Background

The system-integrated technology-enabled model of care (SINEMA) trial aimed to evaluate the effectiveness of a community-based multi-component intervention for secondary prevention of stroke in rural China.

Objective

To present the detailed statistical analysis plan for the trial prior to database locking and data analysis.

Methods

The detailed analysis plan outlines primary and secondary outcome measures, describes the over-arching data analysis principles to be adopted as well as more detailed descriptions of specific analytical approaches for effectiveness analyses, as well strategies to handle missing outcome data.

Discussion

Publication of the statistical analysis plan increases the transparency of the data analysis procedure and reduces potential bias in trial reporting.

Trial registration

The trial was registered with clinicaltrials.gov (NCT03185858).