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NCT Number: NCT04850521

Remote Monitoring of Interstitial Lung Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hampshire Hospitals NHS Foundation Trust, Basingstoke, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote monitoring

Other

patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal

Primary outcomes

  1. Frequency of use ≥3 days/week

    Time frame: 90 days

    Proportion of patients recording measurements ≥3 days/week

  2. Frequency of use on ≥70% of study days

    Time frame: 91 days

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

Secondary outcomes

  1. Health-related quality of life

    Time frame: 91 days

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

  2. Patient engagement

    Time frame: 91 days

    Patient Activation Measure

  3. Change in Forced Vital Capacity (FVC)

    Time frame: 91 days

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

  4. Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)

    Time frame: 91 days

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

  5. Frequency of alert values of pulse oximetry SpO2 per patient

    Time frame: 91 days

    Number of pulse oximetry SpO2 <93% values per patient

  6. Adherence to study measurements

    Time frame: 91 days

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

  7. Frequency of use ≥1 day/week

    Time frame: 91 days

    Proportion of patients recording measurements ≥1 day/week

  8. Frequency of use ≥5 days/week

    Time frame: 91 days

    Proportion of patients recording measurements ≥5 days/week

Other outcomes

  1. Time reviewing remote data

    Time frame: 91 days

    Clinic time reviewing portal data/patient

  2. Clinic/patient contacts

    Time frame: 91 days

    Number of clinic center contacts with patient

  3. Clinic spirometry visits

    Time frame: 91 days

    Number of in-clinic spirometry visits

  4. Hospital admissions

    Time frame: 91 days

    Number of hospital admissions

Sponsors and collaborators

Lead sponsor

patientMpower Ltd.

Industry

Collaborators

  • Innovate UK
  • Quiddity Health Ltd.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 20, 2021
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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