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临床试验/NCT05462288
NCT05462288已完成不适用

Entia Liberty: Home Study - Evaluation of Patient Preference for a Novel Full Blood Count Home Testing Device Versus Routine Venous Monitoring

Entia Ltd1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Entia Ltd
入组人数
22
试验地点
1
主要终点
To assess patient preference for the Liberty self-testing pathway as compared to standard of care.

研究概览

简要总结

Participants will be testing with the home monitoring device over the course of their treatment. They are to self-test on days where they are due to be going into hospital for their routine pre-treatment blood tests. Participants will be asked to fill in interim questionnaires and a final questionnaire to answer the study objectives.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adequate English language skills (not requiring a translator) to participate in participant training and use the Liberty device
  • Patients willing and able to perform capillary blood self-testing at the same frequency as routine full blood count monitoring
  • Patients capable of providing informed consent before attending training
  • Patients able to attend a 1-hour virtual training session within 2 weeks of joining the study
  • Patients with a home Wi-Fi network or with adequate coverage at home via a 4G network
  • Patients with access to a laptop or smartphone to facilitate training
  • Patients with a diagnosis of ovarian or breast cancer
  • Patients whose HCPs can confirm are undergoing systemic anti-cancer treatments within two weeks of enrolment, with treatment expected to continue for at least two cycles

排除标准

  • Patients with haematological malignancies
  • Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Liberty device or participation in training unless they have a nominated caregiver who is capable of assisting with each test

结局指标

主要结局

To assess patient preference for the Liberty self-testing pathway as compared to standard of care.

时间窗: 12 months

Patients will undergo the study procedures without change to their current pathway, at the end of the study, patients will compare the interventions via a SURVEY. The investigators will measure the success of the comparison by the % of patients who have chosen the investigators' product over the standard of care (4-5 rating out of 5).

次要结局

未报告次要终点

研究者

发起方
Entia Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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