Back to resultsILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care (REMOTE-ILD)
Primary Purpose
Interstitial Lung Disease
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Remote monitoring
Sponsored by
About this trial
This is an interventional other trial for Interstitial Lung Disease
Eligibility Criteria
Inclusion Criteria: Diagnosis of fibrotic interstitial lung disease Aged at least 18 years Owns a smartphone or tablet device Has a mobile telephone number, email address and access to the internet at home In clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurement Intention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 months Willing to allow home monitoring of their health including spirometry and pulse oximetry data Understands how to use mobile technology (eg. has downloaded and used other "apps" on their mobile device; uses email) Demonstrates willingness to measure spirometry and pulse oximetry three times weekly for the duration of the observation period Fluent in English language Written or electronic informed consent Exclusion Criteria: Unable to fulfil all inclusion criteria Cognitive impairment History of difficulties performing spirometry at previous clinic testing Contraindications to spirometry (for example previous pneumothorax, unstable cardiac status, known aortic or cerebral aneurysm) Serious concomitant conditions which place the patient at high risk of respiratory distress making them unsuitable to be managed at home. Current or recent (within the last 6 weeks before baseline) participation in another research project
Sites / Locations
- Royal Devon University Healthcare NHS Trust
- University Hospital of Leicester NHS TrustRecruiting
- Imperial College Healthcare NHS TrustRecruiting
- Royal Brompton HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Remote Monitoring
Usual Care
Arm Description
Patients in this arm will be asked to record their spirometry and oximetry three times weekly. This will be performed using a spirometer and oximeter which upload the results via bluetooth to the patientMpower app on their smartphones/tablets. These results are immediately available for review by their clinical teams who will be asked to review them at least once a fortnight. All patients will be asked to complete surveys at baseline, 3, 6, and 12 months and for clinical outcome data during the observation period to be collected.
Patients in this arm will undergo usual clinical care as planned by their medical team. They will be asked to complete surveys at baseline, 3,6 and 12 months and for clinical outcome data during the observation period to be collected.
Outcomes
Primary Outcome Measures
Spirometry availability at clinical review
Number of patients who have spirometry recorded with the preceding 2 weeks for review at the first and last clinical reviews during the observation period
Secondary Outcome Measures
Number of clinical reviews per patient
Average for each arm
Proportion of clinical reviews which are virtual
Average for each arm
Number of in-clinic lung function appointments per patient
Average for each arm
Number of patients who have chest CT scans
Change in forced vital capacity (FVC)
Average for each arm
Number of patients with >10% decline in FVC
Number of patients starting new treatments for their interstitial lung disease
Adherence to study measurements
Active arm only, adherence calculated as number of days with recordings/156 days, result will be an average.
Number of patients recording measurements at least once/week on > or equal to 66% study weeks
active arm only.
Number of unscheduled reviews per patient
Average for each arm
Number of hospital admissions per patient
Average for each arm
Full Information
NCT ID
NCT05662124
First Posted
December 14, 2022
Last Updated
August 3, 2023
Sponsor
Imperial College Healthcare NHS Trust
Collaborators
patientMpower Ltd., Imperial College London, University College, London, Action for Pulmonary Fibrosis
1. Study Identification
Unique Protocol Identification Number
NCT05662124
Brief Title
ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care
Acronym
REMOTE-ILD
Official Title
Comparison of Health Outcomes in a Remote Monitoring Programme Versus Usual Care in Interstitial Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust
Collaborators
patientMpower Ltd., Imperial College London, University College, London, Action for Pulmonary Fibrosis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Interstitial lung disease (ILD) is a collective term for a group of diseases where the lungs become scarred causing breathlessness.
This research project will assess if remote digital monitoring of frequent spirometry and pulse oximetry can provide an additional way to monitor ILD and provide information to support virtual consultations. Outcomes in the remote monitoring group will be compared with usual care alone over 12 months.
Patients taking part will be randomly allocated to remote digital monitoring or to usual care (with an equal chance of either). Remote monitoring will be performed using an app provided by patientMpower Ltd which patients will be able to download onto a smartphone or tablet. The study team will provide a spirometer and oximeter for patients to measure their lung function (spirometry) and oxygen saturations. These devices link to the app via Bluetooth to record all measurements. Patients will be asked to do these measurements three times a week. Clinical teams will be asked to review all measurements at least once a fortnight.
Health outcomes will be described and compared between the two groups.
Detailed Description
This study hopes to understand more about how remote digital monitoring of spirometry and pulse oximetry fits within the clinical care of patients with interstitial lung disease. This study will randomise patients to either remote monitoring or usual care and then collect information about the trajectory of their interstitial lung disease treatment and monitoring for the next 12 months to understand the impact of remote monitoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote Monitoring
Arm Type
Experimental
Arm Description
Patients in this arm will be asked to record their spirometry and oximetry three times weekly. This will be performed using a spirometer and oximeter which upload the results via bluetooth to the patientMpower app on their smartphones/tablets. These results are immediately available for review by their clinical teams who will be asked to review them at least once a fortnight.
All patients will be asked to complete surveys at baseline, 3, 6, and 12 months and for clinical outcome data during the observation period to be collected.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in this arm will undergo usual clinical care as planned by their medical team. They will be asked to complete surveys at baseline, 3,6 and 12 months and for clinical outcome data during the observation period to be collected.
Intervention Type
Other
Intervention Name(s)
Remote monitoring
Other Intervention Name(s)
patientMpower app
Intervention Description
Patients will download the patientMpower app and be provided with a spirometer (Spirobank Smart, MIR) and oximeter (Nonin) to record their spirometry and pulse oximetry which will upload to the application via Bluetooth for clinical review.
Patients will be asked to upload measurements three times per week.
Primary Outcome Measure Information:
Title
Spirometry availability at clinical review
Description
Number of patients who have spirometry recorded with the preceding 2 weeks for review at the first and last clinical reviews during the observation period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of clinical reviews per patient
Description
Average for each arm
Time Frame
12 months
Title
Proportion of clinical reviews which are virtual
Description
Average for each arm
Time Frame
12 months
Title
Number of in-clinic lung function appointments per patient
Description
Average for each arm
Time Frame
12 months
Title
Number of patients who have chest CT scans
Time Frame
12 months
Title
Change in forced vital capacity (FVC)
Description
Average for each arm
Time Frame
12 months
Title
Number of patients with >10% decline in FVC
Time Frame
12 months
Title
Number of patients starting new treatments for their interstitial lung disease
Time Frame
12 months
Title
Adherence to study measurements
Description
Active arm only, adherence calculated as number of days with recordings/156 days, result will be an average.
Time Frame
12 months
Title
Number of patients recording measurements at least once/week on > or equal to 66% study weeks
Description
active arm only.
Time Frame
12 months
Title
Number of unscheduled reviews per patient
Description
Average for each arm
Time Frame
12 months
Title
Number of hospital admissions per patient
Description
Average for each arm
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of fibrotic interstitial lung disease
Aged at least 18 years
Owns a smartphone or tablet device
Has a mobile telephone number, email address and access to the internet at home
In clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurement
Intention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 months
Willing to allow home monitoring of their health including spirometry and pulse oximetry data
Understands how to use mobile technology (eg. has downloaded and used other "apps" on their mobile device; uses email)
Demonstrates willingness to measure spirometry and pulse oximetry three times weekly for the duration of the observation period
Fluent in English language
Written or electronic informed consent
Exclusion Criteria:
Unable to fulfil all inclusion criteria
Cognitive impairment
History of difficulties performing spirometry at previous clinic testing
Contraindications to spirometry (for example previous pneumothorax, unstable cardiac status, known aortic or cerebral aneurysm)
Serious concomitant conditions which place the patient at high risk of respiratory distress making them unsuitable to be managed at home.
Current or recent (within the last 6 weeks before baseline) participation in another research project
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Barth
Phone
+44 7435870022
Email
imperial.ildmonitoring@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Wickremasinghe
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Devon University Healthcare NHS Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Seath
Phone
01392406981
Email
ingrid.seath@nhs.net
Facility Name
University Hospital of Leicester NHS Trust
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
amanda.charalambou@uhl-tr.nhs.uk
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Email
imperial.ildmonitoring@nhs.net
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
020 7352 8121
Email
R.ILD@rbht.nhs.uk
First Name & Middle Initial & Last Name & Degree
Philip Molyneaux
12. IPD Sharing Statement
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ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care
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