Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000277448p
Ethics application status
Not yet submitted
Date submitted
21/02/2025
Date registered
10/04/2025
Date last updated
10/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability of a novel "DialyAssist" device for stabilising needles in the arm when people have haemodialysis
Scientific title
Acceptability of a novel "DialyAssist" device for stabilising needles in arteriovenous fistulae of people receiving haemodialysis
Secondary ID [1] 313807 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
kidney failure requiring renal replacement therapy 336443 0
Condition category
Condition code
Renal and Urogenital 332963 332963 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the novel "DialyAssist" device to stabilise the needles in the arteriovenous fistula or graft, and also stabilise the arm during a haemodialysis session.. The intervention will be applied by the dialysis nursing staff, who will monitor its use for the duration of the dialysis session (usually 4-5 hours) and remove it at the end. The intervention period will involve use of the device for six consecutive haemodialysis sessions.
The DialyAssist device is a plastic device designed to secure the fistula arm, needles and tubing during dialysis that has been developed by a person with lived experience of hemodialysis.
Intervention code [1] 330394 0
Treatment: Devices
Comparator / control treatment
Participants will be their own controls. They will undergo outcome assessment after a period of usual care for 6 consecutive sessions in the control period. Usual care means securing the needles and tubing in the usual way with tape or other means but without using the novel DialyAssist device.
Control group
Active

Outcomes
Primary outcome [1] 340502 0
The Vascular Access Specific Quality of Life Measure (VASQoL)
Timepoint [1] 340502 0
The primary outcome will be assessed after six consecutive sessions of dialysis with needles and tubing secured by tapes or other means but not the DialyAssist device in the control period, and after six consecutive haemodialysis sessions using the DialyAssist device during the intervention period. The order in which participants do the intervention and control period will be randomised.
Secondary outcome [1] 444283 0
Proportion of participants who score less than 8 on Item 2 of the VASQoL.
Timepoint [1] 444283 0
This outcome will be assessed in participants at the end of their control period (six consecutive sessions of dialysis with needles and tubing secured by tapes or other means but not the DialyAssist device).

Eligibility
Key inclusion criteria
Adult patients receiving haemodialysis via an AVF (or graft)
Provision of informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of a dialysis catheter
Undergoing haemodialysis at home

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using computer software to generate randomisation to AB or BA, where A is the intervention and B is usual therapy
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Not strictly crossover, as participants will not be randomized to the order of using the device. Participants baseline data (before using the device) will serve as control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In the study validating the VASQoL, the median (IQR) score for Item 2 was 9 (Richarz, S, Greenwood, S, Kingsmore, DB, Thomson, PC, Dunlop, M, Bouamrane, M-M, Meiklem, R &
Stevenson, K 2021, 'Validation of a vascular access specific quality of life measure (VASQoL)', The Journal of Vascular Access (JVA), pp. 11297298211046746. https://doi.org/10.1177/11297298211046746). The null hypothesis is that the Item 2 score in patients will be unchanged between no device and using the device. The alternative hypothesis is that it will increase by 1 point between no device and using the device. In a previous study, the median score for this item was 9 and interquartile range 8-10. With power of 0.8 and accepting alpha less than or equal to 0.05, we would need 40 people to show such a difference. Difference in score on Item 2 between baseline and intervention will be compared using a paired Wilcoxon test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/06/2025
Actual
Date of last participant enrolment
Anticipated
24/11/2025
Actual
Date of last data collection
Anticipated
8/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27524 0
Eastern Health - Box Hill
Recruitment postcode(s) [1] 43637 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 318273 0
Hospital
Name [1] 318273 0
Eastern Health
Country [1] 318273 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 320660 0
None
Name [1] 320660 0
Address [1] 320660 0
Country [1] 320660 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316913 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 316913 0
Ethics committee country [1] 316913 0
Australia
Date submitted for ethics approval [1] 316913 0
12/05/2025
Approval date [1] 316913 0
Ethics approval number [1] 316913 0

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

Contacts
Principal investigator
Name 139414 0
A/Prof Matthew Roberts
Address 139414 0
Eastern Health Clinical School, Monash University, Level 2, 5 Arnold Street, Box Hill VIC 3128
Country 139414 0
Australia
Phone 139414 0
+61 3 90952410
Fax 139414 0
Email 139414 0
[email protected]
Contact person for public queries
Name 139415 0
Matthew Roberts
Address 139415 0
Eastern Health Clinical School, Monash University, Level 2, 5 Arnold Street, Box Hill VIC 3128
Country 139415 0
Australia
Phone 139415 0
+61 3 90952410
Fax 139415 0
Email 139415 0
[email protected]
Contact person for scientific queries
Name 139416 0
Matthew Roberts
Address 139416 0
Eastern Health Clinical School, Monash University, Level 2, 5 Arnold Street, Box Hill VIC 3128
Country 139416 0
Australia
Phone 139416 0
+61 3 90952410
Fax 139416 0
Email 139416 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:
• No requirements
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:
No end date
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.