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Barriers and Facilitators to Participation in Stroke Clinical Trials: A 6-Year Retrospective Analysis of Factors

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000227493
Enrollment
300
Registered
2025-03-28
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background and Rationale: Clinical trials are pivotal in advancing stroke care, yet participation remains low, exacerbating disparities, especially across age and gender demographics. This study aims to investigate the barriers to and facilitators of participation in clinical trials to enhance person-centred approaches in stroke research. Objectives: 1.To analyse the trends in age, gender, and rationales for non-participation in clinical trials among adult patients with stroke over the past 6 years at a tertiary Hospital in a large metropolitan area of Australia. 2.To develop and refine frameworks for patient recruitment that reduce barriers and enhance facilitation in stroke clinical trials. Study Design: A retrospective observational study complemented by a qualitative analysis of existing data from stroke patients who were eligible for clinical trial participation from January 2019 to January 2025.

Interventions

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

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

Sponsors

Primary Investigator - Pamela Galindo, The Alfred Hospital
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

None, apart from clinical trial-specific exclusions documented in patient records.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026