Created at Source Raw Value Validated value
Dec. 15, 2021, 3 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "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 home residents with a mixed-method process and economic evaluation. The RCT design is the most scientifically rigorous method of hypothesis testing available and is regarded as the gold standard trial for evaluating the effectiveness of interventions. Care homes are allocated to the two treatment arms by stratifying whether they provide nursing care yes/no; 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 randomly approached for consent either to have an air filter in their private room and access to their medical records (intervention arm) or access to their medical records only (control arm). Care homes in both arms will follow usual care in terms of infection prevention and control strategies such as hand washing. Care homes have a 50/50 chance of being allocated to either arm. The null hypothesis is that there is no difference between the number of symptomatic days at the end of the winter period with or without air filters in care home residents. 2. Blinding The central research team; clinicians; other researchers; care home staff and participants will be not remain blinded to the allocation of the intervention group. The Trial Management Group (TMG) will not review unblinded data until all follow-up and data queries have been resolved at the end of the trial. Two statisticians based at the University of Bristol (UoB) will support this trial.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"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"}]