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NoRCoRP Assessment Clinic (NoRCoRP)

2021年2月15日 更新者:Nottingham University Hospitals NHS Trust

The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic

The main overarching aim of this study is to build a research clinic, as part of the NoRCoRP platform covering Nottingham and Nottinghamshire to facilitate learning and research in the whole population of patients who have had COVID-19.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (预期的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Nottingham、英国、NG5 1PB
        • 招聘中
        • Nottingham City Hospital
        • 接触:
          • Charlotte Bolton

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults who have previous had a diagnosis of COVID-19 and have been referred into a post-COVID-19 respiratory outpatients clinic from primary care due to ongoing complications related to the COVID-19 diagnosis.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of participants with symptoms at presentation to the research clinic
大体时间:September 2020 - August 2024
Patient reported symptoms
September 2020 - August 2024
Short Physical Performance Battery
大体时间:September 2020 - August 2024
Assessment of functional capacity
September 2020 - August 2024
Quadricep muscle strength
大体时间:September 2020 - August 2024
Assessment of functional capacity using a handheld dynamometer
September 2020 - August 2024
Chalder's Fatigue Score
大体时间:September 2020 - August 2024
Assessment of fatigue using the Chalder 11-item fatigue questionnaire
September 2020 - August 2024
Number of participants with rehabilitation needs at presentation to clinic
大体时间:September 2020 - August 2024
Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
September 2020 - August 2024
EQ-5D-5L
大体时间:September 2020 - August 2024
Assessment of generic health status using the EQ-5D-5L questionnaire
September 2020 - August 2024
Montreal Cognitive Assessment
大体时间:September 2020 - August 2024
Assessment of cognitive state using the MoCA questionnaire
September 2020 - August 2024

次要结果测量

结果测量
措施说明
大体时间
Anxiety and Depression
大体时间:September 2020 - August 2024
Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
September 2020 - August 2024
Pittsburgh Sleep Quality Index
大体时间:September 2020 - August 2024
Assessment of sleep quality using the PSQI questionnaire
September 2020 - August 2024
Healthcare service needs following COVID-19 diagnosis
大体时间:September 2020 - August 2032
Monitoring of NHS records for incidence of re-presentation to primary or secondary care related to COVID-19 complications and survival.
September 2020 - August 2032
Biological markers of recovery from COVID-19
大体时间:September 2020 - August 2032
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.
September 2020 - August 2032
Fried Frailty Index
大体时间:September 2020 - August 2024
Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
September 2020 - August 2024
Body composition
大体时间:September 2020 - August 2024
Body composition derived from bioelectrical impedance analysis to determine: body mass index, fat free mass index, fat free mass (kg), fat mass (kg).
September 2020 - August 2024

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Charlotte Bolton、University of Nottingham & Nottingham University Hospitals NHS Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月3日

初级完成 (预期的)

2032年8月31日

研究完成 (预期的)

2032年8月31日

研究注册日期

首次提交

2020年12月10日

首先提交符合 QC 标准的

2021年1月12日

首次发布 (实际的)

2021年1月15日

研究记录更新

最后更新发布 (实际的)

2021年2月17日

上次提交的符合 QC 标准的更新

2021年2月15日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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