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Trial registered on ANZCTR


Registration number
ACTRN12618001468213
Ethics application status
Approved
Date submitted
26/07/2018
Date registered
31/08/2018
Date last updated
10/05/2024
Date data sharing statement initially provided
6/08/2019
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)
U1111-1206-7237
Trial acronym
ReCAPS
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
Ischaemic
Stroke 305091 305091 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In hospital component (All participants before randomisation): Participants have their baseline assessments completed either in hospital, or shortly after discharge by phone, with the hospital clinicians or clinician researchers if e-consent given. For the baseline assessment, consented participants are asked questions about their medical history, current health status and preference for receiving SMS or email communication 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 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. All participants are provided with a summary copy of their SMART goals. 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: Participants are given an opportunity to review and prioritise their goals with the the clinician researcher. They may revise or add new goals to a maximum of 5, if original goals are no longer relevant. The LUNS questionnaire helps to identify unmet needs and may be used in discussion between the clinician researcher and the participant in revising or prioritising their goals, and/or tailoring relevant messages. 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
Active

Outcomes
Primary outcome [1] 304268 0
The primary endpoint is the proportion of participants with emergency department presentations or unplanned hospital readmissions within 90 days of study randomisation collected from 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 (planned/elective and unplanned): 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

Eligibility
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 Service within 10-14 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
Sex
Both males and females
Can healthy volunteers participate?
No
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) Site Principle Investigator deems participant inappropriate due to requirement for surgical intervention within 12-weeks of discharge from hospital

Study design
Purpose of the study
Prevention
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
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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 principles. 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: To investigate whether the trial intervention reduces the proportion of participants with at least one hospital presentation (emergency presentation or admission) within 90 days post randomisation, we will use random effects logistic regression. The primary outcome will be the dependent variable, group allocation the independent variable and hospital the random effect (to account for potential heterogeneity in treatment effects).
Secondary outcomes:
A per-protocol analysis is planned for those who completed 80% or more of the intervention to which they were randomised. Descriptive statistics will be used to compare outcome measures for each group. Multivariable statistical models (as appropriate for the outcome measure, generalised linear, logistic, quantile or negative binomial regression) will be used. Secondary outcomes will be the dependent variables, group allocation the independent variable and the baseline scores for the secondary outcomes will serve as the covariates: 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). .
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
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
3/09/2018
Actual
22/11/2018
Date of last participant enrolment
Anticipated
Actual
29/12/2023
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
890
Accrual to date
Final
466
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
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] 19104 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 19106 0
Maroondah Hospital - Ringwood East
Recruitment hospital [11] 19108 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [12] 22269 0
Logan Hospital - Meadowbrook
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] 33663 0
5000 - Adelaide
Recruitment postcode(s) [10] 33665 0
3135 - Ringwood East
Recruitment postcode(s) [11] 33667 0
6150 - Murdoch
Recruitment postcode(s) [12] 33668 0
6150 - Murdoch
Recruitment postcode(s) [13] 37431 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 298242 0
Government body
Name [1] 298242 0
Victorian State Government: Department of Health and Human Services
Country [1] 298242 0
Australia
Funding source category [2] 298244 0
University
Name [2] 298244 0
Monash University
Country [2] 298244 0
Australia
Funding source category [3] 303502 0
Government body
Name [3] 303502 0
National Health and Medical Research Council
Country [3] 303502 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 297359 0
None
Name [1] 297359 0
Address [1] 297359 0
Country [1] 297359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299250 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 299250 0
Ethics committee country [1] 299250 0
Australia
Date submitted for ethics approval [1] 299250 0
21/03/2018
Approval date [1] 299250 0
03/05/2018
Ethics approval number [1] 299250 0
RES-18-0000-170A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79790 0
Prof Dominique Cadilhac
Address 79790 0
Stroke and Ageing Research Group
Level 2 - Monash University
Victorian Heart Hospital
631 Blackburn Road
Clayton VIC 3168
Country 79790 0
Australia
Phone 79790 0
+61 3 7511 1865
Fax 79790 0
Email 79790 0
dominique.cadilhac@monash.edu
Contact person for public queries
Name 79791 0
Jan Cameron
Address 79791 0
Stroke and Ageing Research Group
Level 2 - Monash University
Victorian Heart Hospital
631 Blackburn Road
Clayton VIC 3168
Country 79791 0
Australia
Phone 79791 0
+61 3 75111969
Fax 79791 0
Email 79791 0
jan.cameron@monash.edu
Contact person for scientific queries
Name 79792 0
Dominique Cadilhac
Address 79792 0
Stroke and Ageing Research Group
Level 2 - Monash University
Victorian Heart Hospital
631 Blackburn Road
Clayton VIC 3168
Country 79792 0
Australia
Phone 79792 0
+61 3 75111969
Fax 79792 0
Email 79792 0
dominique.cadilhac@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3500Informed consent form  dominique.cadilhac@monash.edu
3502Ethical approval  dominique.cadilhac@monash.edu
3503Statistical analysis planKilkenny MF, Olaiya MT, Cameron J, et al. Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial. Trials 2024; 25: 78. DOI: 10.1186/s13063-023-07864-2. dominique.cadilhac@monash.edu
3504Clinical study report  dominique.cadilhac@monash.edu
3505Study protocolCadilhac, D. A., et al. (2022). "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 17(2): 236-241. dominique.cadilhac@monash.edu



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA mixed-methods feasibility study of a new digital health support package for people after stroke: the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) intervention.2022https://dx.doi.org/10.1186/s40814-022-01197-8
EmbaseProtocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).2022https://dx.doi.org/10.1177/17474930211022678
EmbaseTelehealth for rehabilitation and recovery after stroke: State of the evidence and future directions.2022https://dx.doi.org/10.1177/17474930211062480
EmbaseStatistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial.2024https://dx.doi.org/10.1186/s13063-023-07864-2
N.B. These documents automatically identified may not have been verified by the study sponsor.