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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]

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

Condition category

Condition code

Stroke

Ischaemic

Stroke

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

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]

Number of participants that complete the trial

Timepoint [1]

5 weeks post randomisation

Primary outcome [2]

Group differences in Goal attainment Scale as assessed by changes in the baseline and follow-up mean T-score

Timepoint [2]

5 weeks post randomisation

Primary outcome [3]

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]

1-2 weeks post the followup assessment (~7 weeks post randomisation)

Secondary outcome [1]

Group differences in self-efficacy measured with the validated Health Education Impact Questionnaire (HeiQ).

Timepoint [1]

5 weeks post randomisation

Secondary outcome [2]

Group differences in emotional status assessed by the validated Hospital Anxiety and Depression Scale (HADS).

Timepoint [2]

5 weeks post randomisation

Secondary outcome [3]

Group difference in Health related quality of life will be assessed by the EuroQoL-5D.

Timepoint [3]

5 weeks post randomisation

Secondary outcome [4]

Intervention dose (number of SMS/email messages successfully sent) assessed by accessing system analytics

Timepoint [4]

4 weeks post randomisaiton

Secondary outcome [5]

Cost of maintaining the iVERVE interface and sending messages assessed by accessing program operational financial data

Timepoint [5]

4 weeks post randomisation

Secondary outcome [6]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

3/05/2017

Date of last participant enrolment

Anticipated

Actual

8/08/2017

Date of last data collection

Anticipated

Actual

14/09/2017

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

School of Clinical Sciences at Monash Health,
Level 5, Block E, Monash Medical Centre,
246 Clayton Road, Clayton, Victoria 3168

Country [1]

Australia

Primary sponsor type

Individual

Name

Monash University

Address

Wellington Road, Clayton Victoria, 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Room 111, Chancellery Building E, 24 Sports Walk, Monash Clayton Campus, Wellington Rd, Clayton , Victoria 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/04/2016

Approval date [1]

30/06/2016

Ethics approval number [1]

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

Prof Dominique Cadilhac

Address

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

Australia

Phone

+61 3 8572 2657

Fax

[email protected]

Contact person for public queries

Name

Prof Dominique Cadilhac

Address

Country

Australia

Phone

+61 3 8572 2657

Fax

[email protected]

Contact person for scientific queries

Name

Prof Dominique Cadilhac

Address

Country

Australia

Phone

+61 3 8572 2657

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Pilot randomised clinical trial of an eHealth, self-management support intervention (iVERVE) for stroke: feasibility assessment in survivors 12-24 months post-event.	2020	https://dx.doi.org/10.1186/s40814-020-00706-x
Dimensions AI	Research Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry	2024	https://doi.org/10.1016/j.jphys.2024.02.015

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically