COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12620000737932.aspx

Dr Thomas Daniels

thomas.daniels@uhs.nhs.uk

2020-07-14

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Prevention

Any CH with facilities for staff to carry out HSNIG and authority to decide on this and on providing relevant data to the study team

Care Homes where HSNIG has already part of hygiene policy Any CH with a high proportion (50% or more) of agency staff (typically this is approximately 25%)

2

University of Southampton

18

100

United Kingdom

Health workers

N/A

300

This is a pilot feasibility study. The main outcome of the feasibility/pilot study will a composite primary outcome of the feasibility and acceptability of the intervention. Feasibility will be assessed using weekly online surveys of both care home workers and care home managers (or their delegated 'rinsing champion'). All surveys have been specifically dedsigned for this trial. Acceptability will be assessed by weekly surveys and semi-structured qualitative interviews with a self-selecting group of care home staff and managers/champions. Qualitative interviews will be one to one; telephone or video interviews which will be audio recorded and transcibed for analysis. Each interview is expected to last approximately 30 minutes. In addition a log will be kept by managers/champions of how many care home staff have completed the online training.[The primary timepoint will be 8 weeks from the date of starting the intervention/control for each care home. An additional 4 weeks of data collection and time for qualitative interviews will mean the entire duration of the trial will be 12 weeks]

Not reported

[{"arm_notes": "", "treatment_id": 864, "treatment_name": "Nasal irrigation and gargling with saline (hsnig)", "treatment_type": "Mouthwash", "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"}]