Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Home monitoring care.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Fibrosis, Interstitial Lung Disease (ILD). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The SUITS Study: Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
Обзор
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.
Подробное описание
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.
Вмешательства
- Комбинированный продукт 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.
Первичные конечные точки
- Patient self-management [Срок оценки: Baseline to 12 months]
Вторичные конечные точки (12)
- Patient self-management [Срок оценки: Baseline]
- Patient self-management [Срок оценки: Baseline to 6 months]
- Living with Pulmonary Fibrosis (L-PF) questionnaire [Срок оценки: Baseline]
- Living with Pulmonary Fibrosis (L-PF) questionnaire [Срок оценки: Baseline to 6 months]
- Living with Pulmonary Fibrosis (L-PF) questionnaire [Срок оценки: Baseline to 12 months]
- King's brief Interstitial Lung Disease Health Status (K-BILD) [Срок оценки: Baseline]
- King's brief Interstitial Lung Disease Health Status (K-BILD) [Срок оценки: Baseline to 6 months]
- King's brief Interstitial Lung Disease Health Status (K-BILD) [Срок оценки: Baseline to 12 months]
- The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire [Срок оценки: Baseline]
- The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire [Срок оценки: Baseline to 6 months]
- The EuroQol five dimensions 5-level plus respiratory bolt-on (EQ-5D-5L+R) questionnaire [Срок оценки: Baseline to 12 months]
- Scheduled respiratory related outpatient clinic visits [Срок оценки: Baseline to 12 months]
Критерии участия
Критерии включения
- A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
- Adults (=/>18 years).
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Нидерланды · 11 центров
- Department of Pulmonology, Onze Lieve Vrouwe Gasthuis — Amsterdam
- Department of Pulmonary Diseases, Rijnstate Hospital — Arnhem
- Department of Respiratory Medicine, Amphia Hospital — Breda
- Department of Respiratory Medicine, Catharina Hospital — Eindhoven
- Department of Pulmonary Medicine, Zuyderland Medical Centre — Heerlen
- Department of Pulmonology, Medical Center Leeuwarden — Leeuwarden
- Department of Pulmonology, Leiden University Medical Center — Leiden
- Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St Antonius Ho — Nieuwegein
- … и ещё 3 центра
Публикации
- Hofman DE, Moor CC, van Beek FF, Vorselaars ADM, Overbeek MJ, van Doorn-Hogervorst K, Moonen LAA, van der Maten J, Bresser P, Loth DW, Schakenraad E, Kerstens R, van der Wal P, de Mul M, Mostard RLM, Wijsenbeek MS. Design of a randomized controlled trial comparing hybrid care with standard care for people with pulmonary fibrosis. Respir Res. 2026 Jun 17. doi: 10.1186/s12931-026-03716-0. Online ahe PMID 42310732
Идентификаторы
NCT: NCT06883448 · MEC-2024-0045 · 10140292110006