Remote Monitoring of Interstitial Lung Disease

Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: Remote monitoring

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United Kingdom
  • Basingstoke, United Kingdom
    • Hampshire Hospitals NHS Foundation Trust
  • London, United Kingdom
    • Imperial College NHS Healthcare Trust
  • Nottingham, United Kingdom
    • Nottingham University Hospitals NHS Trust
  • Preston, United Kingdom
    • Lancashire Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of interstitial lung disease (including idiopathic pulmonary fibrosis)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remote monitoring; Remote monitoring software + connected devices	Other: Remote monitoring; patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of use ≥3 days/week	Proportion of patients recording measurements ≥3 days/week	90 days
Frequency of use on ≥70% of study days	Proportion of patients recording measurements on ≥70% of study days	91 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	EuroQol 5-dimension 5-level (EQ-E5-DL) health status	91 days
Patient engagement	Patient Activation Measure	91 days
Change in Forced Vital Capacity (FVC)	Proportion of patients with ≥10% decreased FVC vs. baseline	91 days
Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)	Proportion of patients with pulse oximetry SpO2 <93% at any time	91 days
Frequency of alert values of pulse oximetry SpO2 per patient	Number of pulse oximetry SpO2 <93% values per patient	91 days
Adherence to study measurements	Number of days patients record spirometry/number of days in observation period	91 days
Frequency of use ≥1 day/week	Proportion of patients recording measurements ≥1 day/week	91 days
Frequency of use ≥5 days/week	Proportion of patients recording measurements ≥5 days/week	91 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time reviewing remote data	Clinic time reviewing portal data/patient	91 days
Clinic/patient contacts	Number of clinic center contacts with patient	91 days
Clinic spirometry visits	Number of in-clinic spirometry visits	91 days
Hospital admissions	Number of hospital admissions	91 days

Collaborators and Investigators

• Sponsor: patientMpower Ltd.
• Collaborators: Innovate UK; Quiddity Health Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): July 7, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: ILD patientMpower 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No