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Stroke Self-Management Rehabilitation Trial (SMART)

Prospective, open-label, randomised, multicentre, pilot clinical trial involving about 700 stroke survivors to (a) explore the feasibility of recruitment and likely level of support required to uptake the intervention; (b) to inform the power calculation, identify the inclusion criteria and best primary outcome measure for conducting a full-scale randomised controlled trial; and (c) to assess preliminary efficacy of a DVD-based observational learning intervention in stroke survivors for improving their functional outcomes at 3 months after randomisation.

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001287820
Acronym
SMART
Enrollment
66
Registered
2012-12-12
Start date
2013-05-01
Completion date
2014-10-31
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Stroke is a major health problem in New Zealand and internationally. Current educational tools for stroke survivors and their caregivers remain inadequate and there are major gaps in the ability of the existing educational tools to transfer knowledge about stroke risk factors, warning symptoms, treatment, caregiving and rehabilitation. New technology allows more personal, engaging educational strategies that can be delivered interactively. This randomised controlled trial is to assess the feasibility of a novel observational learning DVD-based educational intervention in stroke survivors and their caregivers as a potentially applicable strategy to improve the function of stroke survivors as well as the health and well-being of both survivors and informal carers. Should this unique role model DVD-based observational learning tool be effective in improving outcomes in stroke patients and their caregivers, it will be a significant advance in stroke care.

Interventions

The role model observational learning tool for stroke recovery and coping (in DVD format) is based on best available evidence, including educational materials and books endorsed by the New Zealand Stroke Foundation, National Stroke Foundation of Australia, the World Federation for Neurorehabilitation and the World Stroke Organization. The DVDs will be provided by the New Zealand Stroke Education Charitable Trust. The observational learning intervention DVD menu includes common areas of post-stro

The role model observational learning tool for stroke recovery and coping (in DVD format) is based on best available evidence, including educational materials and books endorsed by the New Zealand Stroke Foundation, National Stroke Foundation of Australia, the World Federation for Neurorehabilitation and the World Stroke Organization. The DVDs will be provided by the New Zealand Stroke Education Charitable Trust. The observational learning intervention DVD menu includes common areas of post-stroke care and rehabilitation/adaptation. The choice of the most relevant items for each participant will be based on patient-oriented goals as per discussion with and recommendations by the rehabilitation specialist or clinician involved in the trial at the time of randomisation (based upon a standard interview of about 1 hour duration). Stroke survivors and their family caregivers (when available) will be encouraged to watch all or particular sections of the DVD video clips showing rehabilitation, care and/or coping strategies (as instructed by the rehabilitation specialist at the interview) to achieve the identified goal(s) as often as needed but no less than twice a week (1 hour on each occasion) during the first month after discharge, once a week during the second month, and fortnightly during the third month after randomisation. The first DVD educational session of about 1 hour duration with some instructions (if required) will be carried out in-person at the time of randomisation. The participants will be offered an opportunity to phone the rehabilitation specialist should they have a question, whenever it is deemed feasible by the rehabilitation specialist, to maximize tailoring of the intervention to the participant’s needs/goals. The overall duration of the study intervention will be 3 months. The frequency of each participant's self-rehabilitation sessions may differ on a case by case basis but the duration of the each session should be about 1 hour. The self-rehabilitation sessions will not be supervised by the health professional (except for the first session at baseline). Participants assigned to usual care will not receive DVDs but may be given some recommendations by the rehabilitation therapist at the time of the interview as they would have normally receive from a rehabilitation specialist. All study participants will receive their usual care from their treating physicians and health specialists.

Sponsors

National Institute for Stroke & Applied Neurosciences, AUT University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

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

Inclusion criteria

All consecutive patients with stroke admitted to participating centers will be potentially eligible for inclusion in the study if they meet all the following inclusion criteria: (1) clinically diagnosed stroke with some level of disability; (2) discharged home; and (3) availability of home DVD-player. All such patients and their informal (unpaid) caregiver (next of kin or the person providing most day-to-day support, whenever available) will be approached couple days before or after their discharge to home but no later than 9 months after the stroke onset.

Exclusion criteria

inability to communicate (including non-fluent English), history of previous disabling stroke (pre-stroke MRS 3-5), living outside the study area, admission to hospital from a residential care facility or rest home, inability to provide informed consent, participation in another clinical trial, significant cognitive impairment that would affect their understanding of the instructions and compliance with the intervention (by opinion of the treating physician or rehabilitation specialist at the time of the interview), or history of alcoholism, drug abuse, or serious mental illness (e.g. depression, psychosis, bipolar disorder).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026