Current Status of Diagnosis, Treatment and Quality of Life for Patients with Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Unmet patient needs
研究概览
简要总结
The goal of this observational study is to explore current status of diagnosis, treatment and quality of life for patients with idiopathic pulmonary fibrosis. It aims to integrate qualitative and quantitative data to describe the distribution of perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis.
Participants will be invited to participate the interview, and answer quantitative survey questions about their quality of life.
详细描述
Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, fibrotic interstitial lung disease of unknown aetiology primarily affecting middle-aged and elderly patients, more men than women. Median survival is 3∼5 years from the time of diagnosis. The prognosis is worse than for most common malignancies. However, patients' experiences, quality of life and needs during the disease course, have not been adequately investigated, which leads a lack of evidence to support the priority of treatment or drug development.
This study plans to conduct an mixed methods research to integrate qualitative and quantitative data to explore the perspective, experience, patient journey, treatment, expectation and quality of life for patients with idiopathic pulmonary fibrosis. For qualitative interview, there are 50 patients with idiopathic pulmonary fibrosis, and 15 physicians will be interviewed. For quantitative survey, there are 245 patients with idiopathic pulmonary fibrosis will be involved.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IPF patients who are diagnosed according to international guidelines.
- •Physicians who are clinical experts with extensive experience in the treatment of IPF.
排除标准
- •The patient is unable to express his/her opinion clearly.
结局指标
主要结局
Unmet patient needs
时间窗: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
Unmet patient needs primarily focus on the unmet clinical demands and expectations of IPF patients regarding their understanding and awareness of the disease, diagnosis, treatment methods, and patient management and care.
Patient journey
时间窗: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey.
The patient journey primarily focuses on the entire process of IPF patients from the discovery of uncomfortable symptoms, diagnosis, and treatment to follow-up. By mapping the patient journey, we can identify the gaps between patients' expected experiences and their actual experiences at each stage, recognize and address common pain points, and gain insights into the value drivers behind patient decisions. This approach helps healthcare institutions to gain frontline perspectives on patient experiences in a timely manner, optimize disease diagnosis and treatment processes, develop scientifically sound treatment plans, and even assist in designing or enhancing mobile healthcare management solutions for patients.
Quality of life
时间窗: At beginning of study to explore by qualitative study, sequentially follow up at 6 month by quantitative survey
Quality of life primarily focuses on the impact of patients' physical and psychological health, as well as symptoms, and impact for their daily lives. Quality of life will be qualitatively deeply explore by interview, and quantitatively survey using EuroQol Five Dimensions Questionnair (EQ-5D) among patients with idiopathic pulmonary fibrosis.
次要结局
未报告次要终点
研究者
Chu Hongling
Principal Investigator
Peking University Third Hospital