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Trial registered on ANZCTR


Registration number
ACTRN12623000601639
Ethics application status
Approved
Date submitted
19/05/2023
Date registered
1/06/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
1/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising self-management in people living with chronic kidney disease (CKD:) The Kidney Health 4 Life program
Scientific title
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.
Secondary ID [1] 309694 0
None
Universal Trial Number (UTN)
U1111-1292-8335
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 330069 0
Condition category
Condition code
Renal and Urogenital 326969 326969 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326134 0
Behaviour
Comparator / control treatment
Participants in the standard support groups (control) will also receive a standard support call from Kidney Health Australia's Kidney Helpline and will be offered a peer support opportunity with a kidney buddy. Both activities are existing KHA programs and available to anybody in Australia. Participants in the standard support group will be offered access to the online learning modules once they have completed the study.

The standard support call is an initial phone call of up to 30 minutes duration that will be scheduled with all participants within 1-2 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.

Differences between the two control groups:
The two different groups (diagnosis and dialysis) will be provided with, advice that is specific to their personal needs and disease stage. Participants will be able to ask questions and have a discussion with our Kidney Helpline team and this will guide the information and advice provided. As part of the ‘standard’ support they will be directed resources and information that aligns with the support required. For the peer support component, they will also be paired with a buddy who has lived experience relevant to their group: i.e., experience living with chronic kidney disease or experience with dialysis.
Control group
Active

Outcomes
Primary outcome [1] 334813 0
Self-management will be measured using the validated Australian CKD Self-Management Instrument (Aus.CKD-SM).
Timepoint [1] 334813 0
Self-management will be assessed at three timepoints, at baseline (week 0), week 6 and week 18 post randomisation.
Secondary outcome [1] 422146 0
Disease related self-efficacy will be measured using the validated self-efficacy for managing chronic disease six item scale (SEMCD-6)
Timepoint [1] 422146 0
Self-efficacy will be assessed at three timepoints, at baseline - week 0, week 6 and week 18 post randomisation.
Secondary outcome [2] 422147 0
Disease related knowledge will be measured using the validated Kidney Knowledge Survey (KiKS).
Timepoint [2] 422147 0
Disease related knowledge will be assessed at three timepoints, at baseline - week 0, week 6 and week 18 post randomisation.
Secondary outcome [3] 422148 0
Participants’ psychological wellbeing will be measured using the validated Depression Anxiety Stress Scale (DASS-10).
Timepoint [3] 422148 0
Psychological wellbeing will be assessed at three timepoints, at baseline - week 0, week 6 and week 18 post randomisation.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
The person determining if a person is eligible to take part in the study will be unaware of which group they will be allocated to (intervention or control). Only after the person has provided consent will the participant be allocated to intervention/control group via central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are 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. Each of these two groups will then be randomly assigned to the intervention and control group - simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation): www.randomizer.org. A blocked design will be used to ensure equal numbers in the 2x2 groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to the nature of this project, the participants would find out which group they will be in, just by being part of it. For this reason, we decided to let them know their group allocation after they completed their baseline assessment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative Data:
Statistical analyses will be performed using statistical software packages such as STATA version 14. Data will be examined for quality and missing data and analysed using descriptive statistics with the appropriate assumptions of the test being checked. We will perform general linear mixed model for our analysis.

Qualitative data:
The data obtained from the open-ended questions will be analysed using manifest content analysis, a type of summative content analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2023
Actual
14/08/2023
Date of last participant enrolment
Anticipated
19/06/2024
Actual
28/05/2024
Date of last data collection
Anticipated
31/07/2024
Actual
31/07/2024
Sample size
Target
424
Accrual to date
Final
395
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 40407 0
3205 - South Melbourne
Recruitment postcode(s) [2] 40408 0
5067 - Kent Town

Funding & Sponsors
Funding source category [1] 313888 0
Charities/Societies/Foundations
Name [1] 313888 0
The Australian Kidney Foundation (t/a Kidney Health Australia)
Country [1] 313888 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Kidney Health Australia
Address
Kidney Health Australia
125 Cecil Street
South Melbourne
VIC 3205
Country
Australia
Secondary sponsor category [1] 315739 0
None
Name [1] 315739 0
Address [1] 315739 0
Country [1] 315739 0
Other collaborator category [1] 282683 0
University
Name [1] 282683 0
University of Wollongong
Address [1] 282683 0
A/Prof Kelly Lambert
University of Wollongong
Northfields Ave Wollongong
NSW 2522 Australia
Country [1] 282683 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313035 0
Research Ethics Unit at University of Wollongong
Ethics committee address [1] 313035 0
Research Ethics Unit at University of Wollongong
Northfields Ave Wollongong
NSW 2522
Ethics committee country [1] 313035 0
Australia
Date submitted for ethics approval [1] 313035 0
22/05/2023
Approval date [1] 313035 0
04/07/2023
Ethics approval number [1] 313035 0
2023/146

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126758 0
Ms Breonny Robson
Address 126758 0
Kidney Health Australia
Level 2, 18 Dequetteville Tce.
Kent Town
South Australia 5067
Country 126758 0
Australia
Phone 126758 0
+61 8 8334 7504
Fax 126758 0
Email 126758 0
[email protected]
Contact person for public queries
Name 126759 0
Katrin Buerkle
Address 126759 0
Kidney Health Australia
Level 2, 18 Dequetteville Tce,
Kent Town
South Australia 5067
Country 126759 0
Australia
Phone 126759 0
+61 8 8334 7503
Fax 126759 0
Email 126759 0
[email protected]
Contact person for scientific queries
Name 126760 0
Katrin Buerkle
Address 126760 0
Kidney Health Australia
Level 2, 18 Dequetteville Tce.
Kent Town
South Australia 5067
Country 126760 0
Australia
Phone 126760 0
+61 8 8334 7503
Fax 126760 0
Email 126760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study will collect survey responses, sociodemographic details and health-related data. To protect the privacy and confidentiality of participants, no individual participant data will be made available to the public or for sharing.


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.