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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.

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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001519246
Acronym
iVERVE
Enrollment
68
Registered
2018-09-11
Start date
2017-05-03
Completion date
2017-08-08
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. Al

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.

Sponsors

Monash University
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Unable to communicate in English Severe cognitive impairment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026