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Trial registered on ANZCTR


Registration number
ACTRN12618001519246
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
11/09/2018
Date last updated
11/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inspiring Virtual Enabled Resources following Vascular Events (iVERVE) pilot randomised controlled trial in chronic stroke to determine the feasibility and acceptability of e-health support after stroke.
Scientific title
Inspiring Virtual Enabled Resources following Vascular Events (iVERVE) pilot (Phase I) randomised controlled trial in chronic stroke to determine the feasibility and acceptability of e-health support after stroke.
Secondary ID [1] 295054 0
Nil Known
Universal Trial Number (UTN)
U1111-1219-7265
Trial acronym
iVERVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 308097 0
Condition category
Condition code
Stroke 307139 307139 0 0
Ischaemic
Stroke 307140 307140 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this pilot study we aim to test the components of a personalised electronic self-management support intervention to support patient-centred goal attainment and secondary prevention following stroke. This novel support program comprises: structured and comprehensive patient-centred goal setting conducted over the phone in survivors of stroke recruited from the Australian Stroke Survivor Clinical Registry (AuSCR) 1-2 years (medium time 16 months; Q1:12 months to Q3:18 months) from admission. All participants will be assisted by a researcher to develop 2-3 goals for recovery or secondary prevention of stroke, via telephone. Goals are chosen from a menu specifically developed for the study consisting of 5 major categories and 32 sub-categories related to the International Classification of Functioning Disability and Health and secondary prevention. For example they may select to address secondary prevention of stroke and establish a goal directed at controlling blood pressure. Once the goals have been established, participants will then be randomised. The intervention group will receive electronic health messages sent via the iVERVE messaging system and aligned to their goals over 4 weeks. Prior to being sent electronic messages to support attainment of their goals, they receive 2 general administrative messages e.g. "Hi #PREF_NAME, welcome to the iVERVE study. We will be contacting you using this number. Please add 'iVERVE' to your contacts. Thanks". Electronic messages will then be scheduled over the 4 week intervention period. They will be personalised (use preferred name where possible) and tailored (aligned to stage of readiness and baseline characteristics including disability level, where relevant) 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. They will also receive one or two general motivational message per week e.g. "Hi #PREF_NAME, the beginning is always the hardest part. iVERVE is going to help you find your get up and go! You can do it!" The number of messages sent will be dependent on the number of goals established but the maximum number per week will be 7. The mode of delivery is chosen by the participant. Some messages will contain hyperlinks to reliable and trusted websites for participants to obtain further information. One reminder message regarding the the final follow-up assessment will be sent after the 4 week intervention, using the participants preferred method of delivery.


Intervention code [1] 301387 0
Lifestyle
Intervention code [2] 312285 0
Behaviour
Intervention code [3] 312286 0
Prevention
Comparator / control treatment
Participants in the control group will also be assisted by a researcher to develop to develop 2-3 goals for recovery or secondary prevention of stroke, via telephone. Similar to the intervention group, they will receive 2 general administrative messages via the iVERVE messaging system prior to being sent electronic messages over 4 weeks. The electronic messages they will receive will consist of general administrative messages e.g. “Hi #PREF_NAME, do you have any concerns with the messages you are receiving from iVERVE? Please reply Yes or No. Thanks"'”. To maintain blinding they will also be given information on where to get additional information online about stroke and provided with details of the Stroke Foundation website e.g. “For more advice on stroke prevention, treatment and recovery do not hesitate to call Strokeline on 1800 787 65. They may be able to offer further advice”. One reminder message regarding the the final follow-up assessment will be sent after the 4 week intervention, using the participants preferred method of delivery.
Control group
Active

Outcomes
Primary outcome [1] 306094 0
Number of participants that complete the trial
Timepoint [1] 306094 0
5 weeks post randomisation
Primary outcome [2] 306095 0
Group differences in Goal attainment Scale as assessed by changes in the baseline and follow-up mean T-score
Timepoint [2] 306095 0
5 weeks post randomisation
Primary outcome [3] 307278 0
Number of participants satisfied with the program using a study specific questionnaire with a combination of questions seeking responses on a 5 point Likert scale and open ended questions
Timepoint [3] 307278 0
1-2 weeks post the followup assessment (~7 weeks post randomisation)
Secondary outcome [1] 347561 0
Group differences in self-efficacy measured with the validated Health Education Impact Questionnaire (HeiQ).
Timepoint [1] 347561 0
5 weeks post randomisation
Secondary outcome [2] 347562 0
Group differences in emotional status assessed by the validated Hospital Anxiety and Depression Scale (HADS).
Timepoint [2] 347562 0
5 weeks post randomisation
Secondary outcome [3] 347564 0
Group difference in Health related quality of life will be assessed by the EuroQoL-5D.
Timepoint [3] 347564 0
5 weeks post randomisation
Secondary outcome [4] 351349 0
Intervention dose (number of SMS/email messages successfully sent) assessed by accessing system analytics
Timepoint [4] 351349 0
4 weeks post randomisaiton
Secondary outcome [5] 351350 0
Cost of maintaining the iVERVE interface and sending messages assessed by accessing program operational financial data
Timepoint [5] 351350 0
4 weeks post randomisation
Secondary outcome [6] 351351 0
Satisfaction with content of ehealth messages using a study specific questionnaire for the intervention group with a combination of questions seeking responses on a 5 point Likert scale and open ended questions
Timepoint [6] 351351 0
5 weeks post randomisation

Eligibility
Key inclusion criteria
Inclusion criteria will be people registered in AuSCR who:
• are aged at least 18 years;
• agreed to participate in future research at their 90-180 day follow-up interview;
• are 6-12 months post-discharge from acute care hospital;
• are living in the community (but not residential aged care facilities) within 50 km of Monash University (Monash Health, Clayton campus); and
• have English as their first language or do not require a translator
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to communicate in English
Severe cognitive impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer. Allocation concealment was conducted using the randomisation module in REDCap (https://apps.icts.uiowa.edu/confluence/display/REDCapDocs/REDCap+Randomization+Module)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (1:1 ratio) stratified by age (<65 or 65+ years), level of disability as determined by baseline modified Rankin Scale[none (score0-1), moderate (score 2-3), severe (score 4) using a randomisation table created by Excel.
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
Qualitative (focus group) and process evaluation included
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We have nominated a pragmatic sample size suitable for a feasibility study and similar to that used in other pilot work in this area. It is anticipated that we will be able to obtain sufficient information from this sample size to determine if our intervention is acceptable and feasible whilst also providing some early signals for patient effectiveness related to health outcomes.
Primary analysis will use intention to treat analysis i.e. participants will be analysed in the treatment group to which they were randomised regardless of whether or not they received the intervention. A secondary per-protocol analysis will also be performed in which only those who completed the treatment to which they were originally allocated will be analysed. Success in achieving health related goals and changes in health outcomes, self-efficacy and prescribed secondary prevention medication adherence between intervention and control groups will be assessed to provide preliminary evidence for a larger, well powered randomised controlled trial. After completion of the intervention period, success in achieving the set goals will be assessed using GAS methods in which GAS outcome T-scores will be compared with change from baseline. Scores will also be weighted based on the difficulty of achieving the goal and the importance of the goal to the patient.
Descriptive statistics will be used to describe the trial population at baseline. 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. Where feasible, 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 <0.2.
Results will be used in sample size calculations for the larger planned Phase III study. The e-health activity of participants, i.e. number of times web-links were accessed and the most frequently used platform (email or SMS) will also be assessed.
The quantitative and qualitative data will be used to fine-tune the intervention. As part of this process the findings from each aspect of the project will be triangulated as part of the interpretative process. Triangulation is the combination of at least two or more theoretical perspectives, methodological approaches, data sources, investigators, or data analysis methods. The intent of using triangulation is to decrease, negate, or counterbalance the deficiency of a single strategy, thereby increasing the ability to interpret the findings. This is particularly useful in pilot studies whereby formative program evaluation techniques as outlined in this protocol are being used.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Pilot study and sufficient participant numbers were reached to test the safety and feasibility of the trial protocol and intervention arms
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)
VIC

Funding & Sponsors
Funding source category [1] 299637 0
University
Name [1] 299637 0
Monash University
Address [1] 299637 0
School of Clinical Sciences at Monash Health,
Level 5, Block E, Monash Medical Centre,
246 Clayton Road, Clayton, Victoria 3168
Country [1] 299637 0
Australia
Primary sponsor type
Individual
Name
Monash University
Address
Wellington Road, Clayton Victoria, 3168
Country
Australia
Secondary sponsor category [1] 298961 0
None
Name [1] 298961 0
Address [1] 298961 0
Country [1] 298961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300535 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 300535 0
Room 111, Chancellery Building E, 24 Sports Walk, Monash Clayton Campus, Wellington Rd, Clayton , Victoria 3800
Ethics committee country [1] 300535 0
Australia
Date submitted for ethics approval [1] 300535 0
03/04/2016
Approval date [1] 300535 0
30/06/2016
Ethics approval number [1] 300535 0
CF16-1920-2016000979

Summary
Brief summary
Approximatey 50, 000 Australians suffer a new stroke each year. Survivors of stroke often leave hospital unprepared for life back in the community and without support to assist in their transition from hospital to home and self-managing the sequelae of stroke. Using a randomised controlled design, this pilot study will test a novel personalised electronic self-management support intervention consisting (a) standardised patient-centred goal setting (b) integrated e-health self-management support following stroke.
Significance: We will determine the feasibility of the proposed intervention in a sample of survivors of stroke and obtain data to inform the design of Phase II and Phase III studies targeting patients with acute stroke who are discharged home from hospital.
Trial website
Trial related presentations / publications
Initial messaging infrastructure development: Development of an electronic health message system to support recovery after stroke: Inspiring Virtual Enabled Resources following Vascular Events (iVERVE). Patient Prefer Adherence. 2018; 12: 1213–1224. Published online 2018 Jul 11. doi: 10.2147/PPA.S154581
Public notes

Contacts
Principal investigator
Name 83978 0
Prof Dominique Cadilhac
Address 83978 0
Head: Translational Public Health and Evaluation Division
Stroke and Ageing Research
Department of Medicine
School of Clinical Sciences at Monash Health
Monash University
Level 3 Hudson Institute Building
27-31 Wright Street
Clayton VIC 3168

Country 83978 0
Australia
Phone 83978 0
+61 3 8572 2657
Fax 83978 0
Email 83978 0
Dominique.Cadilhac@monash.edu
Contact person for public queries
Name 83979 0
Prof Dominique Cadilhac
Address 83979 0
Head: Translational Public Health and Evaluation Division
Stroke and Ageing Research
Department of Medicine
School of Clinical Sciences at Monash Health
Monash University
Level 3 Hudson Institute Building
27-31 Wright Street
Clayton VIC 3168

Country 83979 0
Australia
Phone 83979 0
+61 3 8572 2657
Fax 83979 0
Email 83979 0
Dominique.Cadilhac@monash.edu
Contact person for scientific queries
Name 83980 0
Prof Dominique Cadilhac
Address 83980 0
Head: Translational Public Health and Evaluation Division
Stroke and Ageing Research
Department of Medicine
School of Clinical Sciences at Monash Health
Monash University
Level 3 Hudson Institute Building
27-31 Wright Street
Clayton VIC 3168

Country 83980 0
Australia
Phone 83980 0
+61 3 8572 2657
Fax 83980 0
Email 83980 0
Dominique.Cadilhac@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary