Implementation of Home Monitoring in Patients With Pulmonary Fibrosis (SUITS)

Erasmus University

Status: Enrolling

Conditions: Pulmonary Fibrosis; Interstitial Lung Disease (ILD)

Treatments: Combination Product: Home monitoring care

Study type: Interventional

Funder types: Other

Identifiers

NCT06883448

10140292110006 (Other Grant/Funding Number)

MEC-2024-0045

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
• Adults (=/>18 years).

Exclusion criteria

• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Hospital-based care

No Intervention group

Description:

Hospital-based care involves outpatient clinic visits every three months including in-hospital lung function testing.

Home monitoring care

Experimental group

Description:

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.

Treatment:

Combination Product: Home monitoring care