Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001330336p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
2/10/2026
Date registered
Help: Date registered
4/11/2026
Date last updated
Help: Date last updated
4/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/11/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Social prescribing program for adults receiving dialysis
Scientific title
A pilot feasibility randomised controlled trial of a social prescribing program in adults receiving dialysis
Additional trial identifiers [1] 318571 0
Nil
Universal Trial Number (UTN)
Trial acronym
CONNECTeD
Related trial records

Health condition
Health condition(s) studied:
Kidney failure treated with dialysis 343722 0
Loneliness 343723 0
Social Isolation 343724 0
Condition category
Condition code
Renal and Urogenital 339836 339836 0 0
Kidney disease
Public Health 339837 339837 0 0
Health service research
Mental Health 339838 339838 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
A link worker social prescribing program.

Who delivers it: The intervention will be delivered by two link workers with lived experience of kidney failure. The link workers will be employees of the research host institution (University of Sydney).

Link worker training: Link worker training involves one online social prescribing course plus a three-day in-person program.

The online course is a self-paced course of approximately 2 hours duration developed by the World Health Organization (WHO). It is freely available via the WHO Academy website (https://whoacademy.org/course-discovery), and covers the principles and practice of social prescribing. Link workers will be instructed to complete this online course prior to attending the in-person training.

The three-day in-person training will be delivered by members of the research team including the lead investigator (a senior researcher with expertise in social prescribing), research assistant, and consumer researcher with lived experience of kidney failure. In-person training will run for approximately 4 hours per day over three days. In-person training will include educational sessions and interactive case studies covering: understanding dialysis; the role of the link worker; professional codes of conduct, including maintaining boundaries, privacy and confidentiality; reporting and managing incidents and complaints; and support available for link workers. In-person training will also include computer tutorials and practice of the use of Excel and REDCap. Any other gaps in knowledge identified by the link workers will be raised and addressed.

All training will take place after the link workers are recruited and will be completed 2 weeks prior to commencement of the social prescribing program.

Materials: A database of local social and community programs, activities and resources, held in Excel. The database will include activity name and category, provider name and contact details, registration/booking information, location, cost, frequency and mode of delivery (in person, online or telephone). In-person activities will initially be listed for Western Sydney close to the four participating sites, informed by patient interviews and input from activity providers. The database will be updated weekly by the research assistant with input from the link workers. Example activities include peer support and buddy programs, group social outings, online education workshops, community fitness classes and parkrun.

Procedures: (1) Initial consultation. Following randomisation, intervention group participants will be contacted by the link worker to organise the initial consultation. The initial consultation will be conducted in person or via telephone and will take approximately 45 minutes. At the initial consultation, the link worker will explain their role and assess the participant's social needs and priorities, as well as their capabilities and availability. The link worker will develop a joint plan and referral for the participant to attend or participate in a maximum of two social activities over the 3-month intervention period, in person or online. The link worker will also consult the treating physician to ensure that the chosen activities are regarded as safe for the participant (e.g. physical activity), and medical clearance will be obtained where necessary. The plan will be shared with a family member or carer nominated by the participant, who can offer encouragement and support. (2) Follow-up. The link worker will provide follow-up phone calls once per week for the first month, then once per fortnight over the remaining two months of the intervention, providing a maximum of 8 follow-up calls. Each follow-up call will take approximately 30 minutes. Support will be tailored to the needs of the individual participant and is expected to fall into one of four categories: informational (supplying information on resources), instrumental (e.g. making an appointment on behalf of a participant), appraisal (helping participants to make changes using behaviour change techniques, such as motivational interviewing) or emotional (listening and encouraging when participants face challenges). All link worker activity will be captured in a link worker logbook, including details of the initial consultation, priority aspects of social health and wellbeing, community resources referred to and attended, number and duration of follow-up calls, and type of support provided. Fidelity, dose and reach will be reported in the embedded process evaluation.

Intervention duration: 3 months from the initial consultation. Participants will complete outcome assessment questionnaires at baseline, end of intervention (month 3) and post-intervention (month 12).
Intervention code [1] 335426 0
Lifestyle
Intervention code [2] 335427 0
Behaviour
Description of the comparator or control
Usual care. Participants in the control group will receive usual care as per the Standard Operating Procedures of the Western Renal Service and will not be offered the link worker program. Study visits will only assess outcomes. For the purposes of this study, usual care is defined as follows. Patients who have an elective start to dialysis usually receive pre-dialysis education in group and/or one-on-one settings, and may be referred to allied health staff, including a social worker, to address concerns such as applications for resources from Centrelink or My Aged Care. Patients who have an urgent start to dialysis are reviewed by the nephrologist and referred to allied health teams if required. Patients receiving facility-based haemodialysis are cared for by haemodialysis nurses on shift each time they attend dialysis and receive blood tests every 2 months. Patients receiving home-based dialysis (peritoneal dialysis or home haemodialysis) are cared for by specialised home therapies nurses and receive blood tests and other monitoring every 3 months at minimum, with more frequent testing determined by clinical need; they may request urgent drop-in clinic review and can call a 24-hour on-call phone line for support. All patients see their nephrologist on average every 3 months for regular review.
Control group
Active

Outcomes
Primary outcome [1] 347010 0
Feasibility: recruitment rate, the percentage of eligible participants who consent. A recruitment rate of 50% or more of eligible participants will be considered indicative of study feasibility.
Timepoint [1] 347010 0
At close of recruitment.
Primary outcome [2] 347017 0
Feasibility: retention rate, the percentage of participants who remain enrolled in the study at 3 months. A retention rate of 80% or more at 3 months will be considered indicative of study feasibility.
Timepoint [2] 347017 0
End of intervention (month 3).
Primary outcome [3] 347018 0
Feasibility: data completeness, the percentage of participants with complete patient-reported outcome measures.
Timepoint [3] 347018 0
End of intervention (month 3) (primary timepoint) and post-intervention outcome assessment (month 12).
Secondary outcome [1] 468555 0
Feasibility: follow-up completion, the percentage of scheduled weekly/fortnightly follow-up calls completed (intervention group only). This is a primary feasibility outcome in the study protocol.
Timepoint [1] 468555 0
End of intervention (month 3).
Secondary outcome [2] 468556 0
Loneliness
Timepoint [2] 468556 0
Baseline, end of intervention (month 3) and post-intervention outcome assessment (month 12).
Secondary outcome [3] 468557 0
Social isolation
Timepoint [3] 468557 0
Baseline, end of intervention (month 3) and post-intervention outcome assessment (month 12).
Secondary outcome [4] 468558 0
Life participation
Timepoint [4] 468558 0
Baseline, end of intervention (month 3) and post-intervention outcome assessment (month 12).
Secondary outcome [5] 468559 0
Fatigue
Timepoint [5] 468559 0
Baseline, end of intervention (month 3) and post-intervention outcome assessment (month 12).
Secondary outcome [6] 468560 0
Hospitalisation: number of hospital admissions.
Timepoint [6] 468560 0
End of intervention (month 3) and post-intervention outcome assessment (month 12).
Secondary outcome [7] 468561 0
Technique survival
Timepoint [7] 468561 0
End of intervention (month 3) and post-intervention outcome assessment (month 12).
Secondary outcome [8] 468828 0
Mortality
Timepoint [8] 468828 0
End of intervention (month 3) and post-intervention outcome assessment (month 12).
Secondary outcome [9] 468838 0
Process evaluation: barriers and enablers for acceptance and uptake of the program. This is a composite outcome.
Timepoint [9] 468838 0
Intervention group participants: at baseline, within 1 week after randomisation and prior to the initial link worker consultation; and at the end of intervention (month 3). Link workers: at the mid-point of the intervention (1.5 months into the 3-month intervention period) and at the end of intervention (month 3). Dialysis clinic staff and community service providers: at the end of intervention, once the last participant has completed the 3-month intervention.
Secondary outcome [10] 468839 0
Economic evaluation: costs of delivering and participating in the intervention. This is a composite outcome.
Timepoint [10] 468839 0
End of intervention (month 3) and post-intervention outcome assessment (month 12).

Eligibility
Key inclusion criteria
1. Adults aged 18 years or older
2. Have been on dialysis (in-centre haemodialysis, home haemodialysis or peritoneal dialysis) for more than three months
3. Able to speak English
4. Able to provide informed voluntary consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Life expectancy of less than 6 months
2. Likely to receive a kidney transplant within 6 months

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)
Allocation is concealed. After a participant has given consent and been confirmed eligible, the research assistant obtains the allocation from an independent central web-based randomisation system. The allocation is not known to recruiting staff before enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer-generated random number sequence, 1:1.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
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
1/04/2027
Actual
Date of last participant enrolment
Anticipated
1/03/2028
Actual
Date of last data collection
Anticipated
1/03/2029
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 30280 0
Westmead Hospital - Westmead
Recruitment hospital [2] 30281 0
Auburn Hospital & Community Health Services - Auburn
Recruitment hospital [3] 30282 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 30283 0
Mount Druitt Hospital - Mount Druitt
Recruitment postcode(s) [1] 46683 0
2145 - Westmead
Recruitment postcode(s) [2] 46684 0
2144 - Auburn
Recruitment postcode(s) [3] 46685 0
2148 - Blacktown
Recruitment postcode(s) [4] 46686 0
2770 - Mount Druitt

Funding & Sponsors
Funding source category [1] 323111 0
Government body
Name [1] 323111 0
Department of Health, Disability and Ageing, Medical Research Future Fund Early to Mid-Career Researchers Grant Scheme
Country [1] 323111 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 326058 0
None
Name [1] 326058 0
Address [1] 326058 0
Country [1] 326058 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321505 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 321505 0
Ethics committee country [1] 321505 0
Australia
Date submitted for ethics approval [1] 321505 0
30/10/2026
Approval date [1] 321505 0
Ethics approval number [1] 321505 0

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

Contacts
Principal investigator
Name 153930 0
Dr Karine Manera
Address 153930 0
Centre for Kidney Research, Level 5 Block K, Westmead Hospital, 176 Hawkesbury Road, Westmead NSW 2145
Country 153930 0
Australia
Phone 153930 0
+61448716841
Fax 153930 0
Email 153930 0
[email protected]
Contact person for public queries
Name 153931 0
Karine Manera
Address 153931 0
Centre for Kidney Research, Level 5 Block K, Westmead Hospital, 176 Hawkesbury Road, Westmead NSW 2145
Country 153931 0
Australia
Phone 153931 0
+61448716841
Fax 153931 0
Email 153931 0
[email protected]
Contact person for scientific queries
Name 153932 0
Karine Manera
Address 153932 0
Centre for Kidney Research, Level 5 Block K, Westmead Hospital, 176 Hawkesbury Road, Westmead NSW 2145
Country 153932 0
Australia
Phone 153932 0
+61448716841
Fax 153932 0
Email 153932 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.