Remote Monitoring of Interstitial Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-03

Study Completion Date

2022-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

As in-clinic pulmonary function testing is greatly restricted due to Coronavirus Disease 2019 (COVID19), alternative approaches to monitoring patients with long-term respiratory conditions need to be developed and assessed. This project will evaluate the feasibility of a remote monitoring programme designed for interstitial lung disease (ILD) \[including idiopathic pulmonary fibrosis (IPF)\] patients which includes patient-reported spirometry \& pulse oximetry (to estimate lung airflow and oxygen levels in the blood).

Patients with a confirmed diagnosis of ILD will be asked to measure spirometry \& pulse oximetry once/day for approximately three months. Each patient will be supplied with a spirometer \& pulse oximeter for home use. There will be no other changes to patients' care. The clinical teams responsible for care of the patients will be able to view all patient-recorded data immediately after data are recorded by the patient. Feasibility of remote monitoring will be assessed by determining the proportion of patients who provide measurements at least 3 times/week and on at least 70% of days in the observation period. Patient engagement (Patient Activation Measure), changes in spirometry measurements over time and healthcare resource utilisation (e.g. number of in-clinic visits) will also be assessed. Other outcomes assessed will include estimation of the proportion of patients with significant decreases in lung function, number of occasions where critical alert values of physiological parameters are reported and number of interventions by healthcare professionals in response to observations or alerts from remote monitoring. Feedback from patients and healthcare providers on user experience will also be sought.

Learnings from this project will be used to assess the wider application of delivery of digitally-based remote monitoring in management of long-term respiratory conditions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

NCT05662124

Interstitial Lung Disease

ACTIVE_NOT_RECRUITING NA

The UK Interstitial Lung Disease Long-COVID19 Study (UKILD-Long COVID): Understanding the Burden of Interstitial Lung Disease in Long COVID.

NCT05514522

Interstitial Lung Disease SARS-CoV-2 Infection

RECRUITING

Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis

NCT03104322

Idiopathic Pulmonary Fibrosis

COMPLETED NA

Integrating Molecular, Genomic, Morphology and Environmental Features to Improve Precision Diagnosis and Treatment in Interstitial Lung Diseases (PRECISION-ILD)

NCT05998512

Interstitial Lung Disease Interstitial Fibrosis

RECRUITING

Self-monitoring of Spirometry & Symptoms Via patientMpower App in Idiopathic Pulmonary Fibrosis

NCT03744598

Idiopathic Pulmonary Fibrosis

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interstitial Lung Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remote monitoring

Remote monitoring software + connected devices

Remote monitoring

Intervention Type OTHER

patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remote monitoring

patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* diagnosis of interstitial lung disease
* Forced Vital Capacity ≥50% predicted (at most recent in-clinic spirometry test)
* owns a smartphone or tablet device
* has a mobile telephone number, email address and access to internet at home
* willing to allow home monitoring of their health including spirometry and pulse oximetry data
* understands how to use mobile technology (e.g. has downloaded and used other "apps" on their mobile device; uses email)
* demonstrates willingness to measure spirometry and pulse oximetry daily for the duration of the study
* fluent in English language
* Written informed consent.

Exclusion Criteria

* serious concomitant conditions which place the patient at high risk of respiratory distress, making them unsuitable to be managed at home
* confusion which would limit the patient's understanding of the project or the measurement procedures
* current or recent (within last 6 weeks before baseline) participation in another clinical research project.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No