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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Basingstoke、イギリス
- Hampshire Hospitals NHS Foundation Trust
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London、イギリス
- Imperial College NHS Healthcare Trust
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Nottingham、イギリス
- Nottingham University Hospitals NHS Trust
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Preston、イギリス
- Lancashire Teaching Hospitals NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Frequency of use ≥3 days/week
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Health-related quality of life
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：91 days
|
Proportion of patients recording measurements ≥5 days/week
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91 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time reviewing remote data
時間枠：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
時間枠：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
時間枠：91 days
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Number of in-clinic spirometry visits
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91 days
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Hospital admissions
時間枠：91 days
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Number of hospital admissions
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91 days
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
間質性肺疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
Remote monitoringの臨床試験
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Oslo University HospitalUniversity Hospital of North Norway積極的、募集していない
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Royal Brompton & Harefield NHS Foundation TrustUniversity of Oxford; National Institute for Health Research, United Kingdom完了
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University of AarhusOdense University Hospital; Aarhus University Hospital; Protac A/S; Innovation Fund Denmark募集