Trial results for a study comparing different stroke care models were posted on ClinicalTrials.gov on 2026-05-15, involving 1,196 participants with stroke.
Background
Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health.
Trial design
This completed study, designated as Phase NA, enrolled 1,196 participants to investigate conditions including Stroke, Ischemic Stroke, Acute Stroke, Stroke Sequelae, and Patient Engagement. The study compared outcomes between an Integrated Stroke Practice Unit (ISPU) model and care provided at Comprehensive or Primary Stroke Centers (CSC/PSC).
Key results
The trial reported several key measurements comparing the Integrated Stroke Practice Unit (ISPU) and Comprehensive or Primary Stroke Center (CSC/PSC) groups:
- Stroke Impact Scale (SIS) at 12-months Post-discharge (Score):
- Integrated Stroke Practice Unit (ISPU): Mean 80.42 (Standard Deviation 21.28)
- Comprehensive or Primary Stroke Center (CSC/PSC): Mean 83.85 (Standard Deviation 18.31)
- Modified Rankin Scale at 12 Months Post-stroke (Participants):
- Integrated Stroke Practice Unit (ISPU): 214 participants, 134 participants
- Comprehensive or Primary Stroke Center (CSC/PSC): 255 participants, 107 participants
- Stroke Impact Scale (SIS) at 3-months Post-discharge (score on a scale):
- Integrated Stroke Practice Unit (ISPU): Mean 78.88 (Standard Deviation 21.07)
- Comprehensive or Primary Stroke Center (CSC/PSC): Mean 80.97 (Standard Deviation 20.78)
- Stroke Impact Scale (SIS) at 6-months Post-discharge (Score):
- Integrated Stroke Practice Unit (ISPU): Mean 80.15 (Standard Deviation 21.66)
- Comprehensive or Primary Stroke Center (CSC/PSC): Mean 81.39 (Standard Deviation 19.88)
- Modified Rankin Scale (mRS) at 3-months Post-discharge (Participants):
- Integrated Stroke Practice Unit (ISPU): 227 participants
- Comprehensive or Primary Stroke Center (CSC/PSC): 239 participants
What this means
The posted results provide comparative data on functional outcomes, as measured by the Stroke Impact Scale, and disability levels, as indicated by participant counts on the Modified Rankin Scale, for stroke patients managed under two different care models. While specific mean scores and participant counts are reported, the data does not include statistical analyses or significance levels. The mean SIS scores were slightly higher for the CSC/PSC group across all measured time points, suggesting potentially better patient-reported outcomes, though the clinical significance of these differences cannot be determined from the provided data. These findings contribute to understanding the performance of different stroke care delivery systems.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04000971, titled "Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care", were posted on 2026-05-15 on clinicaltrials.gov.