Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000227493p
Ethics application status
Not yet submitted
Date submitted
27/01/2025
Date registered
28/03/2025
Date last updated
28/03/2025
Date data sharing statement initially provided
28/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Barriers and Facilitators to Participation in Stroke Clinical Trials: A 6-Year Retrospective Analysis of Factors
Scientific title
A Retrospective Observational Study Investigating Barriers and Facilitators to Participation in Stroke Clinical Trials Among Adult Patients Over a 6-Year Period in a Metropolitan Tertiary Hospital in Australia
Secondary ID [1] 313819 0
na
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 336456 0
Condition category
Condition code
Stroke 332976 332976 0 0
Ischaemic
Stroke 332977 332977 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational - Retrospective analysis of existing patient data focusing on factors affecting clinical trial participation.

1) This study is collecting data retrospectively from medical records,
2) what is being observed in participants,
- Basic demographics including age, race, and gender at birth
- Diagnosis including onset of stroke and severity
- Previous health history, commorbidites
- social history
-Baseline Glasgow Coma Scale (GCS), and National Institutes of Health Stroke Scale (NIHSS); GCS and NIHSS upon presentation to the hospital; and GCS and NIHSS upon approaching the patient for participation of clinical trial.
- Discharge destinations
- Retrospective data of suitability for Stroke Clinical Trials at a tertiary hospital in Melbourne CBD
- Reasons why patients who are eligible for clinical trials have refused for the enrolment of the study
3) No questionnaire will be involved as this is a retrospective observational study.
A lldata needed are already collected,
4) The source and time period (minimum month and year) this retrospective data was collected, - January 2019 - January 2025
Intervention code [1] 330407 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340513 0
Determining reasons why patients chose not to participate in a stroke trial
Timepoint [1] 340513 0
Retrospective review (January 2019 – January 2025) within one week of diagnosed with stroke of each of the patients.
Primary outcome [2] 340727 0
Number and proportion of patients who did not participate in clinical trials, stratified by gender and age group.
Timepoint [2] 340727 0
January 2019 – January 2025) within one week of diagnosed with stroke of each of the patients,
Secondary outcome [1] 444314 0
Number and proportion of patients reporting each category of non-participation reasons (e.g., willingness, feasibility), documented through patient records and research staff notes.
Timepoint [1] 444314 0
At the time of initial eligibility screening for each patient, as documented in the tertiary hospital in Melbourne CBD Stroke Screen log. Data will be analyzed retrospectively at the end of the study period (January 2025), with assessments conducted for each year from January 2019 to January 2025 to identify trends over time.

Eligibility
Key inclusion criteria
a) Adults aged 18 years or older.
b) Diagnosed with stroke and considered for participation in clinical trials from January 2019 to January 2025.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None, apart from clinical trial-specific exclusions documented in patient records.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis
Quantitative analysis will involve trend analysis over time and chi-squared tests to determine the association between demographic factors and non-participation reasons. A p-value of less than 0.05 will be considered statistically significant. Qualitative analysis will involve thematic analysis of patient narratives to extract meaningful patterns and themes regarding reasons for non-participation.

Quantitative analysis will involve trend analysis over time and chi-squared tests to determine the association between demographic factors and non-participation reasons. A p-value of less than 0.05 will be considered statistically significant. Qualitative analysis will involve thematic analysis of patient narratives to extract meaningful patterns and themes regarding reasons for non-participation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318288 0
Self funded/Unfunded
Name [1] 318288 0
Self funded by Primary Investigator (Pamela Galindo) and seeking support from research grants and institutional funds.
Country [1] 318288 0
Australia
Primary sponsor type
Individual
Name
Primary Investigator - Pamela Galindo, The Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 320672 0
None
Name [1] 320672 0
Address [1] 320672 0
Country [1] 320672 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316929 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316929 0
Ethics committee country [1] 316929 0
Australia
Date submitted for ethics approval [1] 316929 0
07/04/2025
Approval date [1] 316929 0
Ethics approval number [1] 316929 0

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

Contacts
Principal investigator
Name 139454 0
Mrs Pamela Galindo
Address 139454 0
The Alfred Hospital - 99 Commercial Road, Melbourne, VIC, 3004
Country 139454 0
Australia
Phone 139454 0
+61 452248008
Fax 139454 0
Email 139454 0
[email protected]
Contact person for public queries
Name 139455 0
Pamela Galindo
Address 139455 0
99 Commercial Road, Melbourne, VIC, 3004
Country 139455 0
Australia
Phone 139455 0
+61 452248008
Fax 139455 0
Email 139455 0
[email protected]
Contact person for scientific queries
Name 139456 0
Pamela Galindo
Address 139456 0
The Alfred Hospital - 99 Commercial Road, Melbourne, VIC, 3004
Country 139456 0
Australia
Phone 139456 0
+61 452248008
Fax 139456 0
Email 139456 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.