Pishko
Assistant Professor
University of Pennsylvania