Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/35009
Title: Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial.
Austin 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 N ;Brancatisano, Olivia;Kim, Joosup;Reyneke, Megan;Hancock, Shaun;Allan, Liam;Ellery, Fiona;Cloud, Geoffrey;Grimley, Rohan S;Middleton, Sandy;Cadilhac, Dominique A
Affiliation: The Florey Institute of Neuroscience and Mental Health
Department of Neurosciences, Central Clinical School, Monash University, Melbourne, Australia.;Alfred Health, Melbourne, Australia.
Department of Medicine, Peninsula Clinical School, Central Clinical School, Monash University, Clayton, Australia.;National Centre for Healthy Ageing, Monash University, Frankston, Australia.
Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia.
The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
Graduate School of Health, Faculty of Health, Graduate School of Health, University of Technology Sydney, Ultimo, Australia.
Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
General Medicine
Department of Neuroscience, Central Clinical School, Monash University, Clayton, Australia.;Stroke Services, Alfred Health, Melbourne, Australia.
School of Medicine and Dentistry, Griffith University, Birtinya, Australia.
Nursing Research Institute, St Vincent's Health Network Sydney and Australian Catholic University, Sydney, Australia.
Issue Date: 23-Jan-2024
Date: 2024
Publication information: Trials 2024-01-23; 25(1)
Abstract: 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. 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. 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. 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.
URI: https://ahro.austin.org.au/austinjspui/handle/1/35009
DOI: 10.1186/s13063-023-07864-2
ORCID: 0000-0002-3375-287X
0000-0002-4070-0533
0000-0002-3335-904X
0000-0002-2066-8345
0000-0002-4846-2840
0000-0001-8533-4170
0000-0003-1211-9087
0000-0003-3324-7264
0000-0003-1220-8354
0000-0002-6614-8417
0000-0001-9139-3046
0000-0002-4079-0428
0000-0003-2902-4666
0000-0002-2015-2752
0000-0001-9291-080X
0000-0002-8365-6907
0000-0002-7006-6908
0000-0002-7201-4394
0000-0001-8162-682X
Journal: Trials
Start page: 78
PubMed URL: 38263172
ISSN: 1745-6215
Type: Journal Article
Subjects: Digital health
Randomised controlled clinical trial
Statistical analysis plan
Stroke
eHealth
Appears in Collections:Journal articles

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