Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000737932
Ethics application status
Approved
Date submitted
27/05/2020
Date registered
14/07/2020
Date last updated
14/07/2020
Date data sharing statement initially provided
14/07/2020
Date results information initially provided
14/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nasal washout and gargling for healthcare staff in Care Homes during the COVID-19 pandemic: The Good-NIGHT COVID pilot study
Scientific title
Good Nasal Irrigation and Gargling for healthcare staff in Care Homes during the COVID-19 pandemic: the GoodNIGHT-COVID pilot feasibility study
Secondary ID [1] 301385 0
Nil Known
Universal Trial Number (UTN)
U1111-1252-7005
Trial acronym
Good-NIGHT COVID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 infection 317642 0
respiratory tract infection 317643 0
COVID-19 pneumonia 317648 0
Condition category
Condition code
Infection 315723 315723 0 0
Studies of infection and infectious agents
Respiratory 315724 315724 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is to ask care home (CH) managers to advise their healthcare staff to perform nasal irrigation and gargling with saline (HSNIG) before and at least once during each shift. The aim of nasal lavage and gargling is to reduce asymptomatic infection with SARS-CoV-2 in healthcare workers, and thus reduce onward transmission to vulnerable care home residents during the COVID-19 pandemic. The nasal rinse and gargling uses saline of approximately 3% salinity up both nostrils and then gargled from a 60 mL Gallipot. The study is a feasibility and pilot study. Outcomes in intervention care homes will be compared to control care homes that will not be advising their staff to perform nasal lavage and gargling.
Each intervention care home will be provided with adequate supplies of Gallipots, salt, stirrers and information leaflets and posters to display to staff.
Training will be provided remotely, prior to the start of the study, by means of both online videos (made available via private links) and written materials. These materials have been designed specifically for the purposes of this study. They are not available publically, to avoid the potential for methodological contamination of the study design. Care home staff will be asked to watch the videos once, but will be able to watch the videos as often as they wish for the duration of the study.
The study will last 12 weeks from the date the first care home starts. Care homes will start in a phased way, determined by recruitment, and no care home will undertake the intervention for less than 8 weeks.
During the study, staff attendance at training sessions, and subsequent adherence/fidelity to HSNIG will be recorded and captured by responses to weekly surveys completed both by care home managers/rinsing champions, and by care home staff.
During the study, care home workers will be asked to perform HSNIG at the care home that they work in before the start of each shift, and as often as possible during the shift.
Intervention code [1] 317690 0
Prevention
Intervention code [2] 317691 0
Treatment: Other
Comparator / control treatment
No intervention (standard care), This will be the usual care provided at the control care home, including whatever infection control practises are in place at that time, as guided by UK government agencies.
Control group
Active

Outcomes
Primary outcome [1] 323932 0
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.
Timepoint [1] 323932 0
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
Secondary outcome [1] 383369 0
The proportion of staff who received training to receive the HSNIG, as measured by surveys completed by managers/weekly champions/care home workers, and by information from qualitative interviews. Online surveys have been dedsigned specifically for this trial. 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.
Timepoint [1] 383369 0
This outcome will be assessed using data collected from surveys completed by the end of week two, with data collected in qualitative interviews through out the whole study. Each Care homer worker will be offered the opportunity to partake in a qualitative interview, but can only do this once. A minimum of 5 and a maximum of 15 such interviews will be performed, at a time during the study period that is convenient to boththe CH worker and the researcher.
Secondary outcome [2] 383381 0
The proportion of staff who opted to use the HSNIG at least once per shift. This outcome will be assessed using Data collected from surveys in weeks one through to eight, with estimates of changes in adherence over time, combined with data collected in qualitative interviews. Online surveys have been dedsigned specifically for this trial. 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.
Timepoint [2] 383381 0
This 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 will be 12 weeks
Secondary outcome [3] 383382 0
The median frequency HSNIG was used per shift, as assessed using weekly surveys of care home staff and care home managers/champions. These online surveys have been dedsigned specifically for this trial.
Timepoint [3] 383382 0
This 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 will be 12 weeks
Secondary outcome [4] 384534 0
The proportion of staff who displayed intention to try the HSNIG, as measured by surveys completed by managers/weekly champions/care home workers, and by information from qualitative interviews. These online surveys have been dedsigned specifically for this trial.
Timepoint [4] 384534 0
This 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 will be 12 weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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%)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Qualitative semi-structured interviews with care home staff
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The pilot phase of the trial will comprise 8 CHs. This is a sufficient number to collect data about the CHs such as theircapacity, mean level of resident acuity and turnover, staffing ratios, baseline (pre epidemic) mortality rate etc. and explore if these factors are significantly associated with mortality or other important outcomes measured during the pilot study. 8 CHs also allows leeway should any have to withdraw due to a change in circumstances meaning they are no longerable to deliver the pilot study. We believe 5-15 CH staff will be sufficient for this pilot study to identify barriers to the utilisation of HSNIG by staff.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
22/05/2020
Date of last participant enrolment
Anticipated
Actual
15/06/2020
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
300
Accrual to date
Final
250
Recruitment outside Australia
Country [1] 22581 0
United Kingdom
State/province [1] 22581 0

Funding & Sponsors
Funding source category [1] 305826 0
Other Collaborative groups
Name [1] 305826 0
NIHR Applied Research Collaboration Wessex
Country [1] 305826 0
United Kingdom
Primary sponsor type
University
Name
University of Southampton
Address
University of Southampton
Highfield
Southampton
SO17 1BJ
Country
United Kingdom
Secondary sponsor category [1] 306269 0
None
Name [1] 306269 0
Address [1] 306269 0
Country [1] 306269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306093 0
Wales Research Ethics Committee 5 Bangor
Ethics committee address [1] 306093 0
Health and Care Research Wales
Castlebridge 4
15-19 Cowbridge Road East
Cardiff
CF11 9AB
United Kingdom
Ethics committee country [1] 306093 0
United Kingdom
Date submitted for ethics approval [1] 306093 0
05/05/2020
Approval date [1] 306093 0
22/05/2020
Ethics approval number [1] 306093 0
20/WA/0162

Summary
Brief summary
Severe acute respiratory syndrome coronas virus (SARS COV-2) has spread quickly around the world and caused many deaths from coronavirus disease 2019 (COVD-19). Elderly people and frail people such as those in care homes are particularly at risk of death from COVID-19 and there are few effective treatments. SARS COV-2 is thought to infect people via the nose and mouth. Current best practise to prevent infection focuses on good hand hygiene, the wearing of masks and by limiting social contact. However, elderly people in care homes have to come into contact with staff members who are looking after them. We would like to know if rinsing of the mouth and nose of care home staff might reduce the incidence of COVID-19 in residents. This study aims to understand whether the proposed methods are feasible and practical for care home staff and researchers, thus informing a future randomised trial.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 102678 0
Dr Thomas Daniels
Address 102678 0
Department of Respiratory Medicine
University Hospital Southampton NHSFT
Tremona Road
Southampton
Hampshire
SO16 6YD
Country 102678 0
United Kingdom
Phone 102678 0
+442381206801
Fax 102678 0
Email 102678 0
[email protected]
Contact person for public queries
Name 102679 0
Dr Thomas Daniels
Address 102679 0
Department of Respiratory Medicine
University Hospital Southampton NHSFT
Tremona Road
Southampton
Hampshire
SO16 6YD
Country 102679 0
United Kingdom
Phone 102679 0
+442381206801
Fax 102679 0
Email 102679 0
[email protected]
Contact person for scientific queries
Name 102680 0
Dr Thomas Daniels
Address 102680 0
Department of Respiratory Medicine
University Hospital Southampton NHSFT
Tremona Road
Southampton
Hampshire
SO16 6YD
Country 102680 0
United Kingdom
Phone 102680 0
+442381206801
Fax 102680 0
Email 102680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised unit of randomisation level data will be available on publication (note the unit is individual care homes, not people)
When will data be available (start and end dates)?
At time of publication for unknown period of time
Available to whom?
Anyone, publically available
Available for what types of analyses?
Any analysis
How or where can data be obtained?
Via publically accesible website. https://osf.io/hfut4/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8092Ethical approval    379905-(Uploaded-27-05-2020-23-21-31)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.