Respiratory infections, including COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
1. Study design
This is a two-arm, cluster randomisation trial of portable HEPA air filters versus no air filters for reducing symptomatic winter respiratory infections (including COVID-19) in care ho
and socioeconomic tertile (high/medium/low) using a randomisation list pre-generated by a CTU statistician with no other involvement in recruitment activities. Participants in each care home will be r
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Care homes: 1. =30 residents residing in single bedrooms* 2. Care homes that predominantly focus on care for older people (residential home/nursing home) 3. Willing to maintain a register of all residents, to be updated weekly until the end of February (after which new residents will not be invited) 4. Willing to invite residents to receive air filters and/or accept medical notes review until ten agree (“the ten”) per care home 5. Willing to provide anonymised resident infection data, administer brief resident and staff questionnaires, and respond to data queries 6. Care home owner permission to take part in the study 7. Willing to commit to installing air filters in the care home if allocated to the intervention group 8. Willing to commit to not installing air filters if allocated to control group *Single bedrooms: residents residing in a room of single occupancy will be referred to as residents in a private and/or single bedroom. Residents may share bathroom facilities. All residents: 1. Expected to reside in the care home for at least 2 months of the care home data collection period Consented residents – ‘the ten’: The following eligibility criteria are for “the ten” residents invited to receive an air filter and/or permit medical notes review only: 1. In a single-occupancy bedroom 2. Expected to reside in the care home for at least 2 months of the care home data collection period 3. Able to give informed consent (or if lacks capacity, a consultee is willing to complete a consultee declaration form)
Exclusion criteria
Exclusion criteria: Care homes: 1. CQC website rates as ‘inadequate’ or ‘requiring improvements’ 2. =10% private bedroom use of portable HEPA filtration devices 3. Participating in a competing care home level study All residents: 1. Terminal illness (death expected within 7 days) Consented residents – ‘the ten’: 1. Participating in any interventional* study 2. Terminal illness (death expected within 7 days) *Interventional study: Interventional studies are those which involve an ‘intervention’. In medical terms this could be a drug treatment, surgical procedure, diagnostic test or psychological therapy. Examples of public health interventions could include action to help someone to be physically active or to eat a more healthy diet. Examples of social care interventions could include safeguarding or support for carers. If a site becomes aware that a participant has enrolled in an interventional study whilst taking part in AFRI-c, they should inform the central research team (UoB). The research team will evaluate whether it is appropriate for the resident to continue participating in AFRI-c.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/10/2024: Number of symptomatic winter respiratory infection episodes measured using case report forms (CRFs) completed by staff and/or the resident per winter, defined as the period starting on 1 September and ending on 31 May Previous primary outcome measure: Number of symptomatic winter respiratory infection episodes measured using case report forms (CRFs) completed by staff and/or the resident per winter, defined as the period starting on 1 September and ending on 30 April | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/10/2024: 1. Number of days with respiratory infection symptoms measured using the AFRI-c data collection form completed by staff daily throughout the study period 2. Presence of fever and/or delirium and/or acute deterioration in physical ability measured using the AFRI-c data collection form completed by staff daily throughout the study period 3. Number of gastro-intestinal infection episodes and number of symptomatic days of gastro-intestinal infection symptoms measured using the AFRI-c data collection form completed by staff daily throughout the study period 4. Number of days antibiotics are consumed and prescribed (number and name) measured using the AFRI-c data collection form completed by staff daily throughout the study period 5. Number of falls/near falls measured using the AFRI-c data collection form completed by staff daily throughout the study period 6. Number of possible SARS-CoV-2 infection episodes and possible Influenza-like illness episodes measured using the AFRI-c data collection form completed by staff daily throughout the study period 7. Number of PCR confirmed SARS-CoV-2 infections measured through linkage with UKHSA per winter 8. Number of PCR (or other test) confirmed Influenza A&B infections measured through linkage with UKHSA per winter 9. Number of other microbiologically confirmed infections as investigated by PHE during care home outbreaks, including Streptococcal, Meningococcal, Respiratory Syncytial Virus, Norovirus, and Human Metapneumovirus infections measured through linkage with UKHSA per winter 10. Number of diagnosed respiratory (including COVID), gastrointestinal, skin, and urinary infections measured using medical records check per winter 11. Perception of care home environment measured using staff and resident questionnaires per winter 12. Number of staff sickness days away from work measured using the AFRI-c data collection form completed by staff per winter 13. Number of staff sickn | — |
Countries
England, United Kingdom
Outcome results
None listed