The Investigators are running a small, early-phase research study across several hospitals in Melbourne, Australia. The study will involve up to 100 young adults between the ages of 18 and 55 who have had a stroke. The goal is to test how practical it is to carry out a detailed health assessment process-called "deep phenotyping"-with this group.
This process involves collecting a wide range of information and samples from stroke survivors to better understand each participant's condition. The Investigators will look at how well this approach works in practice, including how easy it is to use, whether it's done consistently, and how acceptable it is to participants.
At the same time, the Investigators will also explore how different factors-such as biological markers (biomarkers), age, sex, type of stroke, lifestyle, and environment-might be related to stroke recovery. This pilot study will prepare for larger studies in the future.
Between 18 and 55 years.
Within one month of acute stroke confirmed with standard of care brain imaging or clinical diagnosis or for those for whom recruitment <1 month of stroke is not possible they may be recruited to participate within 3-months of stroke
Severe, intercurrent or progressive illness likely to EITHER
Have a prognosis for survival under 24 months; OR
In the opinion of the investigator will mask the importance to the individual participant data (e.g. severe MS, dementia, etc)
Major psychiatric condition requiring medical intervention
Young adult stroke survivors within 3 months of stroke
Cohort
Prospective
Observational Cohort
Other interventionThe deep phenotyping observational study observes young adult stroke recovery trajectories and will also explore potential recovery biomarkers via: advanced MRI imaging; samples including blood, saliva, urine and hair stored for future analysis that may include (but is not limited to) proteomics, genomics and cortisol; and, a PET scan sub study involving \~20 participants (additional inclusion criteria) exploring the association of reactive astrogliosis with recovery outcomes using the experimental Positron Emission Tomography 18F-SMBT-1 tracer (AU TGA CTN in place). Associations with personal and environmental factors including: physical activity and sleep quality via device (Actigraph and Somfit) and self-report; exposures such as home and work environments, diet, socioeconomic status, and dental health; quality of life, resilience, and locus of control. Monitor healthcare utilisation, changes in medication and medical condition, participant experience and response to the assessments.
Implementability (feasibility, fidelity and acceptability)
Evaluation of the implementability will include assessment of the protocol's: * Feasibility, e.g. * Recruitment rate * Retention * Proportion of participants screened that enrolled * Safety via adverse events * Fidelity, e.g. * Proportion of assessments attended * Proportion of data collected and biobanked or analysed * Acceptability, e.g. o Participant acceptability surveys
Fatigue Severity Scale
FSS: A 9-item (or 7-item with the first two items removed) measure of fatigue impairment. Measured at baseline (\<1month post stroke), 3- and 6-months post stroke.
Visual Analogue Scale to Assess Fatigue (VAS-F)
18-item visual analogue scale of fatigue and energy items.
Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue
A multidimensional 21-item measure that evaluates physical, psychological and cognitive aspects of fatigue. Measured at baseline (\<1month post stroke), 3- and 6-months post stroke.
Cognitive Assessment
Assessment to evaluate cognitive domains such as visuospatial memory, auditory verbal learning, visual attention, task switching, verbal fluency, and verbal short-term and working memory. Assessment \<1-month, 3- and 6-months post stroke.
Click on the lead sponsor to view all of their trials.
The Florey Institute of Neuroscience and Mental Health
Lead sponsor
University of Melbourne
Collaborator
University of Newcastle, Australia
Collaborator
Austin Health
Collaborator
La Trobe University
Collaborator
The Alfred
Collaborator
