Remote monitoring
Otherpatient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
NCT Number: NCT04850521
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.
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Notify Me18 year and older
All sexes
Observational
Hampshire Hospitals NHS Foundation Trust, Basingstoke, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
Time frame: 90 days
Proportion of patients recording measurements ≥3 days/week
Time frame: 91 days
Proportion of patients recording measurements on ≥70% of study days
Time frame: 91 days
EuroQol 5-dimension 5-level (EQ-E5-DL) health status
Time frame: 91 days
Patient Activation Measure
Time frame: 91 days
Proportion of patients with ≥10% decreased FVC vs. baseline
Time frame: 91 days
Proportion of patients with pulse oximetry SpO2 <93% at any time
Time frame: 91 days
Number of pulse oximetry SpO2 <93% values per patient
Time frame: 91 days
Number of days patients record spirometry/number of days in observation period
Time frame: 91 days
Proportion of patients recording measurements ≥1 day/week
Time frame: 91 days
Proportion of patients recording measurements ≥5 days/week
Time frame: 91 days
Clinic time reviewing portal data/patient
Time frame: 91 days
Number of clinic center contacts with patient
Time frame: 91 days
Number of in-clinic spirometry visits
Time frame: 91 days
Number of hospital admissions
patientMpower Ltd.
Industry
Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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