Remote Evaluation and Surveillance of Patients With Interstitial Lung Disease: Transforming ILD Care Delivery With Remote Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Detection rate of clinically significant ILD events
研究概览
简要总结
The purpose of this interventional study is to identify which combination of remote monitoring devices (e.g. home spirometry, pulse oximetry, scale, ePROs) is the most feasible (as defined by adherence, retention, and data completeness) and acceptable when used for the detection of clinically significant Interstitial Lung Disease events.
详细描述
Participants in this 12-month study will use home-based monitoring tools provided by the study and complete electronic patient-reported outcome (ePRO) questionnaires to help assess changes in health status over time. Study procedures include weekly home spirometry for all participants, with some participants also asked to complete daily pulse oximetry monitoring and/or weekly weight measurements, depending on study assignment. The study includes an initial in-person baseline visit and a final in-person visit at Month 12 at the UCSF Interstitial Lung Disease Clinic at the Parnassus Campus. Follow-up study visits at Months 3, 6, and 9 will be conducted remotely via Zoom. Participants will complete study-related assessments throughout the study period using electronic devices and questionnaires from home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 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
- •age 18 or older
- •English or Spanish speaking
- •have a UCSF diagnosis of one of the major ILD subtypes seen in the ILD Clinic (Idiopathic Pulmonary Fibrosis, Chronic Hypersensitivity Pneumonitis, Connective-tissue disease related ILD, Sarcoidosis, Familial Fibrosis). Languages are limited to those for which both device instructional materials and user support are available (written and video). The ILD diagnosis will be based on multidisciplinary conference review, which is the diagnostic gold standard. We have restricted the ILD subtypes to those for which there is efficacy data for RPM or comparable clinical trajectories, and subtypes that account for >10% of the ILD diagnoses seen at UCSF.
排除标准
- •Patients who are unable provide informed consent for any reason or are acutely ill.
研究组 & 干预措施
Spirometry Only
Participants randomized to Arm 1 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece). Participants will also complete brief symptom questionnaires electronically throughout the study period.
干预措施: Home Monitoring in Patients with f-ILD (Behavioral)
Spirometer and Oximeter
Participants randomized to Arm 2 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece) and will measure oxygen saturation levels daily using a pulse oximeter. Participants will also complete brief electronic symptom questionnaires throughout the study period.
干预措施: Home Monitoring in Patients with f-ILD (Behavioral)
Spirometer and Scale (weight)
Participants randomized to Arm 3 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece) and will measure their weight weekly using the wireless scale provided by the study. Participants will also complete brief electronic symptom questionnaires throughout the study period.
干预措施: Home Monitoring in Patients with f-ILD (Behavioral)
Spirometer, Oximeter, and Scale (weight)
Participants randomized to Arm 4 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece), measure oxygen saturation levels daily using a pulse oximeter, and measure their weight weekly using the wireless scale provided by the study. Participants will also complete brief electronic symptom questionnaires throughout the study period.
干预措施: Home Monitoring in Patients with f-ILD (Behavioral)
结局指标
主要结局
Detection rate of clinically significant ILD events
时间窗: Baseline, Month 12
Measured using a composite endpoint of acute exacerbation, hospitalization, or rapid disease progression, defined as a ≥10% relative decline in FVC over 3 months
Time to detection of first ILD event
时间窗: Baseline, Month 12
Measured using a composite endpoint of acute exacerbation, hospitalization, or rapid disease progression, defined as a ≥10% relative decline in FVC over 3 months.
Adherence
时间窗: 12 months
Adherence to remote monitoring protocol, defined as the proportion of measurements completed \>=67% of weeks with full data entry)
Retention
时间窗: 12 months
Primary: Participant retention at 12 months (target \>=80%)
Data Completeness
时间窗: 12 months
Data completeness, defined as \>85% of expected remote monitoring data points successfully transmitted
次要结局
- Change in health-related quality of life(Baseline, Month 12)
- Change in FVC(Baseline, Month 12)
- Proportion of patients with ≥10% decline in FVC(Baseline, Month 12)
- Proportion of patients with a change in ILD-related treatment(Baseline, Month 12)
- Patient Engagement and Activation(12 months)
- Patient-reported Satisfaction(12 months)
- Total implementation cost of home monitoring intervention components (per-patient, US dollars)(12 month)
- Unintended Implementation Impact(12 month)
研究者
Erica Farrand, MD
PI
University of California, San Francisco