Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Assess the change in coping skills for patients with IPF before and after a comprehensive pulmonary rehabilitation program.
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF), a chronic fibrotic lung disease of unknown cause, is characterized by relentless progression, with a three-year mortality of up to 50%. IPF has high morbidity, with 90% of patients reporting dyspnea at the time of diagnosis and this is strongly correlated with quality of life and mortality. As IPF progress, breathlessness worsens, physical functional capacity declines, and health-related quality of life deteriorates. Pulmonary rehabilitation (PR) can improve well-being in patients with other chronic lung disease, but little is known regarding PR in IPF.
详细描述
The hypothesis is that the provision of a comprehensive pulmonary rehabilitation program to patients with IPF will significantly improve participant health related quality of life. The objective is to develop a comprehensive, multi-disciplinary 12-week PR program with disease specific educational components for IPF patients. The specific aims of the proposal is to evaluate the effect of the comprehensive PR program on 1) improvements in quality of life using the Medical Outcomes Study 36-Item Short Form 36 (SF-36), a quality of life instrument and 2) improvements in patient self-reported dyspnea scores using the chronic respiratory questionnaire. The investigator intends to evaluate sustained benefits of the PR intervention, changes in depression, anxiety, stress and functional physical capacity.
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
- •Diagnosis of IPF confirmed by lung biopsy or by characteristic pattern on high resolution computed tomogram (HRCT)
- •No identifiable cause of lung fibrosis
- •PR not received in the past year
- •Ability to walk
排除标准
- •History of unstable angina
- •Deterioration cardiac or neurological disease
- •Pregnancy or lactation
- •Degenerative arthritis or other limitation to mobility
- •PR in the past 12 months
研究组 & 干预措施
Single Arm
This project is being withdrawn. No revisions to ARM is available.
Patients will undergo consultation and education by members of a pre-determined multi-disciplinary team that aims to bring a predetermined set of services to the patient in a coordinated and scheduled manner in order to facilitate a comprehensive and through approach to the patient's entire well being
干预措施: Multi-Disciplinary Patient Centered Rehab and Education (Other)
结局指标
主要结局
Assess the change in coping skills for patients with IPF before and after a comprehensive pulmonary rehabilitation program.
时间窗: 12 months
This project is being withdrawn. No revisions to Outcomes is available. Will use COPE questionnaire.
Assess the change in depression, anxiety for patients with IPF before and after a comprehensive pulmonary rehabilitation program.
时间窗: 12 months
Will use DASS-21 questionnaire.
Assess the change in quality of life for patients with IPF before and after a comprehensive pulmonary rehabilitation program.
时间窗: 12 months
Will use 36-item SF questionnaire.
次要结局
未报告次要终点
研究者
Vijaya Ramalingam
Assistant Professor of Medicine
Medical College of Wisconsin