Shaping Care Home COVID-19 Testing Policy

NCT05639205 | Unknown Phase 3 DMC

• 1 other identifier: CTU/2022/405
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this interventional study is to investigate whether continued use of regular asymptomatic testing in staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes. The trial aims to quantify the benefits and harms of regular asymptomatic testing in care home staff to inform policy. The rationale for regular asymptomatic testing is that it may reduce the risk of severe disease in residents and the frequency/severity of outbreaks. Participants (care home staff) will perform regular asymptomatic tests for Covid-19. Should they test positive they will be required to refrain from working and be provided with sick pay. Care providers will be reimbursed for the costs of employing agency staff to cover staff sickness absence that results directly from the trial.

Conditions

COVID-19

Keywords

Lateral Flow Device

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The primary outcome is the incidence of COVID-19 related hospital admissions in residents, defined as admissions with a relevant ICD-10 codes (COVID hospitalisations to be defined as any hospital admission record with a primary or secondary ICD10 code of 'U071') and/or admissions in residents who test positive for COVID-19 within 24h following admission or in the 7 days before hospital admission. This has been selected because it is the most important outcome for policymakers.

  4 months

Secondary Outcomes (11)

• Incidence rate of hospital admissions

  4 months

• Incidence rate of COVID-associated mortality in residents

  4 months

• Incidence of all-cause mortality in residents

  4 months

• Testing uptake in staff

  Once per week for 4 months

• Prevalence of SARS-CoV-2 among staff who test

  Once per week for 4 months

Study Arms (2)

Arm A

ACTIVE COMPARATOR

LFD testing for Covid-19 with sickness support payment. Care providers will receive funding to reimburse the costs of employing agency staff to cover sickness absence in asymptomatic staff who test positive for COVID.

Diagnostic Test: Lateral Flow Device

Arm B

NO INTERVENTION

Usual Care

Interventions

Lateral Flow Device DIAGNOSTIC_TEST

Regular asymptomatic staff testing with a Lateral Flow Device including support payments if unwell.

Arm A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Only care home staff are eligible to participate in the testing intervention. This includes temporary (agency) staff with no restrictions i.e. catering staff, administrative staff, maintenance staff, in addition to those in a resident-facing role.
• All care home staff, residents, visitors and relatives are eligible to participate in interviews undertaken as part of the process evaluation.
• All care home residents at participating home are eligible for data collection and analysis of the outcomes specified.

You may not qualify if:

• Visitors, residents and relatives are not eligible to take part in the testing intervention.
• Staff who visit the care home to provide care but are not employed by the care home e.g. GPs, health visitors are not eligible to take part in either the interviews or the testing intervention.

Sponsors & Collaborators

• University College, London: lead

Related Publications (1)

• Stirrup O, Blackstone J, Cullen-Stephenson I, Fenner R, Adams N, Leiser R, Krutikov M, Azmi B, Freemantle N, Gordon A, Regan M, Knapp M, Gosce L, Henderson C, Hopkins S, Verma A, Cassell J, Cadar D, Fowler T, Copas A, Flowers P, Shallcross L. VIVALDI-CT shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff. PLoS One. 2025 Jul 2;20(7):e0324908. doi: 10.1371/journal.pone.0324908. eCollection 2025.

  PMID: 40601586 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura Shallcross, Professor

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Shallcross, Professor

CONTACT

0203 549 5540; l.shallcross@ucl.ac.uk

CCTU Enquiries

CONTACT

020 7907 4669; cctu-enquiries@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 6, 2022
• Study Start: December 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 9, 2022

Record last verified: 2022-12