Remote Monitoring of Interstitial Lung Disease
Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Basingstoke, Regno Unito
- Hampshire Hospitals NHS Foundation Trust
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London, Regno Unito
- Imperial College NHS Healthcare Trust
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Nottingham, Regno Unito
- Nottingham University Hospitals NHS Trust
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Preston, Regno Unito
- Lancashire Teaching Hospitals NHS Foundation Trust
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Remote monitoring
Remote monitoring software + connected devices
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patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Frequency of use ≥3 days/week
Lasso di tempo: 90 days
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Proportion of patients recording measurements ≥3 days/week
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90 days
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Frequency of use on ≥70% of study days
Lasso di tempo: 91 days
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Proportion of patients recording measurements on ≥70% of study days
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91 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Health-related quality of life
Lasso di tempo: 91 days
|
EuroQol 5-dimension 5-level (EQ-E5-DL) health status
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91 days
|
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Patient engagement
Lasso di tempo: 91 days
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Patient Activation Measure
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91 days
|
|
Change in Forced Vital Capacity (FVC)
Lasso di tempo: 91 days
|
Proportion of patients with ≥10% decreased FVC vs. baseline
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91 days
|
|
Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)
Lasso di tempo: 91 days
|
Proportion of patients with pulse oximetry SpO2 <93% at any time
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91 days
|
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Frequency of alert values of pulse oximetry SpO2 per patient
Lasso di tempo: 91 days
|
Number of pulse oximetry SpO2 <93% values per patient
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91 days
|
|
Adherence to study measurements
Lasso di tempo: 91 days
|
Number of days patients record spirometry/number of days in observation period
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91 days
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Frequency of use ≥1 day/week
Lasso di tempo: 91 days
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Proportion of patients recording measurements ≥1 day/week
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91 days
|
|
Frequency of use ≥5 days/week
Lasso di tempo: 91 days
|
Proportion of patients recording measurements ≥5 days/week
|
91 days
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time reviewing remote data
Lasso di tempo: 91 days
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Clinic time reviewing portal data/patient
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91 days
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Clinic/patient contacts
Lasso di tempo: 91 days
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Number of clinic center contacts with patient
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91 days
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Clinic spirometry visits
Lasso di tempo: 91 days
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Number of in-clinic spirometry visits
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91 days
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Hospital admissions
Lasso di tempo: 91 days
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Number of hospital admissions
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91 days
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ILD patientMpower 01
Informazioni su farmaci e dispositivi, documenti di studio
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