Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000977471
Ethics application status
Approved
Date submitted
19/08/2025
Date registered
4/09/2025
Date last updated
4/09/2025
Date data sharing statement initially provided
4/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acceptability and Feasibility of a pressure injury prevention system in Residential Aged Care
Scientific title
Staff Acceptability and Feasibility of a pressure injury prevention system in Residential Aged Care
Secondary ID [1] 315178 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure Injury 338621 0
Condition category
Condition code
Skin 334917 334917 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the acceptability and feasibility of a ‘smart sheet’ technology, which is a pressure injury prevention system (PIPS) aimed at providing objective pressure data to guide repositioning care and clinical decision making. PIPS is a ‘smart sheet’ technology which uses a pressure sensing mat integrated into the support surface and is connected to a visual three-dimensional computer display at the patient’s bedside detailing a full-body graphic pressure image. Clinicians and carers can use the image as a real-time guide to patient specific cumulative tissue pressure. Additionally, PIPS delivers time-sensitive alerts signal to care staff to patients with prolonged periods of pressure which requires prioritised repositioning, Whilst similar technologies have been shown to assist in PI prevention in hospital settings, there is no Residential Aged Care specific data available. This study will focus on the feasibility and staff acceptability of PIPS in residential aged care. PIPS is registered with TGA (ARTG ID 475785)
PIPS is a Smart Sheet System which can be fitted onto any mattress converting it into a patient monitoring platform. A-I software analyses smart sheet data to log patient
position and high-pressure areas. PIPS does not act upon the participant in any way, and the information provided by the display is an adjunct to standard care that clinicians provide. Eligible residents were invited to participate and need to change their current mattress and consent to same. This change was highlighted in the participant
information sheet. PIPS mattress remained in place continuously for a 12 week period. Minute by minute electronic data was collected by PIPS to assess adherence.
Intervention code [1] 331794 0
Prevention
Intervention code [2] 331859 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342539 0
Feasibility of Pressure Injury Prevention System as assessed by recruitment and retention data extracted from enrolment and withdrawal logs completed by researchers.
Timepoint [1] 342539 0
Baseline and Week 12 (end of intervention)
Primary outcome [2] 342626 0
Staff acceptability of Pressure Injury Prevention System as assessed by Technology Acceptance survey and one-on-one face-to-face structured interviews with staff undertaken by member of research team.
Timepoint [2] 342626 0
Week 12 (end of intervention)
Secondary outcome [1] 451239 0
Determine preliminary effectiveness of PIPS in altering repositioning compliance as measured by repositioning frequency data and cumulative 'at risk' minutes data which will be derived from PIPS recorded data.
Timepoint [1] 451239 0
Baseline Vs Mean intervention changes (Mean Week 1-12 data) PIPS repositioning frequency data and cumulative 'at risk' minutes will be collected weekly from baseline until week 12, Final analysis will compare baseline data with mean combined intervention period data (ie mean weeks -12)

Eligibility
Key inclusion criteria
Resident Participants:
Inclusion criteria for participation will be as follows:
• Current residents at participating Residential Aged Care facility
• No current pressure injuries
• Deemed 'at risk' of developing pressure injury as per Braden Pressure Score (between 12-18)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participation will be as follows:
• Residents currently on an alternating pressure air mattress
• Residents with planned periods of leave/admission to hospital during the study period.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a pilot acceptability and feasibility study. There will be five PIPS device trialed across 5 RAC residents. Feasibility data and Technology Acceptance Model scores will be reported as descriptive statistics. Staff acceptability interviews will be analysed using content analysis and will be analysed using the theoretical domain framework. Preliminary effectiveness data will have minimal statistical analysis given there are only 5 participants, however it is envisaged that mean differences and Wilcoxin signed-rank analysis will be undertaken.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/11/2024
Date of last participant enrolment
Anticipated
Actual
25/11/2024
Date of last data collection
Anticipated
Actual
17/02/2025
Sample size
Target
5
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 306813 0
University
Name [1] 306813 0
University of Canberra
Country [1] 306813 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Country
Australia
Secondary sponsor category [1] 322255 0
None
Name [1] 322255 0
Address [1] 322255 0
Country [1] 322255 0
Other collaborator category [1] 283622 0
Commercial sector/Industry
Name [1] 283622 0
Lenexa Medical
Address [1] 283622 0
Country [1] 283622 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306977 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 306977 0
Ethics committee country [1] 306977 0
Australia
Date submitted for ethics approval [1] 306977 0
23/05/2024
Approval date [1] 306977 0
30/06/2024
Ethics approval number [1] 306977 0
202413659

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

Contacts
Principal investigator
Name 105626 0
A/Prof Aisling Smyth
Address 105626 0
Centre for Ageing Research and Translation, University of Canberra, 11 Kirinari Street Bruce ACT 2617
Country 105626 0
Australia
Phone 105626 0
+61 448 157846
Fax 105626 0
Email 105626 0
[email protected]
Contact person for public queries
Name 105627 0
Aisling Smyth
Address 105627 0
Centre for Ageing Research and Translation, University of Canberra, 11 Kirinari Street Bruce ACT 2617
Country 105627 0
Australia
Phone 105627 0
+61 2 6201 5111
Fax 105627 0
Email 105627 0
[email protected]
Contact person for scientific queries
Name 105628 0
Aisling Smyth
Address 105628 0
Centre for Ageing Research and Translation, University of Canberra, 11 Kirinari Street Bruce ACT 2617
Country 105628 0
Australia
Phone 105628 0
+61 448 157846
Fax 105628 0
Email 105628 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


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.