TY - JOUR
T1 - Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial
AU - Kilkenny, Monique F.
AU - Olaiya, Muideen T.
AU - Cameron, Janette
AU - Lannin, Natasha A.
AU - Andrew, Nadine E.
AU - Thrift, Amanda G.
AU - Hackett, Maree
AU - Kneebone, Ian
AU - Drummond, Avril
AU - Thijs, Vincent
AU - Brancatisano, Olivia
AU - Kim, Joosup
AU - Reyneke, Megan
AU - Hancock, Shaun
AU - Allan, Liam
AU - Ellery, Fiona
AU - Cloud, Geoffrey
AU - Grimley, Rohan S.
AU - Middleton, Sandy
AU - Cadilhac, Dominique A.
AU - on behalf of the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) Investigators
N1 - Funding Information:
The ReCAPS Phase III trial was funded by NHMRC (APP no. 1162596) from 2019 to 2023. The following authors received research fellowship support from the NHMRC (DAC: 1154273, MLH 1141328, MFK 1141848). NAL and MFK were supported by a Future Leader Fellowships (no. 106762 and no. 105737; respectively) from the National Heart Foundation of Australia.
Publisher Copyright:
© 2024, The Author(s).
PY - 2024/12
Y1 - 2024/12
N2 - 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.
AB - 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.
KW - Digital health
KW - eHealth
KW - Randomised controlled clinical trial
KW - Statistical analysis plan
KW - Stroke
UR - http://www.scopus.com/inward/record.url?scp=85182809061&partnerID=8YFLogxK
U2 - 10.1186/s13063-023-07864-2
DO - 10.1186/s13063-023-07864-2
M3 - Article
C2 - 38263172
AN - SCOPUS:85182809061
SN - 1745-6215
VL - 25
JO - Trials
JF - Trials
IS - 1
M1 - 78
ER -