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

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2024年1月23日

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

摘要

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