NoRCoRP Assessment Clinic (NoRCoRP)
The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
調査の概要
状態
条件
詳細な説明
The severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2 / COVID-19) pandemic, has affected over 13 million people, and caused significant worldwide mortality and morbidity. Frequent long-term respiratory complications include persistent breathlessness and fatigue, with potential for ongoing organising pneumonia and new pulmonary fibrosis as well as thromboembolic disease. Additional features seen in at least some patients post hospital include impaired musculoskeletal function, impaired renal function, neurological impairment, cardiac dysfunction and significant psychiatric morbidity.
The majority of patients with COVID-19 were not admitted to hospital, and the longer-term consequences of infection with SARS-CoV-2 in this much larger patient group are unknown. Whilst many patients had relatively mild disease and made a good recovery, a significant number have been left with symptoms similar to those who were admitted to hospital.
In setting up a post COVID-19 respiratory review clinic, we expect to generate new findings, support studies that have already been submitted for funding, to provide a focus for further grant funding, and to provide an infrastructure to support new clinical trials. We also expect the insights gained from research using this platform to be of value for service planning in the region and beyond. We will prioritise patients who were not admitted to hospital but who have been left with significant morbidity by establishing this new General Practitioner (GP) referral research clinic.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Charlotte Bolton
- 電話番号:54844 01159 691169
- メール:charlotte.bolton@nottingham.ac.uk
研究連絡先のバックアップ
- 名前:Alex Jenkins
- メール:alex.jenkins@nottingham.ac.uk
研究場所
-
-
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Nottingham、イギリス、NG5 1PB
- 募集
- Nottingham City Hospital
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コンタクト:
- Charlotte Bolton
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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:
- Adults (≥18 years) referred into the post COVID-19 respiratory outpatient clinic from primary care, following a swab, imaging or strong clinical diagnosis of COVID-19
- Adults discharged from hospital with a clinical diagnosis of COVID-19 (who are not included in the PHOSP-COVID study)
Exclusion Criteria:
- Children (<18 years) referred into the post COVID-19 respiratory outpatient clinic. This clinic is only open to adults and referrals for children will not be accepted
- Adults discharged from hospital with a clinical diagnosis of COVID-19 and have been included in the PHOSP-COVID study
- Patients unable to provide informed consent by themselves
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
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 |
---|---|---|
Number of participants with symptoms at presentation to the research clinic
時間枠:September 2020 - August 2024
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Patient reported symptoms
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September 2020 - August 2024
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Short Physical Performance Battery
時間枠:September 2020 - August 2024
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Assessment of functional capacity
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September 2020 - August 2024
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Quadricep muscle strength
時間枠:September 2020 - August 2024
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Assessment of functional capacity using a handheld dynamometer
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September 2020 - August 2024
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Chalder's Fatigue Score
時間枠:September 2020 - August 2024
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Assessment of fatigue using the Chalder 11-item fatigue questionnaire
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September 2020 - August 2024
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Number of participants with rehabilitation needs at presentation to clinic
時間枠:September 2020 - August 2024
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Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
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September 2020 - August 2024
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EQ-5D-5L
時間枠:September 2020 - August 2024
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Assessment of generic health status using the EQ-5D-5L questionnaire
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September 2020 - August 2024
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Montreal Cognitive Assessment
時間枠:September 2020 - August 2024
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Assessment of cognitive state using the MoCA questionnaire
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September 2020 - August 2024
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Anxiety and Depression
時間枠:September 2020 - August 2024
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Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
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September 2020 - August 2024
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Pittsburgh Sleep Quality Index
時間枠:September 2020 - August 2024
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Assessment of sleep quality using the PSQI questionnaire
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September 2020 - August 2024
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Healthcare service needs following COVID-19 diagnosis
時間枠:September 2020 - August 2032
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Monitoring of NHS records for incidence of re-presentation to primary or secondary care related to COVID-19 complications and survival.
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September 2020 - August 2032
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Biological markers of recovery from COVID-19
時間枠:September 2020 - August 2032
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Assessment of blood taken for clinical purposes (where available) including renal function, liver function, full blood count, HbA1C, Brain natriuretic peptide, vitamin D, thyroid function, C-reactive protein (CRP), Creatine kinase for markers of COVID-19 recovery.
Batched inflammatory and metabolic markers as well as whole blood DNA will also be assessed from stored samples.
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September 2020 - August 2032
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Fried Frailty Index
時間枠:September 2020 - August 2024
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Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
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September 2020 - August 2024
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Body composition
時間枠:September 2020 - August 2024
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Body composition derived from bioelectrical impedance analysis to determine: body mass index, fat free mass index, fat free mass (kg), fat mass (kg).
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September 2020 - August 2024
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協力者と研究者
捜査官
- 主任研究者:Charlotte Bolton、University of Nottingham & Nottingham University Hospitals NHS Trust
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20RM056
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
COVID19の臨床試験
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Israel Institute for Biological Research (IIBR)完了
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Colgate Palmolive完了
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Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., Ltd積極的、募集していない
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University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital Zürich招待による登録