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| Name | Class |
|---|---|
| Quiddity Health Ltd. | UNKNOWN |
| Innovate UK | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote monitoring | Remote monitoring software + connected devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote monitoring | Other | patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of use ≥3 days/week | Proportion of patients recording measurements ≥3 days/week | 90 days |
| Frequency of use on ≥70% of study days | Proportion of patients recording measurements on ≥70% of study days | 91 days |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | EuroQol 5-dimension 5-level (EQ-E5-DL) health status | 91 days |
| Patient engagement | Patient Activation Measure |
| Measure | Description | Time Frame |
|---|---|---|
| Time reviewing remote data | Clinic time reviewing portal data/patient | 91 days |
| Clinic/patient contacts | Number of clinic center contacts with patient |
Inclusion Criteria:
Exclusion Criteria:
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Patients with a confirmed diagnosis of interstitial lung disease (including idiopathic pulmonary fibrosis)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hampshire Hospitals NHS Foundation Trust | Basingstoke | United Kingdom | ||||
| Imperial College NHS Healthcare Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38622608 | Derived | Barth S, Edwards C, Saini G, Haider Y, Williams NP, Storrar W, Jenkins G, Stewart I, Wickremasinghe M. Feasibility and acceptability of remotely monitoring spirometry and pulse oximetry as part of interstitial lung disease clinical care: a single arm observational study. Respir Res. 2024 Apr 15;25(1):162. doi: 10.1186/s12931-024-02787-1. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 19, 2022 | |
| Reset | Oct 23, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 19, 2022 | Oct 23, 2023 |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| 91 days |
| Change in Forced Vital Capacity (FVC) | Proportion of patients with ≥10% decreased FVC vs. baseline | 91 days |
| 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 |
| Frequency of alert values of pulse oximetry SpO2 per patient | Number of pulse oximetry SpO2 <93% values per patient | 91 days |
| Adherence to study measurements | Number of days patients record spirometry/number of days in observation period | 91 days |
| Frequency of use ≥1 day/week | Proportion of patients recording measurements ≥1 day/week | 91 days |
| Frequency of use ≥5 days/week | Proportion of patients recording measurements ≥5 days/week | 91 days |
| 91 days |
| Clinic spirometry visits | Number of in-clinic spirometry visits | 91 days |
| Hospital admissions | Number of hospital admissions | 91 days |
| London |
| United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom |
| Lancashire Teaching Hospitals NHS Foundation Trust | Preston | United Kingdom |