Remote Monitoring of Interstitial Lung Disease

patientMpower

Status: Completed

Conditions: Interstitial Lung Disease

Treatments: Other: Remote monitoring

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04850521

ILD patientMpower 01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Remote monitoring

Description:

Remote monitoring software + connected devices

Treatment:

Other: Remote monitoring