Study protocol for the COPE study: COVID-19 in Older PEople: the influence of frailty and multimorbidity on survival. A multicentre, European observational study

BMJ Open. 2020 Sep 29;10(9):e040569. doi: 10.1136/bmjopen-2020-040569.

Abstract

Introduction: This protocol describes an observational study which set out to assess whether frailty and/or multimorbidity correlates with short-term and medium-term outcomes in patients diagnosed with COVID-19 in a European, multicentre setting.

Methods and analysis: Over a 3-month period we aim to recruit a minimum of 500 patients across 10 hospital sites, collecting baseline data including: patient demographics; presence of comorbidities; relevant blood tests on admission; prescription of ACE inhibitors/angiotensin receptor blockers/non-steroidal anti-inflammatory drugs/immunosuppressants; smoking status; Clinical Frailty Score (CFS); length of hospital stay; mortality and readmission. All patients receiving inpatient hospital care >18 years who receive a diagnosis of COVID-19 are eligible for inclusion. Long-term follow-up at 6 and 12 months is planned. This will assess frailty, quality of life and medical complications.Our primary analysis will be short-term and long-term mortality by CFS, adjusted for age (18-64, 65-80 and >80) and gender. We will carry out a secondary analysis of the primary outcome by including additional clinical mediators which are determined statistically important using a likelihood ratio test. All analyses will be presented as crude and adjusted HR and OR with associated 95% CIs and p values.

Ethics and dissemination: This study has been registered, reviewed and approved by the following: Health Research Authority (20/HRA1898); Ethics Committee of Hospital Policlinico Modena, Italy (369/2020/OSS/AOUMO); Health and Care Research Permissions Service, Wales; and NHS Research Scotland Permissions Co-ordinating Centre, Scotland. All participating units obtained approval from their local Research and Development department consistent with the guidance from their relevant national organisation.Data will be reported as a whole cohort. This project will be submitted for presentation at a national or international surgical and geriatric conference. Manuscript(s) will be prepared following the close of the project.

Keywords: geriatric medicine; health policy; public health.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Aged
  • Betacoronavirus / isolation & purification
  • COVID-19
  • Coronavirus Infections* / diagnosis
  • Coronavirus Infections* / mortality
  • Coronavirus Infections* / therapy
  • Correlation of Data
  • Europe / epidemiology
  • Female
  • Frail Elderly* / psychology
  • Frail Elderly* / statistics & numerical data
  • Frailty* / diagnosis
  • Frailty* / epidemiology
  • Geriatric Assessment / methods
  • Hospitalization / statistics & numerical data
  • Humans
  • Male
  • Multicenter Studies as Topic
  • Multimorbidity*
  • Observational Studies as Topic
  • Pandemics*
  • Pneumonia, Viral* / diagnosis
  • Pneumonia, Viral* / mortality
  • Pneumonia, Viral* / therapy
  • Public Health / methods*
  • Quality of Life*
  • SARS-CoV-2
  • Survival Analysis