Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial
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,
on behalf of the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) investigators
Affiliations
Monique F. Kilkenny
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Muideen T. Olaiya
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Janette Cameron
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Natasha A. Lannin
Department of Neurosciences, Central Clinical School, Monash University
Nadine E. Andrew
Department of Medicine, Peninsula Clinical School, Central Clinical School, Monash University
Amanda G. Thrift
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Maree Hackett
The George Institute for Global Health, Faculty of Medicine, University of New South Wales
Ian Kneebone
Graduate School of Health, Faculty of Health, Graduate School of Health, University of Technology Sydney
Avril Drummond
Faculty of Medicine and Health Sciences, University of Nottingham
Vincent Thijs
Department of Medicine, Austin Health
Olivia Brancatisano
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Joosup Kim
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Megan Reyneke
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Shaun Hancock
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Liam Allan
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
Fiona Ellery
Stroke Division, Florey Institute of Neuroscience and Mental Health, University of Melbourne
Geoffrey Cloud
Department of Neuroscience, Central Clinical School, Monash University
Rohan S. Grimley
School of Medicine and Dentistry, Griffith University
Sandy Middleton
Nursing Research Institute, St Vincent’s Health Network Sydney and Australian Catholic University
Dominique A. Cadilhac
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University
on behalf of the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) investigators
Abstract 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
