Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000749505
Ethics application status
Approved
Date submitted
18/06/2015
Date registered
20/07/2015
Date last updated
8/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the clinical utility of the electronic toilet top bidet for use with Australian nursing home residents and staff.
Scientific title
For nursing home residents, does consistent use of the electronic wash and dry toilet top bidet clean more effectively after voiding bladder or bowels and reduce bacteriurea, incontinence associated dermatitis and cost of incontinence products than usual toileting care?
Secondary ID [1] 286793 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cleaning after toilet use in nursing home residents 295084 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295332 295332 0 0
Occupational therapy
Infection 295333 295333 0 0
Studies of infection and infectious agents
Skin 295334 295334 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The electronic, wash-and-dry toilet top bidet will be used by nursing home staff after each toileting episode for residents. The bidet used in this investigation is a toilet seat replacement that provides a heated seat; two retractable, self cleaning nozzles that provide a thermostatically controlled warm water wash of the perineum or perianal area after voiding bladder or bowels; and a warm air blower to dry the user after washing. The bidet is operated by a remote control unit. The bidet to be used is the Coway BA-08. Effects of use of the bidet on cleanliness, bacteriurea, incontinence-associated dermatitis and other effects will be observed over a 12-week intervention period.
Intervention code [1] 291877 0
Prevention
Intervention code [2] 291878 0
Treatment: Devices
Comparator / control treatment
No bidet, usual toileting care which consists of wiping with toilet paper, washing the perineum with damp face washers/proprietary wipes and/or application of topical emollients where indicated.
Control group
Active

Outcomes
Primary outcome [1] 295080 0
Nursing home residents will be effectively cleaned after voiding bladder or bowels assessed by nursing home care staff.
Timepoint [1] 295080 0
Baseline, 6 weeks and 12 weeks
Primary outcome [2] 295081 0
Urine bacterial colony counts compared to baseline and controls
Timepoint [2] 295081 0
Baseline, weeks 3,6,9 and 12
Primary outcome [3] 295082 0
Acceptability of bidet for nursing home residents, assessed on 5-point Likert scale.
Timepoint [3] 295082 0
Baseline and 12 weeks.
Secondary outcome [1] 314868 0
Rates of incontinence associated dermatitis as assessed by the Incontinence Associated Dermatitis (IAD) Scale (Borchert et al 2010).
Timepoint [1] 314868 0
Baseline, 6 weeks, 12 weeks.
Secondary outcome [2] 314869 0
Non-dietary aperient use in comparison to baseline as recorded in the resident aged care file.
Timepoint [2] 314869 0
Baseline, 12 weeks
Secondary outcome [3] 314870 0
Cost of incontinence products used, taken from financial data provided by participating facilities' accounting departments.
Timepoint [3] 314870 0
12 weeks pre-trial, 12 weeks during trial, 12 weeks of corresponding period in previous financial year.

Eligibility
Key inclusion criteria
a. Permanent resident of an accredited Australian Residential Aged Care Facility
b. Require assistance to toilet
c. Have capacity to consent or have proxy consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have any condition that would contraindicate use of bidet, on the recommendation of facility staff or resident's GP

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Resident-participants are chosen by staff of participating nursing homes. Reasons for selection form part of study data.
Concealment is not possible for use of device.
Number of participants is determined by number of bidets purchased by participating nursing homes.
Estimated sample size: 48
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
this is a non-randomised, pre and post controlled comparison, pragmatic pilot trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will compare frequencies and t-tests and chi square will determine group differences.
Differences between groups over time (including colony counts of bacteria in urine)will be analysed using analysis of co-variance.
Focus group: line-by-line analysis of verbatim transcribed data
Cost utilisation: descriptive statistics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2015
Actual
20/07/2015
Date of last participant enrolment
Anticipated
30/05/2016
Actual
30/05/2016
Date of last data collection
Anticipated
Actual
10/08/2016
Sample size
Target
48
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 291329 0
Charities/Societies/Foundations
Name [1] 291329 0
Australian Unity Heritage Fellowship
Country [1] 291329 0
Australia
Funding source category [2] 291330 0
Charities/Societies/Foundations
Name [2] 291330 0
The Dementia Centre, HammondCare
Country [2] 291330 0
Australia
Funding source category [3] 291331 0
University
Name [3] 291331 0
The University of Sydney
Country [3] 291331 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Sydney University, Cumberland Campus
East Street Lidcombe 2141 NSW
Country
Australia
Secondary sponsor category [1] 290012 0
None
Name [1] 290012 0
Address [1] 290012 0
Country [1] 290012 0
Other collaborator category [1] 278478 0
Individual
Name [1] 278478 0
A/Prof Lee-Fay Low
Address [1] 278478 0
Ageing Work and Health Research Unit
M Block Cumberland Campus,
Sydney University
East Street Lidcombe 2141
Country [1] 278478 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292894 0
Sydney University Human Reserach Ethics Committee
Ethics committee address [1] 292894 0
Ethics committee country [1] 292894 0
Australia
Date submitted for ethics approval [1] 292894 0
Approval date [1] 292894 0
08/05/2015
Ethics approval number [1] 292894 0
2015/304

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57302 0
Prof Lindy Clemson
Address 57302 0
Ageing Work and Health Research Unit
M Block, Cumberland Campus
Sydney University
East St
Lidcombe 2141 NSW
Country 57302 0
Australia
Phone 57302 0
+61 2 9351 9372
Fax 57302 0
Email 57302 0
[email protected]
Contact person for public queries
Name 57303 0
Lindy Clemson
Address 57303 0
Ageing Work and Health Research Unit
M Block, Cumberland Campus
Sydney University
East St
Lidcombe 2141 NSW
Country 57303 0
Australia
Phone 57303 0
+61 2 9351 9372
Fax 57303 0
Email 57303 0
[email protected]
Contact person for scientific queries
Name 57304 0
Lindy Clemson
Address 57304 0
Ageing Work and Health Research Unit
M Block, Cumberland Campus
Sydney University
East St
Lidcombe 2141 NSW
Country 57304 0
Australia
Phone 57304 0
+61 2 9351 9372
Fax 57304 0
Email 57304 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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