Remote Monitoring of Interstitial Lung Disease

NCT04850521 | Completed

• 1 other identifier: ILD patientMpower 01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Health-related quality of life

  91 days

• Patient engagement

  91 days

• Change in Forced Vital Capacity (FVC)

  91 days

• Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)

  91 days

• Frequency of alert values of pulse oximetry SpO2 per patient

  91 days

Other Outcomes (4)

• Time reviewing remote data

  91 days

• Clinic/patient contacts

  91 days

• Clinic spirometry visits

  91 days

Study Arms (1)

Remote monitoring

Remote monitoring software + connected devices

Other: Remote monitoring

Interventions

Remote monitoring OTHER

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

Remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• patientMpower Ltd.: lead
• Quiddity Health Ltd.: collaborator
• Innovate UK: collaborator

Study Sites (4)

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

Location

Imperial College NHS Healthcare Trust

London, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Location

Related Publications (1)

• Barth S, Edwards C, Saini G, Haider Y, Williams NP, Storrar W, Jenkins G, Stewart I, Wickremasinghe M. Feasibility and acceptability of remotely monitoring spirometry and pulse oximetry as part of interstitial lung disease clinical care: a single arm observational study. Respir Res. 2024 Apr 15;25(1):162. doi: 10.1186/s12931-024-02787-1.

  PMID: 38622608 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: August 3, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

GB (4)