SaFaRI
Trial question
What is the role of primary care-based, system-integrated, technology-enabled model of care in patients with stroke?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 998
998 patients (454 female, 544 male).
Inclusion criteria: community-dwelling clinically stable surviving patients with stroke.
Key exclusion criteria: bedridden; severe life-threatening diseases with an expected life span < 6 months; serious mental illness.
Interventions
N=499 system-integrated, technology-enabled model of care (primary care-based digital health-enabled stroke management).
N=499 usual care (receipt of usual care necessitating proactive care seeking).
Primary outcome
Reduction in long-term systolic blood pressure
4.4 mmHg
2.2 mmHg
4.4 mmHg
3.3 mmHg
2.2 mmHg
1.1 mmHg
0.0 mmHg
System-integrated, technology-enabled model of
care
Usual
care
Significant
increase ▲
Significantly greater reduction in long-term SBP (4.4 mmHg vs. 2.2 mmHg; MD 2.8, 95% CI 0.3 to 5.3).
Secondary outcomes
Significant decrease in long-term stroke recurrence (20.2% vs. 25.7%; RR 0.77, 95% CI 0.61 to 0.99).
No significant difference in long-term moderate-to-severe disability (33.1% vs. 33.1%; RR 0.93, 95% CI 0.78 to 1.1).
Significant increase in long-term adherence to antihypertensive medication regimen (66.8% vs. 60.7%; RR 1.11, 95% CI 1 to 1.23).
Conclusion
In community-dwelling clinically stable surviving patients with stroke, system-integrated, technology-enabled model of care was superior to usual care with respect to reduction in long-term SBP.
Reference
Jie Tan, Enying Gong, John A Gallis et al. Primary Care-Based Digital Health-Enabled Stroke Management Intervention: Long-Term Follow-Up of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2449561.
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