Clinical trial NCT05662124: ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care
Official title: Comparison of Health Outcomes in a Remote Monitoring Programme Versus Usual Care in Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: patientMpower Ltd.
name: Imperial College London
name: University College, London
name: Action for Pulmonary Fibrosis
First posted: 2022-12-22
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Interstitial lung disease (ILD) is a collective term for a group of diseases where the lungs become scarred causing breathlessness.

This research project will assess if remote digital monitoring of frequent spirometry and pulse oximetry can provide an additional way to monitor ILD and provide information to support virtual consultations. Outcomes in the remote monitoring group will be compared with usual care alone over 12 months.

Patients taking part will be randomly allocated to remote digital monitoring or to usual care (with an equal chance of either). Remote monitoring will be performed using an app provided by patientMpower Ltd which patients will be able to download onto a smartphone or tablet. The study team will provide a spirometer and oximeter for patients to measure their lung function (spirometry) and oxygen saturations. These devices link to the app via Bluetooth to record all measurements. Patients will be asked to do these measurements three times a week. Clinical teams will be asked to review all measurements at least once a fortnight.

Health outcomes will be described and compared between the two groups.

Detailed description: This study hopes to understand more about how remote digital monitoring of spirometry and pulse oximetry fits within the clinical care of patients with interstitial lung disease. This study will randomise patients to either remote monitoring or usual care and then collect information about the trajectory of their interstitial lung disease treatment and monitoring for the next 12 months to understand the impact of remote monitoring.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibrotic interstitial lung disease
* Aged at least 18 years
* Owns a smartphone or tablet device
* Has a mobile telephone number, email address and access to the internet at home
* In clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurement
* Intention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 months
* Willing to allow home monitoring of their health including spirometry and pulse oximetry data
* Understands how to use mobile technology (eg. has downloaded and used other "apps" on their mobile device; uses email)
* Demonstrates willingness to measure spirometry and pulse oximetry three times weekly for the duration of the observation period
* Fluent in English language
* Written or electronic informed consent

Exclusion Criteria:

* Unable to fulfil all inclusion criteria
* Cognitive impairment
* History of difficulties performing spirometry at previous clinic testing
* Contraindications to spirometry (for example previous pneumothorax, unstable cardiac status, known aortic or cerebral aneurysm)
* Serious concomitant conditions which place the patient at high risk of respiratory distress making them unsuitable to be managed at home.
* Current or recent (within the last 6 weeks before baseline) participation in another research project

Primary outcomes:
measure: Spirometry availability at clinical review at first and last clinic appointments during the study observation period
timeFrame: 12 months
Secondary outcomes:
measure: Number of clinical reviews per patient
timeFrame: 12 months
measure: Proportion of clinical reviews which are virtual
timeFrame: 12 months
measure: Number of in-clinic lung function appointments per patient
timeFrame: 12 months
measure: Number of patients who have chest CT scans
timeFrame: 12 months
measure: Change in forced vital capacity (FVC)
timeFrame: 12 months
measure: Number of patients with >10% decline in FVC
timeFrame: 12 months
measure: Number of patients starting new treatments for their interstitial lung disease
timeFrame: 12 months
measure: Adherence to study measurements
timeFrame: 12 months
measure: Number of patients recording measurements at least once/week on at least 66% study weeks
timeFrame: 12 months
measure: Number of unscheduled reviews per patient
timeFrame: 12 months
measure: Number of hospital admissions per patient
timeFrame: 12 months
measure: Change in patient recorded dyspnoea (mMRC) score
timeFrame: 12 months
measure: Change in health-related quality of life (EQ-5D-5L) score
timeFrame: 12 months
measure: Change in King's Brief Interstitial Lung Disease (K-BILD) score
timeFrame: 12 months
measure: Change in Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 12 months
measure: Change in Patient Activation Measure (PAM-13)
timeFrame: 12 months
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon University Healthcare NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospital of Leicester NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: St George's University Hospital NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Trust
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital, Royal Wolverhampton NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Melissa Wickremasinghe
role: PRINCIPAL_INVESTIGATOR
References: