Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire
研究概览
简要总结
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
详细描述
In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be conducted. The aims of the concept elicitation interviews are to:
- Identify the most common symptoms, as well as the most important symptoms, for patients with PSC, and
- Assess whether these symptoms impact day-to-day functioning
An instrument will be developed based on the symptoms reported and in Step II of the study, the performance of the instrument will be assessed with further interviews.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis made at least three months prior to screening
- •Patient report of PSC symptoms associated with PSC diagnosis
- •Able to speak, read, and understand English
- •Willing and able to provide written informed consent to participate in the research study
排除标准
- •Patients with other causes of liver or biliary disease, including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing cholangitis
- •Patient with history of liver cirrhosis
- •Patients with history of cholangiocarcinoma
- •Patients who have received a liver transplant
- •Patients currently enrolled in PSC clinical trials; and
- •STEP II ONLY: Enrolled in or participated in Step I of this study (concept elicitation)
结局指标
主要结局
List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire
时间窗: Up to 12 months
Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning.
次要结局
未报告次要终点