NoRCoRP Assessment Clinic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression | Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire | September 2020 - August 2024 | 
| Pittsburgh Sleep Quality Index | Assessment of sleep quality using the PSQI questionnaire | September 2020 - August 2024 | 
| Healthcare service needs following COVID-19 diagnosis | 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 | 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 | Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains. | September 2020 - August 2024 | 
| Body composition | 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 |