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Regular asymptomatic COVID-19 testing in care home staff

Shaping care home COVID- testing policy: a pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13296529
Enrollment
280
Registered
2022-12-05
Start date
2022-12-05
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of severe COVID-19 (SARS-CoV-2 infection) related outcomes in care home residents Infections and Infestations

Interventions

Intervention: Regular asymptomatic testing of care home staff for COVID-19 using lateral flow devices (LFDs) combined with support payments for sickness absence in those who test positive. Control: CO

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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. 2. All care home staff, residents, visitors and relatives are eligible to participate in interviews undertaken as part of the process evaluation. 3. All care home residents at participating homes are eligible for data collection and analysis of the outcomes specified.

Exclusion criteria

Exclusion criteria: 1. Visitors, residents and relatives are not eligible to take part in the testing intervention. 2. 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

Design outcomes

Primary

MeasureTime frame
The incidence of COVID-19-related hospital admissions in residents, defined as admissions with 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 24 h following admission or in the 7 days before hospital admission. This has been selected because it is the most important outcome for policymakers.

Secondary

MeasureTime frame
1. Incidence rate of hospital admissions (all-cause) in residents for non-elective care, measured as events per 100,000 person-days of follow-up over the duration of the trial 2. Incidence rate of COVID-associated mortality in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial* 3. Incidence of all-cause mortality in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial 4. Testing uptake in staff, measured as the proportion of staff at each home participating in testing during each week of the trial 5. Prevalence of SARS-CoV-2 among staff who test, measured as the proportion of staff with positive test results among those with at least one test recorded during each week of the trial 6. Incidence rate of SARS-CoV-2 infections detected in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial 7. Incidence rate of home-level outbreaks, measured as events per 1000 days of follow-up over the duration of the trial 8. Duration of outbreaks, measured as days from first to last case within outbreaks occurring within the trial period 9. Incidence rate of care home closures due to outbreaks, measured as events per 1000 days of follow-up over the duration of the trial 10. Proportion of staff per home who are off sick at each home during each week of the trial 11. Proportion of all shifts filled by agency staff at each home during each week of the trial *COVID-associated mortality will be defined as death within 28 days of a positive SARS-CoV-2 test and/or COVID-19 recorded as the primary or secondary cause of death on the death certificate (using ICD-10 coding)

Countries

England, United Kingdom

Contacts

Public ContactCCTU Enquiries
cctu-enquiries@ucl.ac.uk+44 (0)20 7907 4669

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026