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Remote Monitoring of Interstitial Lung Disease

NCT04850521 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-07-12

No results posted yet for this study

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

Interventions

OTHER

Remote monitoring

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

Sponsors & Collaborators

  • Quiddity Health Ltd.

    collaborator UNKNOWN

  • Innovate UK

    collaborator OTHER_GOV

  • patientMpower Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2022-07-07
Completion
2022-07-07

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04850521 on ClinicalTrials.gov