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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)
Scientific title
Randomised controlled clinical trial of a 12 week discharge self-management support package with use of personalised electronic messages for patients with stroke to reduce unplanned hospital presentations or readmissions and to improve patient self-efficacy (ReCAPs Trial).
Secondary ID [1] 293625 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Inspiring Virtual Enabled Resources following Vascular Events (iVERVE): Sub-study (pilot) to develop and alpha test the intervention used in this trial. Citation: Cadilhac DA, Busingye D, Li J, Andrew NE, et al. Development of an electronic health message system to support recovery after stroke: Inspiring Virtual Enabled Resources following Vascular Events (iVERVE). Patient Preference and Adherence 2018:12 1213–1224 DOI: 10.2147/PPA.S154581

Health condition
Health condition(s) or problem(s) studied:
Stroke 305896 0
Disability 305897 0
Mood disorders 305899 0
Secondary cerebrovascular events 305901 0
Condition category
Condition code
Stroke 305090 305090 0 0
Stroke 305091 305091 0 0

Study type
Description of intervention(s) / exposure
In hospital component (All participants before randomisation): Before a participant is discharged home from hospital, they are asked questions about their medical history, current health status and preference for receiving SMS or email communication as part of a baseline assessment by a trained clinician researcher. The clinician researcher, using the ReCAPS structured goal setting menu designed for this project, will assist recruited participants to identify two to five goals for recovery including at least one focused on preventing another stroke that they want to work towards achieving over 12 weeks. They will record the participants goal statement e.g. "to lose weight". This interview, including goal identification, will take about an hour to complete. All participants are given a paper-based copy of their goal statements and informed that a Monash University researcher will contact them via phone (or video-conference) in the first 7-14 days after their discharge from hospital to clarify their goals. The participants indicate their preferred day and time of the day (e.g. morning, afternoon, evening) for this telephone/video call.
Within 7-14 days of discharge: A researcher from Monash University will contact all participants to ask them questions about their hospital stay (discharge satisfaction [PREPARED] and longer-term unmet needs [LUNS] questionnaires) and reconfirm willingness to participate. Using the standardised ReCAPS goal setting package, the researcher will assist the participant to restructure each of their stated goals to ensure they meet SMART requirements i.e. specific, measurable, achievable, realistic and time-bound. This interview may take 60 minutes to complete and can be undertaken over 2 sessions, if the participant wishes. Participants are then randomly assigned to receive one of the two support programs for 12 weeks. The number of support messages will vary depending on which group the participant has been allocated. Within 7 days following the 7-14 day phone/video call ALL participants receive a welcome message “Hi #PREF_NAME, welcome to the ReCAPS study. We will be contacting you using this number. Please add 'ReCAPS' to your contacts. Thanks ReCAPS team”.
Intervention group: Based on the participant’s finalised goals, the researcher will personalise (use preferred name where possible) and tailor (aligned to stage of readiness and baseline characteristics including disability level, where relevant) the program of electronic messages and schedule them to be sent over the 12 week intervention period. The format and content of the messages are the same regardless of whether sent via SMS or email. The number of messages sent will be dependent on the number of goals established. The maximum number of contacts will be twice daily. In general, intervention participants will only receive one message per day, but on two occasions they may also receive one of the follow-up reminder (administrative) messages.
We will monitor the number of participants who engage with SMS/email by responding to messages requesting a response, “Would you like to speak to someone for further information? Or confirm, by reply SMS or email, that you have received our messages.”; the number of times web-links are accessed; the number of ‘STOP’ messages received; number of help desk enquiries. The satisfaction survey administered on completion will capture participants’ feedback as to whether they did not read the messages and if so how many weeks after starting the program this happened and their reasons for not continuing to read messages.
If a participant in either group responds “STOP” they will receive the following message: “Thanks for contacting the ReCAPS team. One of our staff will contact you within 2 business days to clarify your request to stop receiving messages.”
Follow-up assessments (all participants): conducted over the telephone, or by videocall, around week 13 post randomisation whereby health outcome and resource use (cost) questionnaires will be administered. At around 52 weeks post randomisation, the EQ-5D and health care resource utilisation questionnaire will be administered over the phone to enable cost-effectiveness analysis.
Intervention code [1] 299886 0
Treatment: Other
Comparator / control treatment
Participants in the control group will have the goals initially nominated in hospital converted into a SMART goal. They will receive the same number of contacts for the outcome assessment, as the intervention group but will not be provided with access to any tailored electronic self- management support messages. So that patients remain unaware of their group allocation they will receive the same number of administrative /reminder messages as the intervention group, and a message directing them to the Stroke Foundation website where, if they choose to, can obtain additional on-line information about stroke. The electronic messages are sent according to their preferred method of contact (e.g. SMS, email or telephone).
Control group

Primary outcome [1] 304268 0
Hospital contacts: composite outcome of number of self-reported emergency presentations or hospital admissions and, where applicable, verified in participants' medical records from the hospitals where they were recruited.
Data linkage with emergency and hospital administrative data will be obtained to provide objective evidence from any hospital the participant may have attended.
Timepoint [1] 304268 0
90 day post randomisation
Secondary outcome [1] 341435 0
Goal attainment assessed using the Goal Attainment Scale method
Timepoint [1] 341435 0
90 days post randomisation
Secondary outcome [2] 344872 0
Self-efficacy assessed using the Stroke Self-Efficacy Questionnaire
Timepoint [2] 344872 0
90 days post randomisation
Secondary outcome [3] 344873 0
Mood: anxiety and depression using the Hospital Anxiety and Depression Scale
Timepoint [3] 344873 0
90 days post randomisation
Secondary outcome [4] 344874 0
Hospital contacts: composite outcome of number of self-reported emergency presentations or hospital admissions.
Data linkage with emergency and hospital administrative data will be obtained to provide objective evidence from any hospital the participant may have attended.
Timepoint [4] 344874 0
12 months post randomisation
Secondary outcome [5] 344875 0
Health-related Quality of Life (EQ5D)
Timepoint [5] 344875 0
90 days and 12 months post randomisation
Secondary outcome [6] 350578 0
Cost-effectiveness: cost (self-reported resource use +/- administrative health service use data) per Quality Adjusted Life Year (QALY; derived from EQ-5D questionnaire) gained
Timepoint [6] 350578 0
90 days and 12 months post randomisation
Secondary outcome [7] 350580 0
Composite outcome: recurrent stroke, cardiovascular events or deaths (self-reported +/- linkage with administrative data)
Timepoint [7] 350580 0
90 days and 12 months post randomisation
Secondary outcome [8] 351050 0
Education attainment: assessed with the Health Education Impact Questionnaire
Timepoint [8] 351050 0
90 days post randomisation
Secondary outcome [9] 351051 0
Self-management: assessed with the Health Education Impact Questionnaire
Timepoint [9] 351051 0
90 days post randomisation
Secondary outcome [10] 351052 0
Resource utilisation/costs (self-reported resource use +/- linkage with administrative data)
Timepoint [10] 351052 0
90 days and 12 months post randomisation
Secondary outcome [11] 351053 0
Disability; assessed with the modified Rankin Scale
Timepoint [11] 351053 0
90 days post randomisation
Secondary outcome [12] 351054 0
Unmet needs: assessed with the Longer-term Unmet Needs after Stroke (LUNS) questionnaire
Timepoint [12] 351054 0
90 days post randomisation

Key inclusion criteria
Eligible patients will: (i) be aged 18 years or older; (ii) have a confirmed acute stroke; (iii) be discharged directly to a home setting from a participating Stroke Unit within 10 days of admission; (iv) have access to the internet (can be via public access i.e. local library) or a mobile phone; (v) self-identify as users of SMS/email technology; (vi) be able to communicate in English; (vii) have a Modified Rankin Score of 0-4; (viii) ability to provide own consent and (ix) be likely to survive to 90 days post randomisation, i.e. not being palliated or have illnesses such as terminal cancer.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
a) Unlikely to survive to 90 days post randomisation i.e. not being palliated or have illnesses such as terminal cancer; or b) discharged to another hospital/institution or in-hospital rehabilitation following acute care; c) planned readmission within 3 weeks of index stroke admission, for surgical intervention as preventative management of stroke e.g. carotid endarterectomy

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation occurs using the online system through REDCap (1:1 ratio), stratified by age (<65 or 65+ years), level of disability as determined by baseline modified Rankin Scale [none (score 0-2), moderate-severe (score 3-4)].
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Intervention fidelity in the ReCAPS study will be assessed throughout the trial at the research-team level and the practitioner-patient level. Intervention fidelity will be monitored throughout the trial by an external research team to the Monash Coordinating Office (located within the School of Clinical Sciences) who will observe goal setting procedures, observe telephone interviews, review dispatch logs from the electronic messaging gateway and review the conduct of the follow-up assessments. In addition, study documentation will be regularly reviewed to understand missing and adapted processes.
The intervention fidelity procedures have been developed to address five mains areas, in accordance with recommendations by Bellg et al (Health Psychol. 2004;23(5):443-51): (a) study design, (b) training documents and processes, (c) delivery of the ReCAPS intervention, (d) receipt of intervention as per protocol, and (e) adaptations that occur to any protocol processes throughout the study.
The planned process evaluation will be used to evaluate mechanisms of impact focused on how intervention activities, and participants’ interactions with them, triggered change, using constructs such as participants’ responses, mediators, unintended consequences, and measurable indicators. Evaluation of the context will also be undertaken to examine how external factors influenced the delivery of the ReCAPs intervention. Together, these constructs will ensure data are collected to enable future implementation of ReCAPS to be described at the completion of the trial and as part of the dissemination of findings. This scalability evaluation will be guided by the RE-AIM Conceptual Framework.[Glasgow RE, et al. Am J Public Health. 1999;89(9):1322-7; Austin G, et al. Health Promot Pract. 2011;12(6):932-41] Key concepts of the RE-AIM framework that underpin scalability include reach, effectiveness, and adoption.
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
We will publish a statistical analysis plan prior to final data collection.
Phase II: Descriptive statistics will be used to describe the pilot cohort and other quantitative feasibility data. Qualitative thematic analysis will be used for open text responses obtained as part of the process evaluation.
Phase III: Once the outcomes for n=668 patients are obtained, an adaptive sample size estimation procedure will be undertaken as per the “promising zone” methodology Mehta and Pocock [Stat Med. 2011;30(28):3267-84] with the maximum sample size capped at 1100. A statistician blind to group allocation will oversee the data analysis.
Descriptive statistics will be used to describe the trial population at baseline and to examine between group differences using appropriate methods for the type of data. Within group changes will be examined using McNemar’s test and between group differences will be examined using parametric or non-parametric methods appropriate to the distribution of the data. Primary analyses will be based on intention-to-treat. A secondary per-protocol analysis will also be performed in which only those who completed 80% or more of the intervention to which they were randomised (i.e. remained in the study for at least 10 weeks) will be analysed.
Primary outcome: Descriptive statistics (e.g. Chi-square test) will be used to compare presentations/readmissions to hospital within 3 months post discharge for each intervention group. Random effects multi-level logistic regression models will be used with presentations/readmissions to hospitals (dichotomised as Yes/No) as the dependent variable, intervention groups as the independent variable and the level hospital. The potential for heterogeneity of treatment effects across hospitals will be examined using appropriate random effects regression models (with hospital as the random effect). Where appropriate, multivariable statistical models will also be used to adjust for baseline differences between the intervention and control groups for baseline variables with a p-value of <0.05.
Secondary outcomes:
Descriptive statistics (e.g. t-test, Kruskal Wallis test) will be used to compare patient outcomes for each intervention group. Patient outcomes will be assessed using multi-level (hospital and patient), multivariable statistical models. Where appropriate, multivariable statistical models described below will also adjust for baseline differences between the intervention and control groups for baseline variables with a p-value of <0.05.
Generalised linear (GLM), logistic, quantile or negative binomial regression models will be used with the secondary outcome as the dependent variable, intervention groups as the independent variable and the baseline secondary outcome will serve as the covariate. GLM will be used for the following outcomes: Health Education Impact Questionnaire (HeiQ], Stroke Self-Efficacy Questionnaire (SSEQ) and Hospital Anxiety Depression Scale (HADS). Logistic regression will be used for the dimensions of the EuroQoL-5D -3L, modified Rankin Scale and the dichotomous outcome of the Longer-term Unmet Needs (LUNS). Quantile regression will be used for the visual analogue scale (VAS) of the EuroQoL-5D -3L. Negative binomial regression for the count outcome of Longer-term Unmet Needs (LUNS).
Missing data: Treatment of missing data will be based on the satisfiability of missingness at random assumptions, and will be based on the intention to treat strategy as per White et al.[BMJ. 2011;342:d40]

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 9577 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 9578 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 9579 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 9580 0
Frankston Hospital - Frankston
Recruitment hospital [5] 9581 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [6] 9582 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 11417 0
The Alfred - Prahran
Recruitment hospital [8] 11421 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [9] 11423 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [10] 14450 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [11] 14451 0
Mackay Base Hospital - Mackay
Recruitment hospital [12] 14452 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment hospital [13] 14453 0
Logan Hospital - Meadowbrook
Recruitment hospital [14] 14454 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [15] 14455 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [16] 14456 0
Lismore Base Hospital - Lismore
Recruitment postcode(s) [1] 18333 0
3168 - Clayton
Recruitment postcode(s) [2] 18334 0
3128 - Box Hill
Recruitment postcode(s) [3] 18335 0
3084 - Heidelberg
Recruitment postcode(s) [4] 18336 0
3199 - Frankston
Recruitment postcode(s) [5] 18337 0
2010 - Darlinghurst
Recruitment postcode(s) [6] 18338 0
4575 - Birtinya
Recruitment postcode(s) [7] 23330 0
3004 - Prahran
Recruitment postcode(s) [8] 23334 0
2050 - Camperdown
Recruitment postcode(s) [9] 23336 0
3550 - Bendigo
Recruitment postcode(s) [10] 27465 0
2444 - Port Macquarie
Recruitment postcode(s) [11] 27466 0
4740 - Mackay
Recruitment postcode(s) [12] 27467 0
3280 - Warrnambool
Recruitment postcode(s) [13] 27468 0
4131 - Meadowbrook
Recruitment postcode(s) [14] 27469 0
3220 - Geelong
Recruitment postcode(s) [15] 27470 0
2065 - St Leonards
Recruitment postcode(s) [16] 27471 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 298242 0
Government body
Name [1] 298242 0
Victorian State Government: Department of Health and Human Services
Address [1] 298242 0
50 Lonsdale St, Melbourne Victoria 3001
Country [1] 298242 0
Funding source category [2] 298244 0
Name [2] 298244 0
Monash University
Address [2] 298244 0
School of Clinical Sciences at Monash Health
Level 3, Block E, Monash Medical Centre
246 Clayton Road Clayton VIC 3168
Country [2] 298244 0
Funding source category [3] 303502 0
Government body
Name [3] 303502 0
National Health and Medical Research Council
Address [3] 303502 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [3] 303502 0
Primary sponsor type
Monash University
Wellington Road
Clayton VIC 3168
Secondary sponsor category [1] 297359 0
Name [1] 297359 0
Address [1] 297359 0
Country [1] 297359 0

Ethics approval
Ethics application status
Ethics committee name [1] 299250 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 299250 0
Level 2, i Block
Monash Medical Centre
246 Clayton Road
Ethics committee country [1] 299250 0
Date submitted for ethics approval [1] 299250 0
Approval date [1] 299250 0
Ethics approval number [1] 299250 0

Brief summary
About 1 in 3 stroke survivors experience an emergency presentation or unplanned readmission within 90 days of discharge from hospital. Unplanned readmissions are associated with poorer quality of life, depression and poorer functional status. In addition to the impact of hospitalisation on survivors and their families, there is a substantial economic impact. While the factors precipitating an unplanned readmission are complex, common precipitating factors include: poorer mental health, poorer functional status, and infections. These factors are related to poor preparation of survivors and their carers for the transition from hospital to home; and a lack of ongoing support to assist with self-managing the sequelae of stroke.
Methods: Randomised controlled trial to assess the impact of an innovative dischagre support program comprising (a) standardised goal setting prior to hospital discharge plus (b) integrated e-health self-management support, to reduce unplanned presentations/ readmissions among survivors of stroke within 90 days.
Significance: This will be the first adequately powered and rigorous trial of an e-health intervention to improve discharge care and support. Findings will be important nationally and internationally, for all adults discharged from hospital with a newly-acquired disability, not just survivors of stroke.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 79790 0
Prof Dominique Cadilhac
Address 79790 0
Level 3 Hudson Institute Building
27-31 Wright Street
Clayton VIC 3168
Country 79790 0
Phone 79790 0
+61 3 8572 2657
Fax 79790 0
Email 79790 0
Contact person for public queries
Name 79791 0
Dr Jan Cameron
Address 79791 0
Level 3 Hudson Institute Building
27-31 Wright Street
Clayton VIC 3168
Country 79791 0
Phone 79791 0
+61 3 8572 2657
Fax 79791 0
Email 79791 0
Contact person for scientific queries
Name 79792 0
Prof Dominique Cadilhac
Address 79792 0
Level 3 Hudson Institute Building
27-31 Wright Street
Clayton VIC 3168
Country 79792 0
Phone 79792 0
+61 3 8572 2657
Fax 79792 0
Email 79792 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
What data in particular will be shared?
On completion of publications by the Investigators and ReCAPS collaborators, anonymised data will be available for secondary research purposes such as pooling data for meta analysis of similar studies, or complimentary research questions.
IPD that has been linked with health department information will not be made available.
When will data be available (start and end dates)?
Anticipated from 2027, no end date determined.
Available to whom?
Academics and students
Available for what types of analyses?
Research questions that do not replicate our primary and secondary outcome analyses
How or where can data be obtained?
Direct contact with the Coordinating Principal Investigator, Professor Dominique Cadilhac
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3500 0
Informed consent form
Citation [1] 3500 0
Link [1] 3500 0
Email [1] 3500 0
Other [1] 3500 0
Attachment [1] 3500 0
Type [2] 3502 0
Ethical approval
Citation [2] 3502 0
Link [2] 3502 0
Email [2] 3502 0
Other [2] 3502 0
Attachment [2] 3502 0
Type [3] 3503 0
Statistical analysis plan
Citation [3] 3503 0
Link [3] 3503 0
Email [3] 3503 0
Other [3] 3503 0
Attachment [3] 3503 0
Type [4] 3504 0
Clinical study report
Citation [4] 3504 0
Link [4] 3504 0
Email [4] 3504 0
Other [4] 3504 0
Attachment [4] 3504 0
Type [5] 3505 0
Study protocol
Citation [5] 3505 0
Link [5] 3505 0
Email [5] 3505 0
Other [5] 3505 0
Attachment [5] 3505 0
Summary results
No Results