Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)

Dominique Cadilhac; Jan Cameron; Monique F Kilkenny; Nadine Elizabeth Andrew; Dawn Harris; Fiona Ellery; Amanda G Thrift; Tara Purvis; Ian Kneebone; Helen Dewey; Avril Drummond; Maree L Hackett; Rohan Grimley; Sandy Middleton; Vincent Thijs; Geoffrey Cloud; Mariko L Carey; Ernest Butler; Henry Ma; Leonid Churilov; Graeme J Hankey; Coralie Kym English; Natasha A Lannin

doi:10.1177/17474930211022678

Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)

Dominique Cadilhac, Jan Cameron, Monique F Kilkenny, Nadine Elizabeth Andrew, Dawn Harris, Fiona Ellery, Amanda G Thrift, Tara Purvis, Ian Kneebone, Helen Dewey, Avril Drummond, Maree L Hackett, Rohan Grimley, Sandy Middleton, Vincent Thijs, Geoffrey Cloud, Mariko L Carey, Ernest Butler, Henry Ma, Leonid ChurilovGraeme J Hankey, Coralie Kym English, Natasha A Lannin

Internal Medicine

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

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Abstract

RATIONALE: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited.

HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation.

METHODS AND DESIGN: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation.

PARTICIPANTS: Confirmed stroke (modified Rankin Score: 0-4), aged â¥18 years with internet/mobile phone access, discharged directly home from hospital. Randomisation: 1:1 computer-generated, stratified by age and baseline disability.Outcomes Assessments: Collected at 90 days and 12 months following randomisation.

OUTCOMES: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months.

SAMPLE SIZE: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of Î±=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100.

DISCUSSION: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.

Original language	English
Pages (from-to)	236-241
Number of pages	6
Journal	International Journal of Stroke
Volume	17
Issue number	2
Early online date	26 May 2021
DOIs	https://doi.org/10.1177/17474930211022678
Publication status	Published - Feb 2022

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Cadilhac, et al., 2021 EXPRESSAccepted author manuscript, 244 KB

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Cadilhac, D., Cameron, J., Kilkenny, M. F., Andrew, N. E., Harris, D., Ellery, F., Thrift, A. G., Purvis, T., Kneebone, I., Dewey, H., Drummond, A., Hackett, M. L., Grimley, R., Middleton, S., Thijs, V., Cloud, G., Carey, M. L., Butler, E., Ma, H., ... Lannin, N. A. (2022). Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS). International Journal of Stroke, 17(2), 236-241. https://doi.org/10.1177/17474930211022678

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title = "Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)",

abstract = "RATIONALE: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited.HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation.METHODS AND DESIGN: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation.PARTICIPANTS: Confirmed stroke (modified Rankin Score: 0-4), aged {\^a}¥18 years with internet/mobile phone access, discharged directly home from hospital. Randomisation: 1:1 computer-generated, stratified by age and baseline disability.Outcomes Assessments: Collected at 90 days and 12 months following randomisation.OUTCOMES: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months.SAMPLE SIZE: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of {\^I}±=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100.DISCUSSION: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.",

author = "Dominique Cadilhac and Jan Cameron and Kilkenny, {Monique F} and Andrew, {Nadine Elizabeth} and Dawn Harris and Fiona Ellery and Thrift, {Amanda G} and Tara Purvis and Ian Kneebone and Helen Dewey and Avril Drummond and Hackett, {Maree L} and Rohan Grimley and Sandy Middleton and Vincent Thijs and Geoffrey Cloud and Carey, {Mariko L} and Ernest Butler and Henry Ma and Leonid Churilov and Hankey, {Graeme J} and English, {Coralie Kym} and Lannin, {Natasha A}",

year = "2022",

month = feb,

doi = "10.1177/17474930211022678",

language = "English",

volume = "17",

pages = "236--241",

journal = "International Journal of Stroke",

issn = "1747-4930",

publisher = "Wiley-Blackwell",

number = "2",

}

Cadilhac, D, Cameron, J, Kilkenny, MF, Andrew, NE, Harris, D, Ellery, F, Thrift, AG, Purvis, T, Kneebone, I, Dewey, H, Drummond, A, Hackett, ML, Grimley, R, Middleton, S, Thijs, V, Cloud, G, Carey, ML, Butler, E, Ma, H, Churilov, L, Hankey, GJ, English, CK & Lannin, NA 2022, 'Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)', International Journal of Stroke, vol. 17, no. 2, pp. 236-241. https://doi.org/10.1177/17474930211022678

Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS). / Cadilhac, Dominique; Cameron, Jan; Kilkenny, Monique F et al.

In: International Journal of Stroke, Vol. 17, No. 2, 02.2022, p. 236-241.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)

AU - Cadilhac, Dominique

AU - Cameron, Jan

AU - Kilkenny, Monique F

AU - Andrew, Nadine Elizabeth

AU - Harris, Dawn

AU - Ellery, Fiona

AU - Thrift, Amanda G

AU - Purvis, Tara

AU - Kneebone, Ian

AU - Dewey, Helen

AU - Drummond, Avril

AU - Hackett, Maree L

AU - Grimley, Rohan

AU - Middleton, Sandy

AU - Thijs, Vincent

AU - Cloud, Geoffrey

AU - Carey, Mariko L

AU - Butler, Ernest

AU - Ma, Henry

AU - Churilov, Leonid

AU - Hankey, Graeme J

AU - English, Coralie Kym

AU - Lannin, Natasha A

PY - 2022/2

Y1 - 2022/2

N2 - RATIONALE: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited.HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation.METHODS AND DESIGN: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation.PARTICIPANTS: Confirmed stroke (modified Rankin Score: 0-4), aged â¥18 years with internet/mobile phone access, discharged directly home from hospital. Randomisation: 1:1 computer-generated, stratified by age and baseline disability.Outcomes Assessments: Collected at 90 days and 12 months following randomisation.OUTCOMES: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months.SAMPLE SIZE: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of Î±=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100.DISCUSSION: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.

AB - RATIONALE: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited.HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation.METHODS AND DESIGN: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation.PARTICIPANTS: Confirmed stroke (modified Rankin Score: 0-4), aged â¥18 years with internet/mobile phone access, discharged directly home from hospital. Randomisation: 1:1 computer-generated, stratified by age and baseline disability.Outcomes Assessments: Collected at 90 days and 12 months following randomisation.OUTCOMES: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months.SAMPLE SIZE: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of Î±=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100.DISCUSSION: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.

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U2 - 10.1177/17474930211022678

DO - 10.1177/17474930211022678

M3 - Article

C2 - 34037468

VL - 17

SP - 236

EP - 241

JO - International Journal of Stroke

JF - International Journal of Stroke

SN - 1747-4930

IS - 2

ER -

Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)

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