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临床试验/NCT03000023
NCT03000023已完成不适用

A Qualitative and Quantitative Evaluation of Patients' Anticipated and Perceived Treatment Benefits Following HCV Viral Eradication

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.

研究概览

简要总结

The study is both qualitative and quantitative, gathering patient's perceptions of HCV treatment benefits before and after HCV treatment by administering surveys and conducting in-depth qualitative patient interviews. The study seeks to understand all anticipated and actual benefits patients perceive before and after viral eradication.

详细描述

This study employs a mixed methods (qualitative and quantitative) pre-post study design utilizing in-depth qualitative interviews and patient reported outcome surveys. Pre-treatment surveys and interviews will be conducted before HCV therapy commences to understand all potential psychological, social, physical and medical consequences perceived to be related to HCV and the patients' anticipation (hope for) of improvements in these factors after viral eradication. Post-treatment surveys and interviews will occur 4 to 8 months after treatment ends to examine long-term treatment benefits, i.e., changes in HCV-related factors, such as symptoms, functioning, and health status.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 or older
  • English-speaking
  • Any genotype
  • Any treatment duration (e.g. 8, 12, or 24 weeks)
  • Has been written a prescription for a sofosbuvir (SOF)-containing regimen.

排除标准

  • Currently listed for liver transplant; post-liver transplant

结局指标

主要结局

Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.

时间窗: 1 Year

To conduct a pre-post qualitative analysis that will evaluate changes in a broad range of patients' perceptions of psychological, social, and physical effects associated with HCV and viral cure collected through qualitative interviews.

Evaluate pre-post survey change in patient reported HCV symptoms and other factors.

时间窗: 1 Year

To conduct a pre-post survey evaluation of change in patient-reported HCV symptoms, functioning, and health perceptions associated with HCV and viral cure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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