Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000577314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/11/2025
Date registered
Help: Date registered
7/05/2026
Date last updated
Help: Date last updated
7/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The CONTINUUM project: Coordination of Long-Term Rehabilitation for Indigenous Patients to Improve Quality of Life and Outcomes
Scientific title
Coordination of Long-Term Rehabilitation for Indigenous Patients to Improve Quality of Life and Outcomes
Additional trial identifiers [1] 315692 0
MRF2025027
Universal Trial Number (UTN)
U1111-1330-4324
Trial acronym
The CONTINUUM project
Related trial records

Health condition
Health condition(s) studied:
Chronic disease 339394 0
Coronary Artery Disease 339865 0
Heart Failure 339866 0
Ischemic stroke 339867 0
Intracerebral haemorrhage 339868 0
Subarachnoid haemorrhage 339869 0
Type 2 Diabetes-related Foot complications 339870 0
Type 2 Diabetes-related Renal complications 339871 0
Condition category
Condition code
Cardiovascular 335642 335642 0 0
Coronary heart disease
Stroke 335643 335643 0 0
Haemorrhagic
Stroke 335644 335644 0 0
Ischaemic
Renal and Urogenital 335645 335645 0 0
Kidney disease
Physical Medicine / Rehabilitation 335647 335647 0 0
Other physical medicine / rehabilitation
Metabolic and Endocrine 336016 336016 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants in the intervention group will receive Navigator support for 12 months. A Navigator is someone from the health service, who can help support your rehabilitation journey by attending therapy appointments with you, helping with any questions that you have and going through your health care information with you, such as your medication plan.

Patient Navigators are a relatively new and promising role to help patients with chronic diseases and long-term conditions navigate the complexities of the health care system.

A non-clinical patient navigator provides practical, cultural, and emotional support to individuals throughout their rehabilitation journey, helping them overcome system barriers, coordinate services, and stay engaged in their care. By acting as a consistent point of connection between the patient, their family, and the wider care team, the navigator ensures that the rehabilitation pathway feels more accessible, supported, and tailored to the person’s needs.

Aboriginal and Torres Strait Islander patients with chronic disease who are inpatients at the Royal Adelaide Hospital in South Australia will be invited to take part in the study.

Eligible participants will be randomised in a 1:1 ratio to receive a 12-month program of Navigator support (intervention) or usual care (control group). Participants assigned to the intervention group will receive additional ongoing support in the form of coordinated care for their rehabilitation throughout the 12-month post-discharge period.

Throughout the year, everyone will receive usual care and treatment appropriate to their chronic condition.

Usual pathways of care for each individual, including multi-disciplinary rehabilitation program content, is guided by the associated clinical care Standards and Guidelines for each chronic condition in the areas of cardiac, stroke, Type 2 Diabetes-related foot complications and Type 2 Diabetes-related renal complications.

All care required, whether physical, social or emotional is to be determined and discussed between the participant and their treating general practitioner, rehabilitation care providers and/or treating physician/s. Navigators will support participants to implement their individual rehabilitation plans, through care coordination including education; engagement with health care system navigation; promote patient understanding of their rehabilitation plan and work with participants and care providers to improve access and address barriers affecting access or adherence.

Participants in the Navigator support (intervention) group will receive additional support and care coordination of their personalised rehabilitation program over and above the usual pathways of care. Participants in the Intervention group will be supported by rehabilitation care Navigators to assist implementation of their individual rehabilitation care plan, with additional ad-hoc support as required throughout the 12 month intervention period and reviews to occur as follows: first consultation prior to discharge from hospital, with the second consultation occurring within the first month post-discharge, then consultations at 3 months, 6 months and 12 months. Participants in the intervention group will have study visits and complete questionnaires at baseline (in-hospital), at 2 weeks, 3 months, 6 months and 12 months.

Participant visits will be conducted face-to-face, online or by phone as needed.

Navigator activity logs will be utilised to measure occasions and mode of service provided by the Navigator.

All participants will receive updates through a regular newsletter.

Optional activities in the project include participation in focus groups and/or interviews during the study and/or after participation in the study.
Intervention code [1] 332313 0
Rehabilitation
Intervention code [2] 332314 0
Lifestyle
Intervention code [3] 333854 0
Other interventions
Description of the comparator or control
Usual care

Participants in the Usual Care (control) group will receive the usual rehabilitation care after leaving hospital and will receive usual care from their healthcare team.

Usual care including rehabilitation program content is guided by the associated clinical care Standards and Guidelines for each chronic condition in the areas of cardiac, stroke, Type 2 Diabetes-related foot complications and Type 2 Diabetes-related renal complications.

Participants in the Usual Care group will have study visits and complete questionnaires at baseline (in-hospital), 3 months, 6 months and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 343196 0
Quality of Life
Timepoint [1] 343196 0
baseline, 3 months, 6 months and 12 months post-intervention commencement
Secondary outcome [1] 453617 0
Number of repeat hospitalisations
Timepoint [1] 453617 0
12 months post-intervention commencement
Secondary outcome [2] 454759 0
Survival status
Timepoint [2] 454759 0
12 month end of study visit
Secondary outcome [3] 454763 0
Out of pocket healthcare expenses
Timepoint [3] 454763 0
6 months and 12 months post-intervention commencement
Secondary outcome [4] 454764 0
Navigator Activity
Timepoint [4] 454764 0
From baseline to 12 months post-intervention commencement for each navigator contact
Secondary outcome [5] 457726 0
Wellbeing
Timepoint [5] 457726 0
baseline, 3 months, 6 months and 12 months post-intervention commencement
Secondary outcome [6] 457872 0
Number of days in hospital
Timepoint [6] 457872 0
12 months post-intervention commencement

Eligibility
Key inclusion criteria
1. Self-identify as Aboriginal and/or Torres Strait Islander
2. Age 18 years or over
3. Able to provide informed consent
4. Inpatient at the Royal Adelaide Hospital with one or more of the following chronic conditions:
i) Coronary Artery Disease or Heart Failure
ii) Stroke (ischemic stroke, intracerebral haemorrhage or subarachnoid haemorrhage)
iii) Type 2 Diabetes-related Foot complications: below, through or above knee amputation, midfoot (minor) amputation, toe(s) amputation for diabetes, toe (1-5 toes) or ray amputation
iv) Type 2 Diabetes-related Renal complications: estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2 and not on renal replacement therapy
5. Individuals for whom their clinical team deem specialised rehabilitation to be most appropriate
6. Usual place of residence geographically located in one of the participating areas
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Unable to give informed consent
2. Participation in the study is considered inappropriate for the patient at this time

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer (SAHMRI REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
1/07/2026
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28700 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 44933 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 320294 0
Government body
Name [1] 320294 0
NHMRC MRFF
Country [1] 320294 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health & Medical Research Institute
Address
Country
Australia
Secondary sponsor category [1] 322868 0
None
Name [1] 322868 0
Address [1] 322868 0
Country [1] 322868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318838 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 318838 0
Ethics committee country [1] 318838 0
Australia
Date submitted for ethics approval [1] 318838 0
31/10/2025
Approval date [1] 318838 0
08/04/2026
Ethics approval number [1] 318838 0
Ethics committee name [2] 318847 0
Central Adelaide Local Health Network HREC
Ethics committee address [2] 318847 0
Ethics committee country [2] 318847 0
Australia
Date submitted for ethics approval [2] 318847 0
24/11/2025
Approval date [2] 318847 0
Ethics approval number [2] 318847 0

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

Contacts
Principal investigator
Name 145426 0
A/Prof Kim Morey
Address 145426 0
Wardliparingga Aboriginal Health Equity Theme, South Australian Health & Medical Research Institute (SAHMRI), North Terrace, Adelaide, SA 5000
Country 145426 0
Australia
Phone 145426 0
+61 881284230
Fax 145426 0
Email 145426 0
[email protected]
Contact person for public queries
Name 145427 0
Kim Morey
Address 145427 0
Wardliparingga Aboriginal Health Equity Theme, South Australian Health & Medical Research Institute (SAHMRI), North Terrace, Adelaide, SA 5000
Country 145427 0
Australia
Phone 145427 0
+61 881284230
Fax 145427 0
Email 145427 0
[email protected]
Contact person for scientific queries
Name 145428 0
Kim Morey
Address 145428 0
Wardliparingga Aboriginal Health Equity Theme, South Australian Health & Medical Research Institute (SAHMRI), North Terrace, Adelaide, SA 5000
Country 145428 0
Australia
Phone 145428 0
+61 881284230
Fax 145428 0
Email 145428 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.