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NoRCoRP Assessment Clinic (NoRCoRP)

15 februari 2021 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

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

Observationell

Inskrivning (Förväntat)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

      • Nottingham, Storbritannien, NG5 1PB
        • Rekrytering
        • Nottingham City Hospital
        • Kontakt:
          • Charlotte Bolton

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

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
Patient reported symptoms
September 2020 - August 2024
Short Physical Performance Battery
Tidsram: September 2020 - August 2024
Assessment of functional capacity
September 2020 - August 2024
Quadricep muscle strength
Tidsram: September 2020 - August 2024
Assessment of functional capacity using a handheld dynamometer
September 2020 - August 2024
Chalder's Fatigue Score
Tidsram: 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
Tidsram: 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
Tidsram: September 2020 - August 2024
Assessment of generic health status using the EQ-5D-5L questionnaire
September 2020 - August 2024
Montreal Cognitive Assessment
Tidsram: September 2020 - August 2024
Assessment of cognitive state using the MoCA questionnaire
September 2020 - August 2024

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
September 2020 - August 2024
Pittsburgh Sleep Quality Index
Tidsram: September 2020 - August 2024
Assessment of sleep quality using the PSQI questionnaire
September 2020 - August 2024
Healthcare service needs following COVID-19 diagnosis
Tidsram: 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
Tidsram: 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
Tidsram: September 2020 - August 2024
Frailty assessment covering: shrinking, exhaustion, physical activity, slowness and weakness domains.
September 2020 - August 2024
Body composition
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Charlotte Bolton, University of Nottingham & Nottingham University Hospitals NHS Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 december 2020

Primärt slutförande (Förväntat)

31 augusti 2032

Avslutad studie (Förväntat)

31 augusti 2032

Studieregistreringsdatum

Först inskickad

10 december 2020

Först inskickad som uppfyllde QC-kriterierna

12 januari 2021

Första postat (Faktisk)

15 januari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 februari 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 februari 2021

Senast verifierad

1 februari 2021

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Covid19

3
Prenumerera