Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000136404
Ethics application status
Approved
Date submitted
24/06/2024
Date registered
6/02/2025
Date last updated
6/02/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a co-designed self-management program for adults with chronic kidney disease
Scientific title
Feasibility and Acceptability of a Co-designed Self-Management Program designed to empower adults with chronic kidney disease
Secondary ID [1] 311474 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 332791 0
Condition category
Condition code
Renal and Urogenital 329514 329514 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research team, renal consumers, and health professionals have co-developed a 12-week self-management program titled "Self-Management of Kidney Disease Program (SManage-KD)."

This program will be led by Nephrology Nurse Practitioners (NNPs), who will use a motivational interview approach.

In weeks 1 and 12 of this program, the participants will meet face-to-face in the renal outpatient clinic for approximately 60 minutes each session.

In weeks 3 and 6, the NNP will contact the participants over the phone (30 minutes each) to discuss educational activities, set patient goals, and develop an action plan.

In week 9, we plan to organise a 2-hour group session with up to 10 participants per group. Renal consumers receiving renal replacement therapies will be invited to this meeting to share their journey living with kidney disease and discuss practical ways of making health choices. Simple scenarios will be discussed to help participants become more independent in self-managing their health. Multidisciplinary renal team members will also be invited to participate in this group session. 

Participants will be given a choice of digital (utilising the Personify Care platform) or paper format (workbook); both formats will have the same information and activities to complete the weekly educational activities such as medication/dietary adherence, symptoms and physical activity. The content (digital and paper format) was explicitly co-developed for this project and will have the same content.

The five sessions of this program are:
-Session 1 (week 1): We will discuss how kidneys work. In this session, the nurse will provide an overview of the program and meeting schedule, the concept of partnership and coaching, how to live with kidney disease (challenges / difficulties), and setting up two individual goals with an action plan for the following two weeks.
-Session 2 (week 3): This session will consist of an overview of chronic kidney disease, an introduction and recap of the previous session, a review of the two goals and action plan discussed in week 1, and a discussion about the burden of CKD symptoms.
-Session 3 (week 6): Consists of a discussion about "What can be done to improve kidney health", a review of the two individual goals and action plan from the previous session, and a discussion about how to become independent to manage CKD.
-Session 4 (week 9): The group session will consist of a discussion about "Practical ways to make healthy choices" and "Self-management of CKD symptoms" using basic clinical scenarios to discuss problem-solving situations.
-Session 5 (week 12): Consists of a review of the previous sessions, discusses the concept of self-advocacy, where to find trustable information about kidney disease and discusses the Preparing for dialysis toolkit already used by the renal service.

Digital Patient Pathways is a Personify Care mobile platform used by Local Health Networks across SA Health to exchange information with patients about their care. Personify Care provides a unique opportunity for researchers to capture patient-reported data at scale to support research activities and evaluate population-level models of care. The Personify Care platform consists of two end-user components: 1) a Clinical Dashboard clinicians use to configure clinical pathways, detect patients' risks early, record early interventions, and review patient progress; and 2) a Patient Checklist used by patients to follow their personalised pathway.
Intervention code [1] 328973 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337310 0
Determine the clinical feasibility in usual kidney care service of this co-designed self-management program among patients with CKD stage 5 not receiving dialysis
Timepoint [1] 337310 0
Outcomes will be assessed at baseline, weeks 3, 6, 9 and 12.
Primary outcome [2] 340514 0
Determine the clinical acceptability in usual kidney care service of this co-designed self-management program among patients with CKD stage 5 not receiving dialysis
Timepoint [2] 340514 0
Week 12 - end of the study
Secondary outcome [1] 443456 0
patient activation
Timepoint [1] 443456 0
Week 1 and week 12

Eligibility
Key inclusion criteria
•18 years old and over
•English speaking
•Diagnosed with chronic kidney disease stage 5 (eGFR less than or equal to 15 ml/min/1.73 m2)
•Attending outpatient setting
•Receiving care by the kidney care team in CNARTS.
•Willing and able to give informed consent and comply with the study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Unable to give written consent.
•Inability or unwillingness to complete patient self-management program (e.g., due to literacy, vision impairment, cognitive deficits)
•Significant disease or disorder that, in the opinion of the patient’s own renal clinician, may either put the participation at risk because of participation in the study or may influence the result of the study of the participant’s ability to participate in the study
•Already receiving dialysis
•Following conservative renal management.
•Acute kidney injury

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
14/04/2025
Actual
Date of last data collection
Anticipated
14/07/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26149 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 26150 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 42010 0
5000 - Adelaide
Recruitment postcode(s) [2] 42011 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 315758 0
Charities/Societies/Foundations
Name [1] 315758 0
Kidney, Transplant & Diabetes Research Australia (KTDRA)
Country [1] 315758 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network (CALHN)
Address
Country
Australia
Secondary sponsor category [1] 317881 0
None
Name [1] 317881 0
Address [1] 317881 0
Country [1] 317881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314621 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 314621 0
Ethics committee country [1] 314621 0
Australia
Date submitted for ethics approval [1] 314621 0
04/03/2024
Approval date [1] 314621 0
09/04/2024
Ethics approval number [1] 314621 0
CALHN Reference Number: 19031
Ethics committee name [2] 315578 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 315578 0
Ethics committee country [2] 315578 0
Australia
Date submitted for ethics approval [2] 315578 0
16/05/2024
Approval date [2] 315578 0
18/06/2024
Ethics approval number [2] 315578 0
Application ID: 206246

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

Contacts
Principal investigator
Name 132190 0
Dr Laura E. Lunardi
Address 132190 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000
Country 132190 0
Australia
Phone 132190 0
+61882228072
Fax 132190 0
Email 132190 0
[email protected]
Contact person for public queries
Name 132191 0
Laura Lunardi
Address 132191 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000
Country 132191 0
Australia
Phone 132191 0
+61882228072
Fax 132191 0
Email 132191 0
[email protected]
Contact person for scientific queries
Name 132192 0
Laura Lunardi
Address 132192 0
Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000
Country 132192 0
Australia
Phone 132192 0
+61882228072
Fax 132192 0
Email 132192 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:
• researchers who provide a methodologically sound proposal. After publication, the data will shared to anyone

Conditions for requesting access:
• -

What individual participant data might be shared?
• findings of the study

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Data will be available for 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator Laura Lunardi
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Protocol_SManage_KDProgram.pdf


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.