Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation...

Area of Science:

• Neurology
• Digital Health
• Health Services Research

Background:

• Unplanned hospital presentations post-stroke often stem from inadequate transition support from hospital to home.
• The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial addresses this gap.
• A 12-week self-management intervention, including personalized goal setting and digital messaging, was developed.

Purpose of the Study:

• To present the statistical analysis plan for the ReCAPS trial.
• To outline the methodology for evaluating the effectiveness of a digital health support package in reducing unplanned hospital presentations post-stroke.

Main Methods:

• 1:1 randomization with stratification by age and baseline disability.
• Sample size of 890 participants calculated for a 10% absolute reduction in unplanned hospital presentations.
• Logistic regression adjusted for stratification variables will analyze the primary outcome (unplanned hospital presentations within 90 days).
• Intention-to-treat analysis will be employed for the primary outcome.

Main Results:

• Primary outcome: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation.
• Secondary outcomes will be evaluated using appropriate regression models.
• Statistical significance will be determined by a p-value ≤ 0.05.

Conclusions:

• The statistical analysis plan ensures transparent reporting of ReCAPS trial outcomes.
• The ReCAPS trial is expected to provide novel evidence on the effectiveness of digital health interventions for post-stroke care.