Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000447459
Ethics application status
Approved
Date submitted
10/04/2025
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comprehensive evaluation of telehealth outpatient stroke service in rural and remote Australia: A multicentre study protocol
Scientific title
Comprehensive evaluation of telehealth outpatient stroke service in rural and remote Australia: A multicentre study protocol
Secondary ID [1] 314136 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 336950 0
Condition category
Condition code
Stroke 333420 333420 0 0
Ischaemic
Stroke 333421 333421 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
We will be collecting data of consecutive patients reviewed at the Manning Base Hospital, Tamworth, Moree & Armidale Telestroke clinics run by the John Hunter Stroke Team.
This study is a cohort study of the patients reviewed through these clinics. This study was reviewed by our ethics committee and considered low risk. Consent for inclusion is not required. Thus, this is not an interventional study, and every patient assessed through the clinic would be included into the study.
Patients will be reviewed through the telestroke clinics closer to their home address. The interventions made in the clinic are related to standard of care stroke management:
-We plan to observe the percentage of interventions required, including : changes in diagnosis, medication, complementary tests, referral to other specialists or referrals to clinical trials.
- We have collected as well the recurrence of ischaemic events at 12 months (cerebrovascular and cardiovascular). This is done looking at the electronic medical records available in our local health district.
-The only questionnaire for this study is a survey about the care provided. This is anonymous and not a mandatory requirement for patients attending the clinics. The survery contains a total of 21 questions, focused on the patient experience. The survey questions were created by a multidisciplinary team, including neurologists, allied health specialists and consumers.
Telestroke clinic patients will be asked to complete the questionnaire following their initial clinic appointment.
The following options for completion will be offered to those patients who wish to complete the questionnaire:
1. Immediately after the appointment either electronically or in paper form (the clinic coordinator will leave the room to avoid coercian).
2. At the patients home after the appointment. A link will be sent to the patients by email & text.
Intervention code [1] 330781 0
Diagnosis / Prognosis
Comparator / control treatment
The standard care cohort (control cohort) was formed by merging two different available databases: The Stroke Reperfusion Database and the Unit Record Data Database from the Hunter New England Local Health District. The Stroke Reperfusion Database was developed by the CSC stroke team, formed by acute stroke call patients received from any of the four PSCs since April 2013. Data from this database used in this study came from patients assessed from January 2018 until the end of the regional reperfusion therapy model in 2020.
The Unit Record Data Database includes information of every patient admitted at any of the four PSCs with an International Statistical Classification of Diseases and Related Health Problems (ICD) 10 coding of G45 (transient cerebral ischemic attack), I62 (intracerebral haemorrhage), I63 (cerebral infarction) or I64 (stroke, not specified as haemorrhage or infarction) from January 2018 to June 2023.
Every individual record from this database which formed the control cohort was assessed as eligible by two stroke neurologists who reviewed each individual’s clinical presentation and brain imaging performed during and after their admission.
Control group
Historical

Outcomes
Primary outcome [1] 341066 0
Rate of cerebrovascular events at 12 months in patients assessed through the telestroke clinic compared to those patients managed through standard pathways.
Timepoint [1] 341066 0
The outcome will be measured at 12 months from stroke onset.
Secondary outcome [1] 446023 0
Healthcare costs associated with post-stroke care.
Timepoint [1] 446023 0
The outcome will be measured at 12 months from stroke onset.
Secondary outcome [2] 446506 0
Patient experience.
Timepoint [2] 446506 0
The outcome will be measured following the telestroke clinic consultation.
Secondary outcome [3] 446507 0
Recurrent vascular events.
Timepoint [3] 446507 0
The outcome will be measured at 12 months from stroke onset.

Eligibility
Key inclusion criteria
The audit will include consecutive patients reviewed in the telestroke clinics at the following hospitals by the John Hunter Hospital stroke team:
Manning Base Hospital
Tamworth Hospital
Armidale Hospital
Moree Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics are reported as the mean with standard deviation (SD) or median with interquartile range (IQR) for continuous variables and as frequency and percentage for categorical variables. The baseline characteristics of each study arm are summarised and compared using appropriate statistical methods, including parametric or non-parametric tests for continuous variables and chi-square tests for categorical variables, based on the data distribution. Logistic regression models estimate the odds ratios (OR) for the primary and secondary outcomes, while Cox proportional hazards models estimate the hazard ratios (HR). All logistic and Cox proportional models are adjusted for covariates that are statistically and clinically significant. All primary and secondary analysis models present relevant parameter estimates, 95% confidence intervals, and p-values for reporting purposes. All the analysis are performed in using Stata 18 software (Stata Statistical Software: Relvase 18. College Statin, TX: StataCorp LLC).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318645 0
Hospital
Name [1] 318645 0
John Hunter Hospital
Country [1] 318645 0
Australia
Funding source category [2] 318699 0
Government body
Name [2] 318699 0
Improvement Grant Program, Hunter New England Local Health District
Country [2] 318699 0
Australia
Funding source category [3] 318700 0
Commercial sector/Industry
Name [3] 318700 0
Avant Foundation
Country [3] 318700 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321110 0
None
Name [1] 321110 0
Address [1] 321110 0
Country [1] 321110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317256 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 317256 0
Ethics committee country [1] 317256 0
Australia
Date submitted for ethics approval [1] 317256 0
31/03/2021
Approval date [1] 317256 0
21/06/2021
Ethics approval number [1] 317256 0
2021/ETH00452

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

Contacts
Principal investigator
Name 140482 0
A/Prof Carlos Garcia Esperon
Address 140482 0
Neurology Department, Level 2, John Hunter Hospitial, Locked Bag No.1 HRMC, 2310, NSW
Country 140482 0
Australia
Phone 140482 0
+61 2 49 213490
Fax 140482 0
Email 140482 0
[email protected]
Contact person for public queries
Name 140483 0
Carlos Garcia Esperon
Address 140483 0
Neurology Department, Level 2, John Hunter Hospitial, Locked Bag No.1 HRMC, 2310, NSW
Country 140483 0
Australia
Phone 140483 0
+61 2 49 213490
Fax 140483 0
Email 140483 0
[email protected]
Contact person for scientific queries
Name 140484 0
Carlos Garcia Esperon
Address 140484 0
Neurology Department, Level 2, John Hunter Hospitial, Locked Bag No.1 HRMC, 2310, NSW
Country 140484 0
Australia
Phone 140484 0
+61 2 49 213490
Fax 140484 0
Email 140484 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.