COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN63437172

Rachel Brierley

r.brierley@bristol.ac.uk

2021-12-10

Recruiting

RCT

Randomized

Cluster

Open label

multi-center

Prevention

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)

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.

2

University of Bristol

18

100

United Kingdom

Healthy volunteers

N/A

740

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

Not reported

[{"arm_notes": "", "treatment_id": 2099, "treatment_name": "Hepa air filters", "treatment_type": "Protective device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]