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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Basingstoke, Det Forenede Kongerige
- Hampshire Hospitals NHS Foundation Trust
-
London, Det Forenede Kongerige
- Imperial College NHS Healthcare Trust
-
Nottingham, Det Forenede Kongerige
- Nottingham University Hospitals NHS Trust
-
Preston, Det Forenede Kongerige
- Lancashire Teaching Hospitals NHS Foundation Trust
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Remote monitoring
Remote monitoring software + connected devices
|
patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of use ≥3 days/week
Tidsramme: 90 days
|
Proportion of patients recording measurements ≥3 days/week
|
90 days
|
|
Frequency of use on ≥70% of study days
Tidsramme: 91 days
|
Proportion of patients recording measurements on ≥70% of study days
|
91 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health-related quality of life
Tidsramme: 91 days
|
EuroQol 5-dimension 5-level (EQ-E5-DL) health status
|
91 days
|
|
Patient engagement
Tidsramme: 91 days
|
Patient Activation Measure
|
91 days
|
|
Change in Forced Vital Capacity (FVC)
Tidsramme: 91 days
|
Proportion of patients with ≥10% decreased FVC vs. baseline
|
91 days
|
|
Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)
Tidsramme: 91 days
|
Proportion of patients with pulse oximetry SpO2 <93% at any time
|
91 days
|
|
Frequency of alert values of pulse oximetry SpO2 per patient
Tidsramme: 91 days
|
Number of pulse oximetry SpO2 <93% values per patient
|
91 days
|
|
Adherence to study measurements
Tidsramme: 91 days
|
Number of days patients record spirometry/number of days in observation period
|
91 days
|
|
Frequency of use ≥1 day/week
Tidsramme: 91 days
|
Proportion of patients recording measurements ≥1 day/week
|
91 days
|
|
Frequency of use ≥5 days/week
Tidsramme: 91 days
|
Proportion of patients recording measurements ≥5 days/week
|
91 days
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time reviewing remote data
Tidsramme: 91 days
|
Clinic time reviewing portal data/patient
|
91 days
|
|
Clinic/patient contacts
Tidsramme: 91 days
|
Number of clinic center contacts with patient
|
91 days
|
|
Clinic spirometry visits
Tidsramme: 91 days
|
Number of in-clinic spirometry visits
|
91 days
|
|
Hospital admissions
Tidsramme: 91 days
|
Number of hospital admissions
|
91 days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ILD patientMpower 01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .