Clinical trial NCT04850521: Remote Monitoring of Interstitial Lung Disease
Official title: Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Lead sponsor: patientMpower Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Quiddity Health Ltd.
name: Innovate UK
First posted: 2021-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed diagnosis of interstitial lung disease (including idiopathic pulmonary fibrosis)

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of use ≥3 days/week
timeFrame: 90 days
measure: Frequency of use on ≥70% of study days
timeFrame: 91 days
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 91 days
measure: Patient engagement
timeFrame: 91 days
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 91 days
measure: Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)
timeFrame: 91 days
measure: Frequency of alert values of pulse oximetry SpO2 per patient
timeFrame: 91 days
measure: Adherence to study measurements
timeFrame: 91 days
measure: Frequency of use ≥1 day/week
timeFrame: 91 days
measure: Frequency of use ≥5 days/week
timeFrame: 91 days
Other outcomes:
measure: Time reviewing remote data
timeFrame: 91 days
measure: Clinic/patient contacts
timeFrame: 91 days
measure: Clinic spirometry visits
timeFrame: 91 days
measure: Hospital admissions
timeFrame: 91 days
Locations:
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College NHS Healthcare Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
Study officials:
References: