Profiling Recovery of Those Discharged Into the Community With COVID-19

NCT04649957 | Completed DMC

• 1 other identifier: COVID-19-UoD&RDH20/21
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there are few studies that have been established that consist of a variety of established and coherent approaches that sought to profile the determinants of recovery, nor used interrogative procedures to understand lasting physical impairment. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide an important insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function \[4\]. Indeed, current approaches are being developed to support patients using previous knowledge from other acute respiratory infections (e.g. Acute Respiratory Distress Syndrome; ARDS and Middle Eastern Respiratory Syndrome; MERS), approaches that do not consider the novel challenges presented by COVID-19. The knowledge obtained from the proposed research plan will inform the development of COVID-19 specific rehabilitation and clinical management guidelines which can be implemented globally to increase patient wellbeing, physical capacity, and functional status which will be directly related national and international health and wellbeing, economical and societal impacts.

Conditions

Infections, Respiratory; Respiratory Physiology; Respiratory Muscle; Symptoms and General Pathology

Keywords

Respiratory; COVID-19; Recovery; Functional Status

Outcome Measures

Primary Outcomes (1)

• Post-COVID-19 Functional Status (PCFS) Scale

  The PCFS offers the full spectrum of functional outcomes, and focuses on both limitations in usual duties/activities and changes in lifestyle in six scale grades.

  16 weeks

Secondary Outcomes (1)

• EQ-5D-5L

  16 weeks

Study Arms (1)

Cohort Observation

Study investigators will identify eligible participants within 72 hours of expected discharge from hospital. Eligibility will be determined using the criteria outlined in section 5.1 which incorporates the Post-COVID-19 Functional Status (PCFS) Scale, a tool which has been developed and endorsed by the European Respiratory Society to measure functional status over time following COVID-19 infection. Patients graded 2, 3 or 4 on the PCFS will be eligible for participation. Eligible patients will be provided with a detailed explanation of the study including the provision of written information (PIS). Patients will be given time to consider participation in the research study before being approached again by the research team. If the patient expresses an interest in study participation the research team will invite participants to a baseline data collection session that will be held at the University of Derby (Kedleston Road campus) in the days following discharge.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study investigators will identify eligible participants within 72 hours of expected discharge from hospital. Eligibility will be determined using the criteria outlined in section 5.1 which incorporates the Post-COVID-19 Functional Status (PCFS) Scale, a tool which has been developed and endorsed by the European Respiratory Society to measure functional status over time following COVID-19 infection. Patients graded 2, 3 or 4 on the PCFS will be eligible for participation. Eligible patients will be provided with a detailed explanation of the study including the provision of written information (PIS). Patients will be given time to consider participation in the research study before being approached again by the research team. If the patient expresses an interest in study participation the research team will invite participants to a baseline data collection session that will be held at the University of Derby (Kedleston Road campus) in the days following discharge.

You may qualify if:

• Adult patients aged \>18 years, including immunocompromised patients
• Admitted to hospital for treatment for mild/moderate COVID-19 (from NLR and PLR ratios and grade 2, 3 or grade 4 using PCFS Scale).
• Chest radiograph/CT scan consistent with COVID-19 infection.
• Able to understand verbal or written information in English

You may not qualify if:

• Below 18 years of age
• No confirmed diagnosis of COVID-19.
• Achieving a grade 0 or 1 on the PCFS.
• Not admitted to hospital/critical care for treatment of COVID-19.
• Reduced or lack of mental capacity
• Not able to understand verbal or written information in English

Sponsors & Collaborators

• University of Derby: lead
• Sheffield Hallam University: collaborator
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator

Study Sites (1)

University of Derby

Derby, DE22 1GB, United Kingdom

Location

Related Publications (1)

• Thomas C, Faghy MA, Owen R, Yates J, Ferraro F, Bewick T, Haggan K, Ashton REM. Lived experience of patients with Long COVID: a qualitative study in the UK. BMJ Open. 2023 Apr 26;13(4):e068481. doi: 10.1136/bmjopen-2022-068481.

  PMID: 37185640 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Pathological Conditions, Signs and Symptoms; COVID-19

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Mark A Faghy, PhD

  University of Derby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Exercise Physiology

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 2, 2020
• Study Start: August 1, 2021
• Primary Completion: September 6, 2023
• Study Completion: December 21, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)