Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000612415
Ethics application status
Approved
Date submitted
21/05/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a vision assessment and referral model (VA-RIS) for people in rehabilitation after stroke or fracture at the University of Canberra Hospital
Scientific title
A randomised controlled trial evaluating the impact of a comprehensive vision assessment and referral model (VA-RIS) on quality of life, falls risk, and care planning in patients undergoing rehabilitation following stroke or fracture
Secondary ID [1] 314226 0
None
Universal Trial Number (UTN)
Trial acronym
VA-RIS Phase 2B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls-related fractures rehabilitation 337131 0
stroke rehabilitation 337130 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333554 333554 0 0
Other physical medicine / rehabilitation
Stroke 333986 333986 0 0
Haemorrhagic
Stroke 333987 333987 0 0
Ischaemic
Injuries and Accidents 333985 333985 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the Vision Assessment Referral, Investigation and Support (VA-RIS) pathway, a structured optometry-led assessment designed for patients admitted to the University of Canberra Hospital (UCH) for rehabilitation following stroke or falls-related fractures.

Within the first 1–3 weeks of admission, participants randomised to the intervention group first complete a set of quality-of-life questionnaires including the EuroQOL-5D-3L (EQ-5D), Impact of Vision Impairment (IVI), and the National Eye Institute Visual Function Questionnaire (NEI VFQ-25), which are administered in a separate session by a research assistant. The questionnaire session is expected to take approximately 30 minutes, depending on the participant’s pace and support needs.

At a separate session within the same 1–3 week timeframe, participants undergo a comprehensive vision assessment conducted face-to-face by final-year optometry students from the University of Canberra, under the supervision of ACT Health-credentialed optometrists. The assessment is consistent with standard of care routinely delivered in optometry clinics. The specific tests administered are determined by clinical judgement, taking into account each patient’s history, presentation, and physical or cognitive capacity. Where feasible, the assessment aims to include at minimum: habitual distance and near visual acuity testing (unaided and/or with current spectacles), confrontation visual fields, Amsler grid testing, contrast sensitivity (e.g. Pelli Robson Chart), and objective refraction. However, as with routine optometric care, the actual tests may vary depending on the patient’s condition and tolerance. Additional tests, such as ocular motility, saccades and pursuits, near point of convergence (NPC), near point of accommodation (NPA), cover testing, pupil reactions, binocular vision assessment (e.g. stereopsis, heterophoria), colour vision testing (e.g. Ishihara or UNSW SOVS Suite), intraocular pressure (e.g. Perkins tonometry), and ocular health evaluation (e.g. slit lamp examination, fundoscopy, or portable OCT), may be included where clinically appropriate. Bedside assessments and simplified materials may be used for patients with mobility or cognitive limitations. Where appropriate, the assessment also captures patient-reported or observed functional difficulties, such as reading, face recognition, and mobility-related visual challenges. The vision assessment is expected to be conducted within a 60-minute timeframe, during which as many relevant components as feasible will be completed based on the patient’s condition and tolerance.

Findings are recorded using a standardised clinical form and entered into the hospital’s Digital Health Record (DHR). A written report summarising clinical findings and recommendations (e.g. environmental modifications, low vision aids, or onward referrals) is provided to the treating rehabilitation team, along with an in-system notification. The clinical recommendations are intended to inform patient care during the inpatient rehabilitation stay at UCH and may also remain relevant post-discharge. However, their application is determined by the treating rehabilitation team, who integrate this information with other clinical findings to make holistic decisions. The vision assessment contributes to multidisciplinary care planning, but the research team does not control how the recommendations are used in practice.


Within 14 days of discharge, participants complete a follow-up assessment that includes the same set of quality-of-life questionnaires, again administered by a research assistant.

Within 6–8 weeks post-discharge, a second follow-up is conducted at UCH. This includes repeated administration of the same quality-of-life measures by the research assistant, and a brief reassessment of visual function (e.g. visual acuity, visual fields, and ocular health), where feasible, conducted by final-year optometry students from the University of Canberra under the supervision of ACT Health-credentialed optometrists. These follow-ups contribute to the evaluation of patient outcomes and the sustained impact of the intervention. The anticipated duration of this follow-up assessment is approximately 60 minutes.
Intervention code [1] 330837 0
Early detection / Screening
Comparator / control treatment
Participants in the control group will receive usual care, which refers to the standard rehabilitation pathway provided to patients admitted to the University of Canberra Hospital (UCH) for stroke or falls-related fractures. Patients in the Usual Care arm do not receive a scheduled in-reach optometry assessment after admission. Vision-related issues may be addressed only if identified incidentally by the medical or allied health team, with referrals to external providers (e.g. UC Health Hub, ophthalmology clinics) made on a case-by-case basis at the discretion of the treating team.

No structured vision assessment, report, or formalised communication is provided to the rehabilitation team by the study investigators. Participants in the Usual Care arm still complete the same outcome assessments as the intervention group (e.g. quality-of-life questionnaires and follow-up contacts), but no active vision intervention is delivered as part of the study protocol.
Control group
Active

Outcomes
Primary outcome [1] 341134 0
General health-related quality of life
Timepoint [1] 341134 0
Baseline (admission), discharge, and 6–8 weeks post-discharge
Primary outcome [2] 341135 0
Functional status
Timepoint [2] 341135 0
Baseline (admission), discharge, and 6–8 weeks post-discharge
Primary outcome [3] 341133 0
Vision-related quality of life
Timepoint [3] 341133 0
Baseline (admission), discharge, and 6–8 weeks post-discharge
Secondary outcome [1] 446419 0
Uptake of referrals and follow-up actions
Timepoint [1] 446419 0
Baseline (admission), discharge, and 6–8 weeks post-discharge
Secondary outcome [2] 446420 0
Visual function status
Timepoint [2] 446420 0
Baseline (admission), and 6–8 weeks post-discharge
Secondary outcome [3] 446421 0
Independent mobility status
Timepoint [3] 446421 0
Baseline (admission), discharge, and 6–8 weeks post-discharge
Secondary outcome [4] 446422 0
Brief Impact of Vision Impairment
Timepoint [4] 446422 0
Baseline (admission), discharge, and 6–8 weeks post-discharge

Eligibility
Key inclusion criteria
Adults admitted to inpatient rehabilitation at the University of Canberra Hospital.
Primary diagnosis of stroke (ischaemic or haemorrhagic) or orthopaedic fracture (e.g., hip, femur, pelvis, upper or lower limb).
Within the first week of rehabilitation admission.
Able to provide informed consent, or a substitute decision-maker can provide consent on their behalf.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cognitive impairment that precludes participation in assessments and no available proxy
Medically unstable or expected length of stay too short to allow completion of assessments
Non-English speakers (if materials/interpreters not available)
Unwilling or unable to provide informed consent (or no suitable substitute decision-maker)

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)
Central randomisation by an independent administrator using permuted block design, stratified by diagnosis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted in permuted blocks of four, and stratified for the two primary inclusion diagnoses Stroke and Fracture due to falls.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise participant demographics, clinical characteristics, and vision assessment outcomes. Between-group comparisons (intervention vs control) will be conducted using independent t-tests or Mann–Whitney U tests for continuous variables, and chi-square tests for categorical variables, depending on data distribution. Repeated measures (baseline, discharge, and 6–8 weeks post-discharge) will be analysed using linear mixed-effects models or repeated-measures ANOVA, adjusting for potential covariates. The primary analysis will follow an intention-to-treat principle. A significance level of p < 0.05 will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/06/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 27786 0
The University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research - Bruce
Recruitment postcode(s) [1] 43975 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 318742 0
Government body
Name [1] 318742 0
ACT Health Private Practice Fund
Country [1] 318742 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Country
Australia
Secondary sponsor category [1] 321180 0
Government body
Name [1] 321180 0
ACT Health
Address [1] 321180 0
Country [1] 321180 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317357 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 317357 0
Ethics committee country [1] 317357 0
Australia
Date submitted for ethics approval [1] 317357 0
14/02/2025
Approval date [1] 317357 0
22/05/2025
Ethics approval number [1] 317357 0
2025/ETH00338

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

Contacts
Principal investigator
Name 140786 0
A/Prof Mei Ying Boon
Address 140786 0
University of Canberra, 11 Kirinari Street, Bruce ACT 2617
Country 140786 0
Australia
Phone 140786 0
+61 421123133
Fax 140786 0
Email 140786 0
[email protected]
Contact person for public queries
Name 140787 0
Mei Ying Boon
Address 140787 0
University of Canberra, 11 Kirinari Street, Bruce ACT 2617
Country 140787 0
Australia
Phone 140787 0
+61 2 6201 5111
Fax 140787 0
Email 140787 0
[email protected]
Contact person for scientific queries
Name 140788 0
Mei Ying Boon
Address 140788 0
University of Canberra, 11 Kirinari Street, Bruce ACT 2617
Country 140788 0
Australia
Phone 140788 0
+61 2 6201 5111
Fax 140788 0
Email 140788 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.