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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chronic kidney disease

Condition category

Condition code

Renal and Urogenital

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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

Assessment method [1]

Feasibility will be assessed as follows: (1) Eligibility – defined as the number of participants meeting eligibility criteria out of the total number of people attending the clinics; (2) recruitment—defined as the number of consenting participants as a proportion of those eligible; (3) retention—defined as the number of participants remaining in the trial as a proportion of those enrolled The feasibility of this program will be examined descriptively by presenting summary statistics for each of the feasibility criteria. Quantitative data will consist of descriptive measures as detailed and presented as means and averages or medians and interquartile ranges (IQR) as relevant. Data will be collected from the study database.

Timepoint [1]

Outcomes will be assessed at baseline, weeks 3, 6, 9 and 12.

Primary outcome [2]

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

Assessment method [2]

Acceptability—defined as participants' satisfaction with the program regarding seven items: finding information, intervention setting, program facilitator, setting and acting on attainable goals, self-monitoring, renal clinics attendance and phone calls. Each item will have five answer options, from 1 (“very little”) to 5 (“quite a lot”). Total scores will be obtained by summing the item responses, with higher scores indicating greater acceptance of the program. Acceptability will be also evaluated by asking the participants the following open-ended question: “Would you please share with us your experience and any suggestion for this program?”.

Timepoint [2]

Week 12 - end of the study

Secondary outcome [1]

patient activation

Assessment method [1]

Patient Activation Measure -13 (PAM-13) questionnaire

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

The Queen Elizabeth Hospital - Woodville

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5011 - Woodville

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Kidney, Transplant & Diabetes Research Australia (KTDRA)

Country [1]

Australia

Primary sponsor type

Government body

Name

Central Adelaide Local Health Network (CALHN)

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network HREC

Ethics committee address [1]

https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/03/2024

Approval date [1]

09/04/2024

Ethics approval number [1]

CALHN Reference Number: 19031

Ethics committee name [2]

University of South Australia Human Research Ethics Committee

Ethics committee address [2]

https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

16/05/2024

Approval date [2]

18/06/2024

Ethics approval number [2]

Application ID: 206246

Summary

Brief summary

Chronic kidney disease (CKD) is a progressive condition associated with reduced quality of life, high mortality, and healthcare costs. The chronicity of this disease necessitates individuals actively self-manage their health care to maximise health outcomes. The term ‘patient activation’ explicitly identifies the skills, knowledge and confidence that underpin a person’s willingness and ability to self-manage their health

Our recent survey of South Australian people with CKD stage 5 not receiving dialysis showed that most (73%) patients had low patient activation levels. Low patient activation levels were associated with more hospital emergency department visits and poor medication adherence. Given the current low patient activation levels, we co-designed with renal consumers and clinicians a Self-Management of Kidney Disease Program (S-Manage KD) that will be tested for feasibility and acceptability in this study.

This SManage-KD program could significantly increase engagement in positive health behaviours for a more active role in self-management in the CKD population. It is hoped that this newly developed SManage-KD Program will increase patients' ownership of care required to reduce the burden in the transition to dialysis initiation, improve treatment adherence, reduce hospital admissions rate, and ultimately, costs downstream in the CKD population. To assess these outcomes a new study to assess the effectiveness of this program is required.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Laura E. Lunardi

Address

Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000

Country

Australia

Phone

+61882228072

laura.lunardi@sa.gov.au

Contact person for public queries

Name

Laura Lunardi

Address

Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000

Country

Australia

Phone

+61882228072

laura.lunardi@sa.gov.au

Contact person for scientific queries

Name

Laura Lunardi

Address

Royal Adelaide Hospital, Port Road, Adelaide, South Australia 5000

Country

Australia

Phone

+61882228072

laura.lunardi@sa.gov.au

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
laura.lunardi@sa.gov.au

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
21966	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.

Trial Review

Documents added manually

Documents added automatically