- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04710836
NoRCoRP Assessment Clinic (NoRCoRP)
The Nottingham Recovery From COVID-19 Research Platform Assessment Clinic
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Charlotte Bolton
- Telefonnummer: 54844 01159 691169
- E-post: charlotte.bolton@nottingham.ac.uk
Studera Kontakt Backup
- Namn: Alex Jenkins
- E-post: alex.jenkins@nottingham.ac.uk
Studieorter
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-
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Nottingham, Storbritannien, NG5 1PB
- Rekrytering
- Nottingham City Hospital
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Kontakt:
- Charlotte Bolton
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of participants with symptoms at presentation to the research clinic
Tidsram: September 2020 - August 2024
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Patient reported symptoms
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September 2020 - August 2024
|
Short Physical Performance Battery
Tidsram: 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
Tidsram: September 2020 - August 2024
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Assessment of functional capacity using a handheld dynamometer
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September 2020 - August 2024
|
Chalder's Fatigue Score
Tidsram: September 2020 - August 2024
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Assessment of fatigue using the Chalder 11-item fatigue questionnaire
|
September 2020 - August 2024
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Number of participants with rehabilitation needs at presentation to clinic
Tidsram: September 2020 - August 2024
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Rehabilitation needs based on clinical assessment by a multidisciplinary team (musculoskeletal, cognitive and cardiopulmonary)
|
September 2020 - August 2024
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EQ-5D-5L
Tidsram: 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
Tidsram: September 2020 - August 2024
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Assessment of cognitive state using the MoCA questionnaire
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September 2020 - August 2024
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Anxiety and Depression
Tidsram: September 2020 - August 2024
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Charlotte Bolton, University of Nottingham & Nottingham University Hospitals NHS Trust
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20RM056
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