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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
31/08/2018
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.
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): 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 a standardised template and manual for goal setting designed for this project, will also help recruited participants to develop two to five goals for recovery and/or preventing another stroke (e.g. Diabetes management SMART goal: Checks and records blood glucose level daily at home with test kit. Remembers to do this 80% of the time over the past 2 weeks) that they want to work towards achieving. This interview, including goal setting, will take about an hour to complete. All participants are given a paper-based copy of their goals and informed that a different researcher will contact them via phone in the first 7-14 days after their discharge from hospital. The participants indicate their preferred day and time of the day (e.g. morning, afternoon, evening) for this telephone 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. 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 1-2 days following the 7-14 day phone 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” and an admin message with instructions on sending a STOP message.
Intervention group: If randomised to the intervention group the health recovery goals documented in hospital will be systematically reviewed then modified, deleted or new ones added to achieve minimum 2 to maximum 5 goals (may take 10-20 minutes to complete). Then electronic messages will then be personalised (use preferred name where possible) and tailored (aligned to stage of readiness and baseline characteristics including disability level, where relevant) and scheduled to be sent over the 12 week intervention period e.g. Message for a goal to improve memory: “Hi #PREF_NAME, keeping a dairy of appointments or a notebook may help you remember important information.” 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, but they will be contacted at least three times per week. 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. Up to 3 times i.e. once every 3-4 weeks, participants will be asked whether they would like to speak to someone for further information or confirm, by reply SMS or email, that they have received the messages. They may also receive general motivational messages or secondary prevention e.g. "Hi #PREF_NAME, believe in achieving your goals and you’re halfway there. Keep focused and take as many small steps as you need. ReCAPS team.”; "Hi #PREF_NAME, For 3 easy steps that may help reduce your stroke risk download the consumer resource from the Stroke Foundation: bit.ly/2l8e0sn."
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 around week 13 post randomisation whereby health outcome and resource use (cost) questionnaires will be administered. Dependent on securing additional funding, 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
Patients in the control will not have their ReCAPs Recovery Goals documented in hospital, reviewed by the Monash RA at the 7-14 day follow-up. 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. So that patients remain unaware of their group allocation they receive 6 administrative messages: 1) Post randomisation they will be sent a single ‘welcome message’; 2) They will be sent a message about opting out if they received the message in error; 3) In Week 1 they will be sent a message directing them to the Stroke Foundation website where, if they choose to, can obtain additional on-line information about stroke; 4 and 5) Consistent with the intervention arm, they receive two reminder messages for the follow up assessments (one in week 8 and one in week 11); 6) They have a final message in Week 12 indicating this is the last message they will receive. These 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
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.
If funding for data linkage with emergency and hospital administrative data is obtained then this information will also be used 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.
If funding for data linkage with emergency and hospital administrative data is obtained then this information will also be used 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 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
Gender
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

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 recruitment state (Victorian vs other States), 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
Feasibility of implementing the intervention in real-world, clinical trial context will be assessed using various sources of information and additional process data will be captured to enable a full description of the intervention as per TIDiER checklist (Hoffman et al BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1687) to ensure future replication.
Dependent on funding, data linkage will be conducted to enable a cost-effectiveness analysis.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We will publish a statistical analysis plan prior to final data collection. Descriptive statistics will be used to describe the trial population at baseline and to examine between group differences using methods appropriate for the distribution. Primary outcome analyses will be based on intention-to-treat. A secondary analysis using a per-protocol analysis will also be undertaken. Logistic regression models will be used with unplanned presentations/readmission to hospitals (dichotomised as Yes/No) as the dependent variable, intervention groups as the independent variable and baseline Rankin and age as covariates. Linear regression models will be used with the GAS T-score as the dependent variable, intervention groups as the independent variable and the baseline GAS T-score will serve as the covariate. The potential for heterogeneity of treatment effects across centres will be examined using appropriate random effects regression models (with centre as the random effect). Time to first readmission will be examined using competing risks Cox Proportional Hazards Regression modelling with the competing risk being death within 90-days. Multiple imputations will be used subject to the assumptions of data being missing at random. In sub-group analysis we will assess the differences between the intervention and control groups, and between participants with high versus low unmet needs, in achievement of health related goals, self-efficacy, health promotion actions, and self-reported lifestyle behaviour change.
Economic analysis: The cost-effectiveness of the intervention is based on a societal perspective (includes direct health sector, patient out-of-pocket costs, and indirect productivity costs) against a usual care comparator. The incremental cost-effectiveness ratio (ICER) is based on the secondary outcome of HR-QOL and will be the net cost/QALY gained. A protocol for standardised data collection will be used to obtain information from participants about resources used (e.g. number of general practice or allied health visits), costs for new aids and equipment or any new health events requiring medical care. Indirect costs for productive gains/losses will also be assessed. Self-reported data will be supplemented by a separate written consent to obtain linked patient-level emergency, hospital, Medicare, and Pharmaceutical Benefits Scheme data for 12 months pre-stroke admission (to adjust for pre-stroke service utilisation), and 12 months post randomisation. Cost items will be valued for the reference year 2021. The overall ‘program costs’ will be deducted from the potential cost-offsets from fewer readmissions or other resource savings. Sensitivity and uncertainty (probabilistic multivariable [Monte-Carlo simulated]) analyses will be performed to assess the robustness of results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,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] 11416 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [8] 11417 0
The Alfred - Prahran
Recruitment hospital [9] 11418 0
Nambour General Hospital - Nambour
Recruitment hospital [10] 11419 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [11] 11420 0
Cairns Base Hospital - Cairns
Recruitment hospital [12] 11421 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [13] 11422 0
The Northern Hospital - Epping
Recruitment hospital [14] 11423 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [15] 11424 0
John Hunter Hospital - New Lambton
Recruitment hospital [16] 11425 0
Royal Brisbane & Womens Hospital - Herston
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] 23329 0
3050 - Parkville
Recruitment postcode(s) [8] 23330 0
3004 - Prahran
Recruitment postcode(s) [9] 23331 0
4560 - Nambour
Recruitment postcode(s) [10] 23332 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 23333 0
4870 - Cairns
Recruitment postcode(s) [12] 23334 0
2050 - Camperdown
Recruitment postcode(s) [13] 23335 0
3076 - Epping
Recruitment postcode(s) [14] 23336 0
3550 - Bendigo
Recruitment postcode(s) [15] 23337 0
2305 - New Lambton
Recruitment postcode(s) [16] 23338 0
4029 - Herston

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
Australia
Funding source category [2] 298244 0
University
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
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
Level 2, i Block
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
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
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

Contacts
Principal investigator
Name 79790 0
Prof Dominique Cadilhac
Address 79790 0
Level 3 Hudson Institute Building
27-31 Wright Street
Clayton VIC 3168
Australia
Country 79790 0
Australia
Phone 79790 0
+61 3 8572 2657
Fax 79790 0
Email 79790 0
dominique.cadilhac@monash.edu
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
Australia
Country 79791 0
Australia
Phone 79791 0
+61 3 8572 2657
Fax 79791 0
Email 79791 0
jan.cameron@monash.edu
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
Australia
Country 79792 0
Australia
Phone 79792 0
+61 3 8572 2657
Fax 79792 0
Email 79792 0
dominique.cadilhac@monash.edu

No data has been provided for results reporting
Summary results
Not applicable