Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial

Background: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. Methods/design: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. Conclusions: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. Trial registration: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Ni

Univariable analysis of knowledge of risk factors for CVD by CVD risk status.

<p>Univariable analysis of knowledge of risk factors for CVD by CVD risk status.</p

Characteristics of participants by CVD risk status.

<p>Characteristics of participants by CVD risk status.</p

Multivariable analysis of factors associated with knowledge of risk factors for diabetes/CVD.

<p>Multivariable analysis of factors associated with knowledge of risk factors for diabetes/CVD.</p

Multivariable analysis of factors associated with greater knowledge of complications of diabetes.

<p>Multivariable analysis of factors associated with greater knowledge of complications of diabetes.</p

Univariable analysis of knowledge of complications of diabetes by diabetes risk status.

<p>Univariable analysis of knowledge of complications of diabetes by diabetes risk status.</p

Example of self-reported medical history and knowledge questions from the Participant Questionnaire collected at the time of the Know your numbers health check.

<p>Example of self-reported medical history and knowledge questions from the Participant Questionnaire collected at the time of the Know your numbers health check.</p

sj-docx-2-cre-10.1177_02692155241232990 - Supplemental material for Access to inpatient mood management services after stroke in Australian acute and rehabilitation hospitals

Supplemental material, sj-docx-2-cre-10.1177_02692155241232990 for Access to inpatient mood management services after stroke in Australian acute and rehabilitation hospitals by Shaun L Hancock, Tara Purvis, Tharshanah Thayabaranathan, Rene Stolwyk, Jan Cameron, Lachlan L Dalli, Megan Reyneke, Monique F Kilkenny, Kelvin Hill and Dominique A Cadilhac in Clinical Rehabilitation</p

sj-docx-1-cre-10.1177_02692155241232990 - Supplemental material for Access to inpatient mood management services after stroke in Australian acute and rehabilitation hospitals

Supplemental material, sj-docx-1-cre-10.1177_02692155241232990 for Access to inpatient mood management services after stroke in Australian acute and rehabilitation hospitals by Shaun L Hancock, Tara Purvis, Tharshanah Thayabaranathan, Rene Stolwyk, Jan Cameron, Lachlan L Dalli, Megan Reyneke, Monique F Kilkenny, Kelvin Hill and Dominique A Cadilhac in Clinical Rehabilitation</p

Additional file 1 of Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial

Additional file1: Supplemental tables: Supplemental Table I. Intervention fidelity. Supplemental Table II. Characteristics of participants at baseline. Supplemental Table III. Adverse events and serious adverse events related to the interventio