Remote Monitoring of Interstitial Lung Disease
- Conditions
- Interstitial Lung Disease
- Interventions
- Other: Remote monitoring
- Registration Number
- NCT04850521
- Lead Sponsor
- patientMpower Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Remote monitoring Remote monitoring Remote monitoring software + connected devices
- Primary Outcome Measures
Name Time Method Frequency of use ≥3 days/week 90 days Proportion of patients recording measurements ≥3 days/week
Frequency of use on ≥70% of study days 91 days Proportion of patients recording measurements on ≥70% of study days
- Secondary Outcome Measures
Name Time Method Change in Forced Vital Capacity (FVC) 91 days Proportion of patients with ≥10% decreased FVC vs. baseline
Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2) 91 days Proportion of patients with pulse oximetry SpO2 \<93% at any time
Adherence to study measurements 91 days Number of days patients record spirometry/number of days in observation period
Frequency of use ≥1 day/week 91 days Proportion of patients recording measurements ≥1 day/week
Health-related quality of life 91 days EuroQol 5-dimension 5-level (EQ-E5-DL) health status
Patient engagement 91 days Patient Activation Measure
Frequency of alert values of pulse oximetry SpO2 per patient 91 days Number of pulse oximetry SpO2 \<93% values per patient
Frequency of use ≥5 days/week 91 days Proportion of patients recording measurements ≥5 days/week
Trial Locations
- Locations (4)
Hampshire Hospitals NHS Foundation Trust
🇬🇧Basingstoke, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Imperial College NHS Healthcare Trust
🇬🇧London, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
🇬🇧Preston, United Kingdom