The SUITS Study: Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 19
- 主要终点
- Patient self-management
研究概览
简要总结
The objective of this study is to evaluate the impact of structurally replacing half of the outpatient clinic visits for patients with pulmonary fibrosis by home monitoring and video consultations on patient self-management and health(care) outcomes.
详细描述
Patients will be randomly assigned to receive either hospital-based care or a home monitoring program integrated into hospital-based care. Hospital-based care involves outpatient clinic visits every three months including lung function testing. Home monitoring involves weekly measurements of both physiological- and patient reported outcomes (PROs) in a mobile health care application with half of the outpatient clinic visits alternately being replaced by remote video consultations. The home monitoring program includes home spirometry, pulse-oximetry, PROs, video consultations, a medication coach, and an infotheque showing disease-specific information. Questionnaires will be filled out by both study groups at set time points. The total study duration for individual patients will be 12 months.
Trial Registration and Ethics Statement In the Netherlands, clinical trial registration is not mandatory for studies exempt from ethics review. As this study was exempt from ethics review, as approved by the IRB of Erasmus Medical Center in Rotterdam, the Netherlands, the study was not prospectively registered. During the enrollment phase, the study protocol was retrospectively registered on ClinicalTrials.gov to ensure public access to the study protocol and study outcomes. IRB approval was obtained prior to enrollment of the first participant. No changes were made to the IRB-approved study protocol (version 1, 11-01-2024) prior to registration on ClinicalTrials.gov.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Participants, health-care providers, and research staff will not be masked to group allocation.
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
- •A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
- •Adults (=/>18 years).
排除标准
- •Patients who are not able to speak, read and/or write in Dutch;
- •Patients with no access to the internet;
- •Patients with a life expectancy of less than 1 year as determined by the treating healthcare provider;
- •Patients who are or have been using a home monitoring program for PF.
研究组 & 干预措施
Hospital-based care
Hospital-based care involves outpatient clinic visits every three months including in-hospital lung function testing.
Home monitoring care
Patients in the home monitoring group will receive a home spirometer, pulse oximetry meter, and access to a smartphone or tablet app, where they can perform home based measurements weekly and complete PROMs. Furthermore, this app includes disease specific information and allows for direct communication with the hospital via eConsultation. In the home monitoring group, half of the outpatient clinic visits will alternately be replaced by remote visits via video consultation.
干预措施: Home monitoring care (Combination Product)
结局指标
主要结局
Patient self-management
时间窗: Baseline to 12 months
Delta score of the Patient Activation Measure (PAM) questionnaire. The PAM is a 13-item survey assessing levels of patient activation in terms of managing their own health and healthcare. Total score ranges are 0-100, with higher scores indicating greater patient activation.
次要结局
- Respiratory related remote consultations(Baseline to 12 months)
- Respiratory related emergency visits(Baseline to 12 months)
- Correlation and agreement of home measured Forced vital capacity (FVC)(From baseline to 12 months)
- The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire(Baseline to 12 months)
- Patient self-management(Baseline to 6 months)
- Living with Pulmonary Fibrosis (L-PF) questionnaire(Baseline to 12 months)
- King's brief Interstitial Lung Disease Health Status (K-BILD)(Baseline to 12 months)
- Forced vital capacity (FVC)(Baseline to 12 months)
- Patient self-management(Baseline to 6 months)
- Living with Pulmonary Fibrosis (L-PF) questionnaire(Baseline to 12 months)
- King's brief Interstitial Lung Disease Health Status (K-BILD)(Baseline to 12 months)
- The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire(Baseline to 12 months)
- Scheduled respiratory related outpatient clinic visits(Baseline to 12 months)
- Unscheduled respiratory related outpatient clinic visits(Baseline to 12 months)
- Respiratory related hospitalisations(From baseline to 12 months)
- Mortality or lung transplantation(Baseline to 12 months)
- Diffusing capacity of the lung for carbon monoxide (DLCO)(Baseline to 12 months)
- Patient adherence to home monitoring protocol(Baseline to 12 months)
- Patient self-management(Baseline)
- Living with Pulmonary Fibrosis (L-PF) questionnaire(Baseline)
- Diffusing capacity of the lung for carbon monoxide (DLCO)(Baseline to 6 months)
- Living with Pulmonary Fibrosis (L-PF) questionnaire(Baseline to 6 months)
- King's brief Interstitial Lung Disease Health Status (K-BILD)(Baseline)
- King's brief Interstitial Lung Disease Health Status (K-BILD)(Baseline to 6 months)
- The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire(Baseline)
- The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire(Baseline to 6 months)
- Forced vital capacity (FVC)(Baseline)
- Forced vital capacity (FVC)(Baseline to 6 months)
- Diffusing capacity of the lung for carbon monoxide (DLCO)(Baseline)
研究者
Marlies Wijsenbeek
Prof. Dr., MD
Erasmus Medical Center