Remote Monitoring of Interstitial Lung Disease
Remote Monitoring of Interstitial Lung Disease to Provide Continuity of Care and Shielding From Risks Associated With In-clinic Assessment
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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Basingstoke, 영국
- Hampshire Hospitals NHS Foundation Trust
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London, 영국
- Imperial College NHS Healthcare Trust
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Nottingham, 영국
- Nottingham University Hospitals NHS Trust
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Preston, 영국
- Lancashire Teaching Hospitals NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Remote monitoring
Remote monitoring software + connected devices
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patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of use ≥3 days/week
기간: 90 days
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Proportion of patients recording measurements ≥3 days/week
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90 days
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Frequency of use on ≥70% of study days
기간: 91 days
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Proportion of patients recording measurements on ≥70% of study days
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91 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health-related quality of life
기간: 91 days
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EuroQol 5-dimension 5-level (EQ-E5-DL) health status
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91 days
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Patient engagement
기간: 91 days
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Patient Activation Measure
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91 days
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Change in Forced Vital Capacity (FVC)
기간: 91 days
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Proportion of patients with ≥10% decreased FVC vs. baseline
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91 days
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Frequency of patients with alert values of pulse oximetry oxygen saturation (SpO2)
기간: 91 days
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Proportion of patients with pulse oximetry SpO2 <93% at any time
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91 days
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Frequency of alert values of pulse oximetry SpO2 per patient
기간: 91 days
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Number of pulse oximetry SpO2 <93% values per patient
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91 days
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Adherence to study measurements
기간: 91 days
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Number of days patients record spirometry/number of days in observation period
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91 days
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Frequency of use ≥1 day/week
기간: 91 days
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Proportion of patients recording measurements ≥1 day/week
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91 days
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Frequency of use ≥5 days/week
기간: 91 days
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Proportion of patients recording measurements ≥5 days/week
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91 days
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time reviewing remote data
기간: 91 days
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Clinic time reviewing portal data/patient
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91 days
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Clinic/patient contacts
기간: 91 days
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Number of clinic center contacts with patient
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91 days
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Clinic spirometry visits
기간: 91 days
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Number of in-clinic spirometry visits
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91 days
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Hospital admissions
기간: 91 days
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Number of hospital admissions
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91 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .