Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial
Authors: Kilkenny Monique F. , Olaiya Muideen T. , Cameron Janette , Lannin Natasha A. , Andrew Nadine E. , Thrift Amanda G. , Hackett Maree , Kneebone Ian , Drummond Avril , Thijs Vincent , Brancatisano Olivia , Kim Joosup , Reyneke Megan , Hancock Shaun , Allan Liam , Ellery Fiona , Cloud Geoffrey , Grimley Rohan S. , Middleton Sandy , Cadilhac Dominique A. ,   on behalf of the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) investigators, Cadilhac Dominique , Lannin Natasha , Dewey Helen , Kilkenny Monique , Andrew Nadine , Kneebone Ian , Drummond Avril , Cameron Jan , Thrift Amanda , Hackett Maree , Levi Christopher , Carey Mariko , Cloud Geoff , Grimley Rohan S. , Middleton Sandy , Thijs Vincent , Aslett Toni , Li Jonathon , Butler Ernest , Ma Henry , Galindo Pamela , Gocotano Mark , Moore Andrea , Camino Fides , Murphy Lily , Teodoro Michael , Coulton Bronwyn , Lee Louise , Choi Philip , Buchanan Claire , Busch Tessa , Ghia Darshan , Lee Phoebe , Edmonds Gillian , Singkang Rowena , Urbi Berzenn , Hall Nicola , Matanas Marie , Danton Rebecca , Bonanno Natasha , Tastula Kylie , Li Erin , Nolan Lucy , Kleinig Timothy , Cranefield Jennifer , Khanna Rajesh , Page Kirsty , Patel Disha , Jones Kelly , Dennien Sarah , Rowley Donna , McGufficke Suzanne , Grimley Rohan S. , Olaiya Muideen , Li Jonathan , Barnden Rebecca , Elston Amanda , Purvis Tara , Hankey Graeme , Churilov Leonid , Donnan Geoff , English Coralie , Cameron Jan , Brancatisano Olivia , Harris Dawn , Reyneke Megan , Coleman Lana , Thayabaranathan Tharshanah , Mosely Sue , Hancock Shaun , Afolabi Oluwatobi , Schadewaldt Verena , Withiel Toni , Ellery Fiona , Aslett Toni , Murphy Lisa , Horton Eleanor , Booth Brenda , Dempsey Ida 
Published: January 2024

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

Nil