BMJ Open (May 2023)

Impact of the COVID-19 pandemic on people in need of care or support: protocol for a SARS-CoV-2 registry

  • ,
  • Ildikó Gágyor,
  • Tobias Dreischulte,
  • Susann Hueber,
  • Thomas Kühlein,
  • Michael Hoelscher,
  • Jochen Gensichen,
  • Michael Hölscher,
  • Peter Konstantin Kurotschka,
  • Linda Sanftenberg,
  • Isabel Zöllinger,
  • Anita Hausen,
  • Christian Janke,
  • Armin Nassehi,
  • Daniel Teupser,
  • Florian M Arend,
  • Christine Eidenschink,
  • Dagmar Hindenburg,
  • Helena Kosub,
  • Daniela Lindemann,
  • Katharina Mayr,
  • Susan Müller,
  • Laura Rink,
  • Marietta Rottenkolber,
  • Rita Schwaiger,
  • Maria Sebastião,
  • Domenika Wildgruber,
  • Florian Arend,
  • Laura Baumgartner,
  • Barbara Daubner,
  • Dorothea Fichtl,
  • Caroline Floto,
  • Johannes Gorkotte,
  • Stephanie Kalms,
  • Peter Kurotschka,
  • Irina Michel,
  • Britta Pauli,
  • Constantin Unger,
  • Sabrina Vetter

DOI
https://doi.org/10.1136/bmjopen-2022-071134
Journal volume & issue
Vol. 13, no. 5

Abstract

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Introduction People in need of care or support are severely affected by the COVID-19 pandemic. We lack valid data of long-term assessments. We present a register study to detect the physical and psychosocial impact of the COVID-19 pandemic on people in need of care or support in Bavaria, Germany. To describe the persons’ life conditions comprehensively, we assess the perspectives and needs of the respective care teams too. Results will serve as evidence-based source to manage the pandemic and long-term prevention strategies.Methods and analysis The ‘Bavarian ambulatory COVID-19 Monitor’ is a multicentre registry including a purposive sample of up to 1000 patient–participants across three study sites in Bavaria. The study group consists of 600 people in need of care with a positive SARS-CoV-2 PCR test. Control group 1 comprises 200 people in need of care with a negative SARS-CoV-2 PCR test, while control group 2 comprises 200 people with a positive SARS-CoV-2 PCR test but are not in need of care. We assess the clinical course of infection, psychosocial aspects and care needs using validated measures. Follow-up is every 6 months for up to 3 years. Additionally, we assess up to 400 people linked to these patient–participants (caregivers, general practitioners (GPs)) for their health and needs. Main analyses are stratified by level of care I–V (I=minor/V=most severe impairment of independence), inpatient/outpatient care setting, sex and age. We use descriptive and inferential statistics to analyse cross-sectional data and changes over time. In qualitative interviews with 60 stakeholders (people in need of care, caregivers, GPs, politicians), we explore interface problems of different functional logics, of everyday and professional perspectives.Ethics and dissemination The Institutional Review Board of the University Hospital LMU Munich (#20-860) and the study sites (Universities of Wurzburg and Erlangen) approved the protocol. We disseminate the results by peer-reviewed publications, international conferences, governmental reports, etc.