Protocol of a randomized controlled trial investigating the effectiveness of recovery-focused community support to avoid readmissions and improve participation after stroke (ReCAPS)

Journal article


Cadilhac, Dominique A., Cameron, Jan, Kilkenny, Monique F., Andrew, Nadine E., Harris, Dawn, Ellery, Fiona, Thrift, Amanda G., Purvis, Tara, Kneebone, Ian, Dewey, Helen, Drummond, Avril, Hackett, Maree, Grimley, Rohan, Middleton, Sandy, Thijs, Vincent, Cloud, Geoffrey, Carey, Mariko, Butler, Ernest, Ma, Henry, ... Lannin, Natasha A.. (2021). Protocol of a randomized controlled trial investigating the effectiveness of recovery-focused community support to avoid readmissions and improve participation after stroke (ReCAPS). International Journal of Stroke. https://doi.org/10.1177/17474930211022678
AuthorsCadilhac, Dominique A., Cameron, Jan, Kilkenny, Monique F., Andrew, Nadine E., Harris, Dawn, Ellery, Fiona, Thrift, Amanda G., Purvis, Tara, Kneebone, Ian, Dewey, Helen, Drummond, Avril, Hackett, Maree, Grimley, Rohan, Middleton, Sandy, Thijs, Vincent, Cloud, Geoffrey, Carey, Mariko, Butler, Ernest, Ma, Henry, Churilov, Leonid, Hankey, Graeme J., English, Coralie and Lannin, Natasha A.
Abstract

Rationale
To address unmet needs, electronic messages to support person-centered 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 randomization.

Methods and design
Multicenter, double-blind, randomized controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalized, goal-centered, and administrative electronic messages, while the control group only receive 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 ≥18 years with internet/mobile phone access, discharged directly home from hospital. Randomization: 1:1 computer-generated, stratified by age and baseline disability. Outcomes assessments: Collected at 90 days and 12 months following randomization.

Outcomes
Primary outcomes include hospital emergency presentations/admissions within 90 days of randomization. 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 α = 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.

Keywordsstroke; eHealth; self-management; healthcare technology; clinical trial protocol
Year2021
JournalInternational Journal of Stroke
PublisherSAGE Publications Inc.
ISSN1747-4930
Digital Object Identifier (DOI)https://doi.org/10.1177/17474930211022678
Scopus EID2-s2.0-85108011017
Research or scholarlyResearch
Page range1-6
FunderNational Health and Medical Research Council
Publisher's version
License
All rights reserved
File Access Level
Controlled
Output statusPublished
Publication dates
Online14 Jun 2021
Publication process dates
Accepted14 May 2021
Deposited21 Oct 2021
Grant IDNHMRC/1162596
NHMRC/1154273
NHMRC/1141328
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Better outcomes for hospitalized patients with TIA when in stroke units: An observational study
Cadilhac, Dominique A., Kim, Joosup, Lannin, Natasha A., Levi, Christopher R., Dewey, Helen M., Hill, Kelvin, Faux, Steven, Andrew, Nadine E., Kilkenny, Monique F., Grimley, Rohan, Thrift, Amanda G., Grabsch, Brenda, Middleton, Sandy, Anderson, Craig S. and Donnan, Geoffrey A.. (2016). Better outcomes for hospitalized patients with TIA when in stroke units: An observational study. Neurology. 86(22), pp. 2042-2048. https://doi.org/10.1212/WNL.0000000000002715
PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): Study protocol for a randomised controlled trial
Cameron, Jan, Rendell, Peter, Ski, Chantal, Kure, Christina, McLennan, Skye, Rose, Nathan, Prior, David and Thompson, David. (2015). PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): Study protocol for a randomised controlled trial. Trials (online). 16(196), pp. 196 - 209. https://doi.org/10.1186/s13063-015-0721-2
Prospective memory impairment in chronic heart failure
Habota, Tina, McLennan, Skye, Cameron, Jan, Henry, Julie, Ski, Chantal, Thompson, David and Rendell, Peter. (2015). Prospective memory impairment in chronic heart failure. Journal of the International Neuropsychological Society. 21(3), pp. 183 - 192. https://doi.org/10.1017/S1355617715000119
Stroke unit Nurse Managers’ views of individual and organisational factors liable to influence evidence-based practice : A survey
Drury, Peta, McInnes, Elizabeth, Hardy, Jennifer, Dale, Simeon and Middleton, Sandy. (2015). Stroke unit Nurse Managers’ views of individual and organisational factors liable to influence evidence-based practice : A survey. International Journal of Nursing Practice. 22(2), pp. 169-178. https://doi.org/10.1111/ijn.12396
Triage, treatment and transfer : Evidence-based clinical practice recommendations and models of nursing care for the first 72 hours of admission to hospital for acute stroke
Middleton, Sandy, Grimley, Rohan and Alexandrov, Anne. (2015). Triage, treatment and transfer : Evidence-based clinical practice recommendations and models of nursing care for the first 72 hours of admission to hospital for acute stroke. Stroke. 46(2), pp. e18-e25. https://doi.org/10.1161/STROKEAHA.114.006139
An investigation of emotion recognition and theory of mind in people with chronic heart failure
Habota, Tina, McLennan, Skye N., Cameron, Jan, Ski, Chantal F., Thompson, David R. and Rendell, Peter G.. (2015). An investigation of emotion recognition and theory of mind in people with chronic heart failure. PLoS ONE. 10(11), pp. 1 - 13. https://doi.org/10.1371/journal.pone.0141607
Cognitive impairment in heart failure: towards a consensus on screening
Cameron, Jan, Pressler, Susan, Ski, Chantal and Thompson, David. (2014). Cognitive impairment in heart failure: towards a consensus on screening. European Journal of Heart Failure. 16(3), pp. 235 - 237. https://doi.org/10.1002/ejhf.12
Health service management study for stroke : A randomized controlled trial to evaluate two models of stroke care
Chan, Daniel K.Y., Levi, Chris, Cordato, Dennis, O'Rourke, Fintan, Chen, Jack, Redmond, Helen, Xu, Ying-Hua, Middleton, Sandy, Pollack, Michael and Hankey, Graeme. (2014). Health service management study for stroke : A randomized controlled trial to evaluate two models of stroke care. International Journal of Stroke. 9(4), pp. 400-405. https://doi.org/10.1111/ijs.12240
Development of the Heart Failure Screening Tool (Heart-FaST) to measure barriers that impede engagement in self-care
Cameron, Janette, Ski, Chantal, McLennan, Skye Nadine, Rendell, Peter, Whitbourn, Rob and Thompson, David. (2014). Development of the Heart Failure Screening Tool (Heart-FaST) to measure barriers that impede engagement in self-care. European Journal of Cardiovascular Nursing. 13(5), pp. 408 - 417. https://doi.org/10.1177/1474515113502461
Trial of a family-based education program for heart failure patients in rural Thailand
Srisuk, Nittaya, Cameron, Janette, Ski, Chantal and Thompson, David. (2014). Trial of a family-based education program for heart failure patients in rural Thailand. BMC Cardiovascular Disorders. 14(173), pp. 1 - 9. https://doi.org/10.1186/1471-2261-14-173
A systematic approach to chronic heart failure care: A consensus statement
Page, Karen, Marwick, Thomas, Lee, Rebecca, Grenfell, Robert, Abhayaratna, Walter, Aggarwal, Anu, Briffa, Tom, Cameron, Janette, Davidson, Patricia and Driscoll, Andrea. (2014). A systematic approach to chronic heart failure care: A consensus statement. Medical Journal of Australia. 201(3), pp. 146 - 150. https://doi.org/10.5694/mja14.00032
Comparison of self-care behaviors of heart failure patients in 15 countries worldwide
Jaarsma, Tiny, Stromberg, Anna, Ben Gal, Tuvia, Cameron, Janette, Driscoll, Andrea, Duengen, Hans-Dirk, Inkrot, Simone, Huang, Tsuey-Yuan, Huyen, Nguyen Ngoc and Kato, Naoko. (2013). Comparison of self-care behaviors of heart failure patients in 15 countries worldwide. Patient Education and Counseling. https://doi.org/10.1016/j.pec.2013.02.017
Prospective memory and chronic heart failure
Habota, Tina, Cameron, Janette, McLennan, Skye, Ski, Chantal, Thompson, David and Rendell, Peter. (2013). Prospective memory and chronic heart failure. BMC Cardiovascular Disorders. 13(63), pp. 1 - 9. https://doi.org/10.1186/1471-2261-13-63
Screening for mild cognitive impairment in patients with heart failure : Montreal Cognitive Assessment versus Mini Mental State Exam
Cameron, Janette, Worrall-Carter, Linda, Page, Karen Nicola, Stewart, Simon and Ski, Chantal. (2013). Screening for mild cognitive impairment in patients with heart failure : Montreal Cognitive Assessment versus Mini Mental State Exam. European Journal of Cardiovascular Nursing. https://doi.org/10.1177/1474515111435606
Mild cognitive impairment, screening, and patient perceptions in heart failure patients
Gallagher, Robyn, Sullivan, Anne, Burke, Rhonda, Hales, Susan, Gillies, Geraldine, Cameron, Jan and Tofler, Geoffrey. (2013). Mild cognitive impairment, screening, and patient perceptions in heart failure patients. Journal of Cardiac Failure. https://doi.org/10.1016/j.cardfail.2013.08.001
Stroke management : Updated recommendations for treatment along the care continuum
Wright, Leah, Hill, Kelvin M., Bernhardt, Julie, Lindley, Richard, Ada, Louise, Bajorek, Beata V., Barber, P. Alan, Beer, Christopher, Golledge, Jonathon, Gustafsson, L., Hersh, D., Kenardy, J., Perry, L., Middleton, S., Brauer, S. G. and Nelson, M. R.. (2012). Stroke management : Updated recommendations for treatment along the care continuum. Internal Medicine Journal. 42(5), pp. 562 - 569. https://doi.org/10.1111/j.1445-5994.2012.02774.x
Doing the simple things well
Middleton, Sandy. (2012). Doing the simple things well. Royal College of Nursing Australia. 19(2), pp. 65-66. https://doi.org/10.1016/j.colegn.2012.04.001
Recognition and referral of depression in patients with heart disease
Worrall-Carter, Linda, Ski, Chantal, Thompson, David, Davidson, Patricia M., Cameron, Janette, Castle, David and Page, Karen Nicola. (2012). Recognition and referral of depression in patients with heart disease. European Journal of Cardiovascular Nursing. 11(2), pp. 231 - 238. https://doi.org/10.1016/j.ejcnurse.2011.04.005
Improving quality of life by increasing outings after stroke : Study protocol for the Out-and-About trial
McClusky, Annie, Ada, Louise, Middleton, Sandy, Kelly, Patrick J., Goodall, Stephen, Grimshaw, Jeremy M., Logan, Pip, Longworth, Mark and Karageorge, A.. (2012). Improving quality of life by increasing outings after stroke : Study protocol for the Out-and-About trial. International Journal of Stroke. 8(1), pp. 54-58. https://doi.org/10.1111/j.1747-4949.2012.00966.x
Symptom recognition in elders with heart failure
Riegel, Barbara, Dickson, Victoria, Cameron, Jan, Johnson, Jerry, Bunker, Stephen, Page, Karen and Worrall-Carter, Linda. (2010). Symptom recognition in elders with heart failure. Journal of Nursing Scholarship. 42(1), pp. 92 - 100. https://doi.org/10.1111/j.1547-5069.2010.01333.x
Self-Care Behaviours and Heart Failure: Does Experience with Symptoms Really Make a Difference?
Cameron, Janette, Worrall-Carter, Linda, Page, Karen and Stewart, Simon. (2010). Self-Care Behaviours and Heart Failure: Does Experience with Symptoms Really Make a Difference? European Journal of Cardiovascular Nursing. 9(2), pp. 92 - 100. https://doi.org/10.1016/j.ejcnurse.2009.10.004
Does cognitive impairment predict poor self-care in patients with chronic heart failure?
Cameron, Janette, Worrall-Carter, Linda, Page, Karen, Riegel, Barbara, Lo, Sing Kai and Stewart, Simon. (2010). Does cognitive impairment predict poor self-care in patients with chronic heart failure? European Journal of Heart Failure. 12(5), pp. 508 - 515. https://doi.org/10.1093/eurjhf/hfq042
The nexus between cognitive function and self-care ablility in patients with chronic heart failure
Cameron, Janette. (2009). The nexus between cognitive function and self-care ablility in patients with chronic heart failure [Thesis]. https://doi.org/10.4226/66/5a95f334c681d
Gender differences in heart failure self-care: A multinational cross-sectional study
Lee, Christopher S., Reigel, Barbara, Driscoll, Andrea, Suwanno, Jom, Moser, Debra K., Lennie, Terry A., Dickson, Victoria V., Cameron, Janette and Worrall-Carter, Linda. (2009). Gender differences in heart failure self-care: A multinational cross-sectional study. International Journal of Nursing Studies. 46(11), pp. 1485 - 1495. https://doi.org/10.1016/j.ijnurstu.2009.04.004
Testing a model of patient characteristics, psychologic status, and cognitive function as predictors of self-care in persons with chronic heart failure
Cameron, Janette, Worrall-Carter, Linda, Riegel, Barbara, Lo, Sing Kai and Stewart, Simon. (2009). Testing a model of patient characteristics, psychologic status, and cognitive function as predictors of self-care in persons with chronic heart failure. Heart & Lung: the journal of acute and critical care. 38(5), pp. 410 - 418. https://doi.org/10.1016/j.hrtlng.2008.11.004
Measuring self-care in chronic heart failure: A review of the psychometric properties of clinical instruments
Cameron, Janette, Worrall-Carter, Linda, Driscoll, Andrea and Stewart, Simon. (2009). Measuring self-care in chronic heart failure: A review of the psychometric properties of clinical instruments. The Journal of Cardiovascular Nursing. 24(6), pp. E10 - E22. https://doi.org/10.1097/JCN.0b013e3181b5660f
Heart failure self-care in developed and developing countries
Riegel, Barbara, Driscoll, Andrea, Suwanno, Jom, Moser, Debra K., Lennie, Terry A., Chung, Misook L., Wu, Jia-Rong, Dickson, Victoria Vaughan, Carlson, Beverley and Cameron, Janette. (2009). Heart failure self-care in developed and developing countries. Journal of Cardiac Failure. 15(6), pp. 508 - 516. https://doi.org/10.1016/j.cardfail.2009.01.009
Extent of heart failure self-care as an endpoint to patient education: A review of the literature
Cameron, Jan, Worrall-Carter, Linda, Driscoll, Andrea, New, G. and Stewart, Simon. (2007). Extent of heart failure self-care as an endpoint to patient education: A review of the literature. British Journal of Cardiac Nursing. 2(4), pp. 188 - 197.
Prognostic importance of cognitive impairment in chronic heart failure patients : Does specialist disease management make a difference?
McLennan, Skye, Pearson, Sue, Cameron, Janette and Stewart, Simon. (2006). Prognostic importance of cognitive impairment in chronic heart failure patients : Does specialist disease management make a difference? European Journal of Heart Failure. 8(5), pp. 494 - 501. https://doi.org/10.1016/j.ejheart.2005.11.013