NoRCoRP Assessment Clinic
- Conditions
- Covid19
- Registration Number
- NCT04710836
- Lead Sponsor
- Nottingham University Hospitals NHS Trust
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with symptoms at presentation to the research clinic September 2020 - August 2024 Patient reported symptoms
Quadricep muscle strength September 2020 - August 2024 Assessment of functional capacity using a handheld dynamometer
Number of participants with rehabilitation needs at presentation to clinic September 2020 - August 2024 Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
EQ-5D-5L September 2020 - August 2024 Assessment of generic health status using the EQ-5D-5L questionnaire
Montreal Cognitive Assessment September 2020 - August 2024 Assessment of cognitive state using the MoCA questionnaire
Chalder's Fatigue Score September 2020 - August 2024 Assessment of fatigue using the Chalder 11-item fatigue questionnaire
Short Physical Performance Battery September 2020 - August 2024 Assessment of functional capacity
- Secondary Outcome Measures
Name Time Method Healthcare service needs following COVID-19 diagnosis 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.
Fried Frailty Index September 2020 - August 2024 Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
Biological markers of recovery from COVID-19 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.
Body composition 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).
Anxiety and Depression September 2020 - August 2024 Derived by completion of the Hospital Anxiety and Depression Scale (HADS) questionnaire
Pittsburgh Sleep Quality Index September 2020 - August 2024 Assessment of sleep quality using the PSQI questionnaire
Trial Locations
- Locations (1)
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom