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 Type
OBSERVATIONAL
Enrollment
60
patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
Imperial College NHS Healthcare Trust
London, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
Frequency of use ≥3 days/week
Proportion of patients recording measurements ≥3 days/week
Time frame: 90 days
Frequency of use on ≥70% of study days
Proportion of patients recording measurements on ≥70% of study days
Time frame: 91 days
Health-related quality of life
EuroQol 5-dimension 5-level (EQ-E5-DL) health status
Time frame: 91 days
Patient engagement
Patient Activation Measure
Time frame: 91 days
Change in Forced Vital Capacity (FVC)
Proportion of patients with ≥10% decreased FVC vs. baseline
Time frame: 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
Time frame: 91 days
Frequency of alert values of pulse oximetry SpO2 per patient
Number of pulse oximetry SpO2 \<93% values per patient
Time frame: 91 days
Adherence to study measurements
Number of days patients record spirometry/number of days in observation period
Time frame: 91 days
Frequency of use ≥1 day/week
Proportion of patients recording measurements ≥1 day/week
Time frame: 91 days
Frequency of use ≥5 days/week
Proportion of patients recording measurements ≥5 days/week
Time frame: 91 days
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