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

Kilkenny, MF; Olaiya, MT; Cameron, J; Lannin, NA; Andrew, NE; Thrift, AG; Hackett, M; Kneebone, I; Drummond, A; Thijs, V; Brancatisano, O; Kim, J; Reyneke, M; Hancock, S; Allan, L; Ellery, F; Cloud, G; Grimley, RS; Middleton, S; Cadilhac, DA; Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) investigators,

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

Kilkenny, MF Olaiya, MT Cameron, J Lannin, NA Andrew, NE Thrift, AG Hackett, M Kneebone, I

Drummond, A Thijs, V Brancatisano, O Kim, J Reyneke, M Hancock, S Allan, L Ellery, F Cloud, G Grimley, RS Middleton, S Cadilhac, DA Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) investigators,

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Publisher:: Springer Nature
Publication Type:: Journal Article
Citation:: Trials, 2024, 25, (1), pp. 78
Issue Date:: 2024-01-23

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Field	Value	Language
dc.contributor.author	Kilkenny, MF
dc.contributor.author	Olaiya, MT
dc.contributor.author	Cameron, J
dc.contributor.author	Lannin, NA
dc.contributor.author	Andrew, NE
dc.contributor.author	Thrift, AG
dc.contributor.author	Hackett, M
dc.contributor.author	Kneebone, I https://orcid.org/0000-0003-3324-7264
dc.contributor.author	Drummond, A
dc.contributor.author	Thijs, V
dc.contributor.author	Brancatisano, O
dc.contributor.author	Kim, J
dc.contributor.author	Reyneke, M
dc.contributor.author	Hancock, S
dc.contributor.author	Allan, L
dc.contributor.author	Ellery, F
dc.contributor.author	Cloud, G
dc.contributor.author	Grimley, RS
dc.contributor.author	Middleton, S
dc.contributor.author	Cadilhac, DA
dc.contributor.author	Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) investigators,
dc.date.accessioned	2024-08-01T03:29:17Z
dc.date.available	2023-11-30
dc.date.available	2024-08-01T03:29:17Z
dc.date.issued	2024-01-23
dc.identifier.citation	Trials, 2024, 25, (1), pp. 78
dc.identifier.issn	1745-6215
dc.identifier.issn	1745-6215
dc.identifier.uri	http://hdl.handle.net/10453/179899
dc.description.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.
dc.format	Electronic
dc.language	eng
dc.publisher	Springer Nature
dc.relation.ispartof	Trials
dc.relation.isbasedon	10.1186/s13063-023-07864-2
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
dc.subject.classification	Cardiovascular System & Hematology
dc.subject.classification	General & Internal Medicine
dc.subject.classification	3202 Clinical sciences
dc.subject.classification	4202 Epidemiology
dc.subject.classification	4203 Health services and systems
dc.subject.mesh	Humans
dc.subject.mesh	Community Support
dc.subject.mesh	Patient Readmission
dc.subject.mesh	Digital Health
dc.subject.mesh	Educational Status
dc.subject.mesh	Electronics
dc.subject.mesh	Stroke
dc.subject.mesh	Humans
dc.subject.mesh	Patient Readmission
dc.subject.mesh	Electronics
dc.subject.mesh	Educational Status
dc.subject.mesh	Stroke
dc.subject.mesh	Community Support
dc.subject.mesh	Digital Health
dc.subject.mesh	Humans
dc.subject.mesh	Community Support
dc.subject.mesh	Patient Readmission
dc.subject.mesh	Digital Health
dc.subject.mesh	Educational Status
dc.subject.mesh	Electronics
dc.subject.mesh	Stroke
dc.title	Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial.
dc.type	Journal Article
utslib.citation.volume	25
utslib.location.activity	England
utslib.for	1102 Cardiorespiratory Medicine and Haematology
utslib.for	1103 Clinical Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/Faculty of Health/Graduate School of Health
pubs.organisational-group	University of Technology Sydney/Faculty of Health/Graduate School of Health/GSH.Clinical Psychology
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/
dc.date.updated	2024-08-01T03:29:13Z
pubs.issue	1
pubs.publication-status	Published online
pubs.volume	25
utslib.citation.issue	1

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.

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