Remote Monitoring of Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

Official title:

Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850521
• Other study ID #: ILD patientMpower 01
• Status: Completed
• Start date: August 3, 2021
• Est. completion date: July 7, 2022

Study information

• Verified date: July 2022
• Source: patientMpower Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Remote monitoring
patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
patientMpower Ltd.	Innovate UK, Quiddity Health Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time reviewing remote data	Clinic time reviewing portal data/patient	91 days
Other	Clinic/patient contacts	Number of clinic center contacts with patient	91 days
Other	Clinic spirometry visits	Number of in-clinic spirometry visits	91 days
Other	Hospital admissions	Number of hospital admissions	91 days
Primary	Frequency of use =3 days/week	Proportion of patients recording measurements =3 days/week	90 days
Primary	Frequency of use on =70% of study days	Proportion of patients recording measurements on =70% of study days	91 days
Secondary	Health-related quality of life	EuroQol 5-dimension 5-level (EQ-E5-DL) health status	91 days
Secondary	Patient engagement	Patient Activation Measure	91 days
Secondary	Change in Forced Vital Capacity (FVC)	Proportion of patients with =10% decreased FVC vs. baseline	91 days
Secondary	Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)	Proportion of patients with pulse oximetry SpO2 <93% at any time	91 days
Secondary	Frequency of alert values of pulse oximetry SpO2 per patient	Number of pulse oximetry SpO2 <93% values per patient	91 days
Secondary	Adherence to study measurements	Number of days patients record spirometry/number of days in observation period	91 days
Secondary	Frequency of use =1 day/week	Proportion of patients recording measurements =1 day/week	91 days
Secondary	Frequency of use =5 days/week	Proportion of patients recording measurements =5 days/week	91 days