An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology: I-FILE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The I-FILE study is a prospective multicenter, multinational observational study where the feasibility of a patient-led registry using home monitoring in patients with pulmonary fibrosis will be evaluated. The aim of the study is to gain more insights in disease behavior in patients with pulmonary fibrosis, so in future patients with progressive disease can be better identified.
详细描述
Nowadays, identifying disease progression will have direct treatment implications in patients with fibrotic Interstitial lung diseases (F-ILDs). eHealth could be a possible solution for close monitoring and detecting disease progression, at a low burden for patients and healthcare providers. The main aim of the I-FILE study will be to evaluate feasibility of a patient-led registry using home spirometry to monitor disease progression in patients with F-ILD. The secondary aim will be to better validate existing health-related quality of life questionnaires to assess the impact of disease and treatment in these patients.
In total 500 patients with newly diagnosed F-ILD will be included. Patients will perform daily home spirometry in the first three months followed by once weekly measurements with a follow up period of 2 years. In addition, patient-reported outcomes (PROMs) will be completed online every 6 months. Results are encrypted and directly sent to a secured server through the online I-FILE application.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Newly diagnosed patients with F-ILD according to the ATS/ERS criteria by a multidisciplinary ILD team :
- •MDT diagnosis ≤ 6 months before inclusion
- •Treatment for F-ILD ≤ than 1 month
排除标准
- •Not able to speak, read or write in the native language of the country where the patient is included
- •Not able to comply to the study protocol, according to the judgement of the investigator and/or patient
- •No access to internet
结局指标
主要结局
Mortality
时间窗: 2 years
Mortality
Forced Vital Capacity (FVC) home spirometry
时间窗: 24 months after inclusion
FVC change measured with home spirometry and saturation at 24 months (in % and L)
WPAI
时间窗: After 24 months
• Work Productivity and Activity Impairment Questionnaire: General Health (WPAI) All patients in the working age population will complete this questionnaire which assess loss of work productivity due to disease in six questions .It will take about 2-3 minutes to complete. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
GRoC
时间窗: After 24 months
• Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
Time to change of VAS
时间窗: 2 years
• Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
Adherence to weekly home spirometry
时间窗: 2 years after inclusion
The percentage of patients completed weekly home spirometry
L-PF Impacts
时间窗: After 24 months
• Living with Pulmonary Fibrosis: 21-item questionnaire which assess the way pulmonary fibrosis has impact on quality of life. Total scores range from 0-4, with a higher score indicating more impact of lung fibrosis on the quality of life.
VAS
时间窗: After 24 months
• Visual Analogue Scale: scores on fatigue, dyspnea, cough and general wellbeing on a scale ranging from 0-10. Higher score indicates more complaint.
K-BILD
时间窗: After 24 months
• King's brief Interstitial Lung Disease Health Status: The K-BILD health status questionnaire is a 15 item validated, self-completed heath status questionnaire. It has three domains: breathlessness and activities, psychological and chest symptoms. The K-BILD domain and total score ranges are 0-100, with the higher scores corresponding with better HRQOL. It will take about 3 minutes to complete this questionnaire.
EQ5D
时间窗: After 24 months
• The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status.
FAS
时间窗: After 24 months
• Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Time to change of K-BILD
时间窗: 2 years
• King's brief Interstitial Lung Disease Health Status: The K-BILD health status questionnaire is a 15 item validated, self-completed heath status questionnaire. It has three domains: breathlessness and activities, psychological and chest symptoms. The K-BILD domain and total score ranges are 0-100, with the higher scores corresponding with better HRQOL. It will take about 3 minutes to complete this questionnaire.
Forced Vital Capacity (FVC) hospital spirometry
时间窗: 24 months after inclusion
FVC change measured with hospital spirometry and saturation at 24 months (in % and L)
Adherence to daily home spirometry
时间窗: 3 months after inclusion
The percentage of patients completed daily home spirometry
Time to change of L-PF Impacts
时间窗: 2 years
• Living with Pulmonary Fibrosis: 21-item questionnaire which assess the way pulmonary fibrosis has impact on quality of life. Total scores range from 0-4, with a higher score indicating more impact of lung fibrosis on the quality of life.
Time to change of WPAI
时间窗: 2 years
• Work Productivity and Activity Impairment Questionnaire: General Health (WPAI) All patients in the working age population will complete this questionnaire which assess loss of work productivity due to disease in six questions .It will take about 2-3 minutes to complete. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
LCQ
时间窗: After 24 months
• Leicester Cough Questionnaire: Cough-specific, health related quality of life is assessed with the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire that has been validated in acute and chronic cough. The overall score ranges from 3 to 21 with a higher score indicating a better quality of life. It will take about 4 minutes to complete the questionnaire.
Healthcare provider and patient satisfaction
时间窗: 2 years
Healthcare provider and patient satisfaction and experience with the online application. Patients and healthcare providers are asked about their experiences and opinions on homemonitoring.
Time to change of GRoC
时间窗: 2 years
• Global Rating of Change Scales: Global rating of change (GRC) scales provide a method of obtaining information about improving or deteriorated of health condition of patients over time. Patients are asked to make global ratings on changes in regards to their well-being on a 15-point self-report scale (from -7 to 7 ). It will take about 1 minute to complete. Higher score indicates a better health condition.
FVC change and HRQOL and symptom changes
时间窗: 24 months
Correlations between FVC change and HRQOL and symptom changes
Time to change of EQ5D
时间窗: 2 years
• The EuroQol five dimensions 5-level questionnaire: 6-item questionnaire on five dimensions: The EuroQol five dimensions 5-level questionnaire is a standardized instrument to measures health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher score indicates a poorer health status.
Time to change of LCQ
时间窗: 2 years
• Leicester Cough Questionnaire: Cough-specific, health related quality of life is assessed with the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire that has been validated in acute and chronic cough. The overall score ranges from 3 to 21 with a higher score indicating a better quality of life. It will take about 4 minutes to complete the questionnaire.
Time to change of FAS
时间窗: 2 years
• Fatigue Assessment Scale: 10-item questionnaire about fatigue FAS. The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The minimal important difference (MID) is 4 points or a 10% lower score. It will take about 1-2 minutes to complete.
Predictors
时间窗: 2 years
Predictors of disease progression and mortality
FVC change hospital-based and home spirometry
时间窗: 2 years
Correlations between FVC change between home and hospital-based spirometry
Differences in adherence between countries
时间窗: 2 years
Differences in adherence, FVC change, HRQOL and mortality between countries
次要结局
未报告次要终点
研究者
Marlies Wijsenbeek
Principal investigator
Erasmus Medical Center