Prospective Global Platform to Evaluate and Enhance Cognitive and Functional Trajectories after Stroke (PROSPECT)


a) Background: The determinants of functional and cognitive outcomes after stroke are incompletely understood. This platform will prospectively evaluate outcomes after stroke, with integration of interventions and randomized controlled trials (RCTs) to improve functional and cognitive outcomes after stroke.

b) Aim/objective:

1. Describe global and regional variation and determinants in the burden and trajectory of cognitive and functional impairment in the acute and chronic phase after ischemic and hemorrhagic stroke.

2. Determine attributable risk for cognitive and functional impairment in stroke for stroke-specific factors, processes of care, socioeconomic factors, lifestyles, co-morbidities, biomarkers, and household and community-level characteristics.

3. Create a platform to reduce the barriers and resources required for large, broad, generalizable RCTs that address simple and widely applicable strategies to improve stroke-stroke cognitive and functional impairment and allow patients to live longer and better.

c) Methods: There are four main pillars to PROSPECT:  I) Cohort study; II) RCTs; III) Discovery and IV) Knowledge translation (KT).  The cohort study will serve as the foundation of PROSPECT, with ongoing, web-based, large volume and reliable data collection from all participating sites.  The RCTs will be embedded within ongoing data collection, with the major advantage of easily recruiting large numbers of eligible and well characterized patients, who have already enrolled in a long-term program.  The discovery pillar will try to identify the biomarkers (genetics, proteomics and metabolomics) that impact recovery in function and cognition after a stroke and could be potential targets to modify the disease course.  Finally, evidence from the RCTs will be able to be rapidly translated to practice using patients, policy partners, and clinician networks involved in the program.

The cohort study will start with a vanguard phase (Pilot Phase) at select sites.  The objective of the vanguard phase of PROSPECT is to demonstrate feasibility of recruitment and retention of participants, to test and improve case report forms with quality checks and audits, and evaluate suitability and initial distribution of outcomes, which will support the expansion of PROSPECT to a wider number of sites.  This phase will be followed by finalization of the protocol and case report forms based on feedback and initiation of other sites within Canada and internationally. 

d) Sample size: 20,000?25,000 patients enrolled over 5 years from stroke centres in North America, South America, Europe, Africa, Asia and the Middle East. Recruitment goal for India is 4000-5000 participants.

The recruitment goal for the vanguard phase in India is 100–200 participants.

e) Updated as on: 16th Dec 2023

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