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Behavioural change strategy for managing interdialytic weight gain in haemodialysis treated patients.

The use of a volitional help sheet for managing interdialytic weight gain in patients with kidney failure undergoing haemodialysis: A cluster randomised controlled trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000703505
Enrollment
125
Registered
2024-06-04
Start date
2024-06-24
Completion date
2024-10-07
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this project is to determine how effective behavioural change strategies are in managing fluid amongst people who are receiving haemodialysis treatment for their kidney disease. Fluid management is important during dialysis because having too much fluid can cause high blood pressure, swelling, breathing difficulties and high weight gain, which can then lead to increased hospitalisation and mortality. Behavioural change strategies have been successfully used in previous research for helping participants to manage other health related behaviours, such as reducing unhealthy snacking, however they have never been used to help manage fluids in patients on haemodialysis treatment. This project aims to address this gap in the research.

Interventions

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

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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026