Remote Monitoring of Interstitial Lung Disease

Sponsor
patientMpower Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04850521
Collaborator
Quiddity Health Ltd. (Other), Innovate UK (Other)
60
4
11.1
15
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Remote monitoring

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment
Actual Study Start Date :
Aug 3, 2021
Actual Primary Completion Date :
Jul 7, 2022
Actual Study Completion Date :
Jul 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Remote monitoring

Remote monitoring software + connected devices

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

Outcome Measures

Primary Outcome Measures

  1. Frequency of use ≥3 days/week [90 days]

    Proportion of patients recording measurements ≥3 days/week

  2. Frequency of use on ≥70% of study days [91 days]

    Proportion of patients recording measurements on ≥70% of study days

Secondary Outcome Measures

  1. Health-related quality of life [91 days]

    EuroQol 5-dimension 5-level (EQ-E5-DL) health status

  2. Patient engagement [91 days]

    Patient Activation Measure

  3. Change in Forced Vital Capacity (FVC) [91 days]

    Proportion of patients with ≥10% decreased FVC vs. baseline

  4. Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2) [91 days]

    Proportion of patients with pulse oximetry SpO2 <93% at any time

  5. Frequency of alert values of pulse oximetry SpO2 per patient [91 days]

    Number of pulse oximetry SpO2 <93% values per patient

  6. Adherence to study measurements [91 days]

    Number of days patients record spirometry/number of days in observation period

  7. Frequency of use ≥1 day/week [91 days]

    Proportion of patients recording measurements ≥1 day/week

  8. Frequency of use ≥5 days/week [91 days]

    Proportion of patients recording measurements ≥5 days/week

Other Outcome Measures

  1. Time reviewing remote data [91 days]

    Clinic time reviewing portal data/patient

  2. Clinic/patient contacts [91 days]

    Number of clinic center contacts with patient

  3. Clinic spirometry visits [91 days]

    Number of in-clinic spirometry visits

  4. Hospital admissions [91 days]

    Number of hospital admissions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hampshire Hospitals NHS Foundation Trust Basingstoke United Kingdom
2 Imperial College NHS Healthcare Trust London United Kingdom
3 Nottingham University Hospitals NHS Trust Nottingham United Kingdom
4 Lancashire Teaching Hospitals NHS Foundation Trust Preston United Kingdom

Sponsors and Collaborators

  • patientMpower Ltd.
  • Quiddity Health Ltd.
  • Innovate UK

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
patientMpower Ltd.
ClinicalTrials.gov Identifier:
NCT04850521
Other Study ID Numbers:
  • ILD patientMpower 01
First Posted:
Apr 20, 2021
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022