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Optimising self-management in people living with chronic kidney disease (CKD:) The Kidney Health 4 Life program

A randomised controlled trial assessing the effectiveness of the Kidney Health for Life (KH4L) program in improving self-management in people living with chronic kidney disease at key stages.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000601639
Enrollment
395
Registered
2023-06-01
Start date
2023-08-14
Completion date
2024-05-28
Last updated
2024-09-23

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

Conditions

None listed

Brief summary

This randomized controlled trial (RCT) aims to evaluate the effectiveness of the Kidney Health for Life (KH4L) program in improving self-management for people living with chronic kidney disease (CKD), at two key stages: after diagnosis and prior to and after commencing dialysis. Participants will be stratified into two groups, (1) people who have been diagnosed with stage 1-4 CKD and (2) people who are preparing to commence or currently receive dialysis. Participants of both groups will then be randomised to receive the intervention (KH4L program) or standard support (control). Participants will be assessed at three time points, at baseline, week 6 and week 18 post randomisation. We hypothesise that (1) participants in intervention groups will show greater self-management behaviours, disease-related knowledge, self-efficacy, and psychological well-being than participants in the control groups and over time, and (2) disease related knowledge, self-efficacy, psychological well-being and selected sociodemographic variables will be predictors of self-management behaviours. We will also ask participants of the intervention groups to provide some general feedback on the intervention. While this will not be a specific outcome of the study, it will be useful to consider their feedback on how they found the intervention so as to provide guidance for future adjustments to the program, post study. Throughout the course of the study, we will monitor adherence to the intervention by monitoring usage of the KH4L online health hub and record attendance at group sessions. The research team will oversee module completion and activate reminders to those who are lagging on module completion.

Interventions

This study investigates the effectiveness of the Kidney Health 4 Life (KH4L) program intervention on participants' ability to implement self-management strategies versus a control group receiving Kidney Health Australia's 'standard support'. The study includes two groups: people who have been diagnosed with stage 1-4 CKD (diagnosis group) and people who are preparing to commence or have started dialysis (dialysis group). Participants from these two groups will be randomly allocated to the KH4L p

This study investigates the effectiveness of the Kidney Health 4 Life (KH4L) program intervention on participants' ability to implement self-management strategies versus a control group receiving Kidney Health Australia's 'standard support'. The study includes two groups: people who have been diagnosed with stage 1-4 CKD (diagnosis group) and people who are preparing to commence or have started dialysis (dialysis group). Participants from these two groups will be randomly allocated to the KH4L program (intervention) group or the standard support (control) group. Participants of both intervention groups (diagnosis and dialysis) will be required to spend 2-3 hours per week on the KH4L program for the duration of 6 weeks. They will receive a standard support call from the Kidney Health Australia Kidney Helpline and a peer support opportunity with a 'kidney buddy', who has lived experience and can provide social and emotional support, as well as share information, learning and practical experiences. The standard support call is an initial phone call of up to 30 minutes duration that will be scheduled with all participants within 3 weeks of completion of the baseline survey. Following the phone call, participants will be sent additional information and resources, including relevant factsheets and booklets, via email or post. The content covered in the support call will be in direct response to the questions and needs of the participant. Our team will listen to their concerns, respond to any questions they have and then direct them to appropriate information and resources on the Kidney Health Australia website. This may include links to relevant website content, the provision of factsheets or booklets via email or post and also referral or recommendations of third-party resources and services that may be beneficial for them. The peer support opportunity will be offered during the standard support call, and, if the participant is interested in pursuing this opportunity, the process of matching them with an appropriate support person will commence. The peer support will start approximately 1-2 weeks after the standard support call and will involve an initial call of 15 – 30 minutes duration with the Kidney Health Australia peer support team to discuss their situation and identify their specific needs for a peer support. From there, the Kidney Health Australia peer support team will arrange the buddy pairing and put the study participant and the ‘buddy’ in contact. The allocated buddy will arrange a time for a phone support session of approximately 1-hour duration. Additional meetings or further peer support beyond this call is at the discretion of the buddy pairing and the specific needs of the participant. In addition to the scheduled support, the participants will be able to contact our Kidney Helpline team as needed throughout the study period. Intervention group participants will also be enrolled in a 6-week online course, covering the following module topics: (1) Improve your knowledge about your kidney disease by finding and using evidence-based information, (2) Adopt positive health behaviours to improve or maintain kidney health, (3) Know how food choices impact your kidney health and incorporate these into your daily food planning, (4) Incorporate physical activity into your daily life, (5) Establish routines and strategies to improve sleep, stress and wellbeing, (6) Gain confidence to explain your kidney disease to others and seek support when needed. Topics will be presented in various formats, including webinars, videos, goal-setting activities and quizzes. We anticipate that participants will spend 2-3 hours per week to complete the online modules. All content development and delivery will be overseen by The KH4L Expert Reference Panel comprised of subject matter experts (healthcare professionals) with minimum 10 years' experience in their field. Review by a consumer reference panel will also ensure that the content is appropriate to the target audience. We will monitor adherence to the intervention by monitoring usage of the KH4L online health hub. Phone calls and/or group session attendance will be recorded in the KH4L online hub by the facilitator. The research team will oversee module completion and activate reminders to those who are lagging on module completion. How the KH4L programs differ between the two groups (diagnosis and dialysis): - The content of the topics covered is specific to the needs experienced by the people in the individual groups. KH4L program - diagnosis group: Participants in this group will also be offered online group and/or a phone session with a renal dietitian, one phone session/online group session with a Health Coach on goal setting, maintaining motivation, practical changes and adherence to treatments and/or lifestyle changes. Group sessions will be with a maximum of 10 participants with one expert facilitator. KH4L program - dialysis group: Participants in this group will also be offered one phone session with a social worker/counsellor on managing stress and anxiety and one phone/online group session with the Health Coach on goal setting, managing life priorities and adherence to treatments and/or lifestyle changes. Group sessions will be with a maximum of 10 participants and one expert facilitator. Participants who are in the KH4L program groups will be asked to give us feedback on the intervention, via questions about what they liked best, least, what they would change about the program. We will also ask questions about their thoughts on the length and level of support received. Furthermore, the participant’s usage of the KH4L online health hub will be monitored and aspects such as, the number of times a participant is logging in to the KH4L hub, the amount of time spent on the KH4L hub on each occasion, and whether participants complete modules will be recorded.

Sponsors

Kidney Health Australia
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Participants will be adults with a diagnosis of CKD, who fit into one of the following groups: (1) Individuals who have been diagnosed with early to mid-stage CKD (stages 1-4). (2) Individuals who are preparing to commence or currently receive dialysis.

Exclusion criteria

People who are unable to read and understand English. People who do not have access to a computer or other device for completing the online modules and questionnaires. People who do not have an email address. Participants located outside of Australia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026