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Trial registered on ANZCTR


Registration number
ACTRN12624000703505p
Ethics application status
Submitted, not yet approved
Date submitted
23/05/2024
Date registered
4/06/2024
Date last updated
4/06/2024
Date data sharing statement initially provided
4/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural change strategy for managing interdialytic weight gain in haemodialysis treated patients.
Scientific title
The use of a volitional help sheet for managing interdialytic weight gain in patients with kidney failure undergoing haemodialysis: A cluster randomised controlled trial.
Secondary ID [1] 312202 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney disease 333877 0
Condition category
Condition code
Renal and Urogenital 330551 330551 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a volitional help sheet (VHS) that links “if” and “then” behaviours relating to fluid intake. Participants will choose at least one of five common “if” situations, including “I am often tempted to drink too much fluid” when “I am thirsty”, “I am out with other people” and/or “I have had too much salt in my diet”. Participants will make their plan by linking an “if” behaviour such as “If I'm tempted to drink a lot of fluid because I am thirsty, then I will” to a “then” behaviour such as “only have half a cup of drink” or “suck on a few ice cubes and limit this to one cup per day”. The VHS will be presented to consenting participants, in paper format by the research team, who have been allocated to the intervention group following recruitment. Participants will create this plan with the assistance of a researcher, and is expected to take 30 minutes to complete. The total duration of the intervention is 12 weeks. All participants will be provided with an information sheet, that is designed for this study, which consists of a fluid intake log that participants can use to track their fluid intake for the duration of the intervention. Researchers will check-in with participants at weeks four and eight to remind them of their if-then plans, and to check on their progress in using the plan. Participants who indicate that their plan is not working effectively, will be given the option to create a new plan. Participants who consent to be contacted by phone, will be sent a reminder text for the check-in. Alternatively, researchers may visit the study sites in person at weeks four and eight to check-in on participant progress.
The intervention will be delivered at each participating site during the participants normally scheduled haemodialysis sessions.
Intervention code [1] 328648 0
Behaviour
Comparator / control treatment
The active control group will receive usual care. they will not receive the Volitional Help Sheet to make a plan to control their fluid intake. The control group will receive the same information sheet for managing their fluids as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 338312 0
change in interdialytic weight gain
Timepoint [1] 338312 0
baseline, 4 weeks, 8 weeks, 12 weeks (primary timepoint) post intervention commencement
Secondary outcome [1] 435399 0
pre-dialysis systolic blood pressure
Timepoint [1] 435399 0
baseline, 4 weeks, 8 weeks, 12 weeks (primary timepoint) post intervention commencement
Secondary outcome [2] 435400 0
8-item behaviour survey
Timepoint [2] 435400 0
12 weeks post intervention commencement
Secondary outcome [3] 435401 0
8-item confidence survey
Timepoint [3] 435401 0
12 weeks post intervention commencement

Eligibility
Key inclusion criteria
Stage 5 chronic kidney disease.
Adults 18 years and over.
Receive haemodialysis treatment at least 3 times per week at participating sites.
Have high interdialytic weight gain (greater than 10% dry weight).
Basic English skills.
Willingness to provide informed consent and participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lacks capacity to provide informed consent as determined by the treating clinician.
Diagnosis of dementia or severe cognitive impairment.
Cannot read, write or speak English as the Volitional Help Sheet, behaviour and confidence surveys are only available in English.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
cluster randomisation of participants will be conducted using the Study Randomizer online tool. Cluster randomisation will be based on the days that participants receive haemodialysis treatment. At each dialysis site, days of the week (Monday, Wednesday and Friday vs Tuesday, Thursday and Saturday) will be randomly allocated to the intervention group. This method of randomisation has been chosen to prevent contamination, where participants in the control arm could be exposed to the intervention materials if dialysing in the same session as the participants in the intervention group. This approach has been adapted from previous RCTs in hospital dialysis settings.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We intend to recruit a sample size of 125 participants for this study to give us 80% power to detect a difference of 0.005kg of fortnightly interdialytic weight gain between the intervention and control groups. The sample size has been determined using the G*Power application, based on a previous study that used a behavioural regulation interventions in the field of kidney health. Data analysis will be carried out by researchers from the School of Public Health at the University of Sydney who will be blinded to participant allocation to intervention and usual care arms (control group).
An intention to treat analysis will be used to compare primary and secondary outcomes between the intervention and control groups. Descriptive statistics will be used to summarise baseline demographic data and to compare participant responses in the follow-up surveys measuring behaviours that participants engaged in to manage their fluids and how confidence for engaging in strategies for managing their fluid intake. Independent sample t-tests will be used to assess changes in pre- and post-intervention interdialytic weight gain and pre-dialysis systolic blood pressure. Linear regression models will be used to compare the overall difference in interdialytic weight gain between intervention and control groups, adjusting for dialysis treatment location, baseline weight, gender, age, postcode, and ethnicity.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2024
Actual
Date of last participant enrolment
Anticipated
7/10/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316578 0
University
Name [1] 316578 0
The University of Sydney
Country [1] 316578 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318758 0
None
Name [1] 318758 0
Address [1] 318758 0
Country [1] 318758 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315363 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 315363 0
Ethics committee country [1] 315363 0
Australia
Date submitted for ethics approval [1] 315363 0
16/05/2024
Approval date [1] 315363 0
Ethics approval number [1] 315363 0

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

Contacts
Principal investigator
Name 134470 0
Dr Danielle Muscat
Address 134470 0
127a Edward Ford Building (A27), The University of Sydney, Camperdown NSW, 2050
Country 134470 0
Australia
Phone 134470 0
+61 9351 7819
Fax 134470 0
Email 134470 0
Danielle.muscat@sydney.edu.au
Contact person for public queries
Name 134471 0
Danielle Muscat
Address 134471 0
127a Edward Ford Building (A27), The University of Sydney, Camperdown NSW, 2050
Country 134471 0
Australia
Phone 134471 0
+61 9351 7819
Fax 134471 0
Email 134471 0
Danielle.muscat@sydney.edu.au
Contact person for scientific queries
Name 134472 0
Danielle Muscat
Address 134472 0
127a Edward Ford Building (A27),The University of Sydney, Camperdown NSW, 2050
Country 134472 0
Australia
Phone 134472 0
+61 9351 7819
Fax 134472 0
Email 134472 0
Danielle.muscat@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23769Study protocol    387853-(Uploaded-23-05-2024-10-26-11)-Research Protocol Version 1.0.docx
23770Informed consent form    387853-(Uploaded-23-05-2024-10-26-26)-Participant information sheet and consent form version 1.0 dated 16 May 2024.pdf
23771Other    Volitional help sheet 387853-(Uploaded-23-05-2024-10-27-05)-VHS Final version 1.0 dated 16 May 2024.pdf
23772Other    Recruitment flyer 387853-(Uploaded-23-05-2024-10-27-27)-Recruitment flyer version 1.0 dated 16 May 2024.pdf
23773Other    Information about fluids pamphlet 387853-(Uploaded-23-05-2024-10-28-01)-Information about fluids version 1.0 dated 16 May 2024.pdf
23774Other    participant surveys 387853-(Uploaded-23-05-2024-10-28-19)-participant surveys version 1.0 dated 16 May 2024.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23769Study protocol    387853-(Uploaded-16-09-2024-09-55-26)-Research Protocol Version 2.0 dated 8 July 2024.docx
23770Informed consent form    387853-(Uploaded-16-09-2024-09-55-26)-PICF with provision for site PICF version 3.0 dated 29 August 2024.docx
23771Other    Volitional help sheet 387853-(Uploaded-16-09-2024-09-55-26)-VHS. Version 3.0. dated 29 August 2024.pdf
23772Other    Recruitment flyer 387853-(Uploaded-16-09-2024-09-55-26)-Flyer with provision for site flyer. Version 3.0 dated 29 August 2024.docx
23773Other    Information about fluids pamphlet 387853-(Uploaded-16-09-2024-09-55-26)-Information about fluids version 2.0 dated 08 July 2024 (2).pdf
23774Other    participant surveys 387853-(Uploaded-23-05-2024-10-28-19)-participant surveys version 1.0 dated 16 May 2024.pdf
New Record*Other    withdrawal of consent 387853-(Uploaded-16-09-2024-09-56-00)-Master Withdrawal of consent with site provision. Version 1.0. dated 08 July 2024.docx

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.