Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001287820
Ethics application status
Approved
Date submitted
11/12/2012
Date registered
12/12/2012
Date last updated
13/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Stroke Self-Management Rehabilitation Trial (SMART)
Scientific title
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.
Secondary ID [1] 281647 0
Nil known
Universal Trial Number (UTN)
U1111-1137-8422
Trial acronym
SMART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 287932 0
self-management 287933 0
rehabilitation 287934 0
Condition category
Condition code
Stroke 288313 288313 0 0
Ischaemic
Stroke 288314 288314 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286185 0
Rehabilitation
Comparator / control treatment
Participants will be randomly assigned to receive standard stroke educational care or the observational learning intervention DVD plus standard stroke education. The standard stroke education care may vary in each participating centre in terms of the frequency and actual content but may include educational brochures, books, stroke club meetings, discussions with health care providers etc. The overall duration of the standard stroke education care will be the same as for the active self-management intervention (3 months). The sub-set sample (10 treatment/10 control in New Zealand and 10 treatment/10 control in Australia) will be interviewed for a qualitative assessment of the effect of the intervention soon after 3 months after the randomisation (upon completion of the intervention).
Control group
Active

Outcomes
Primary outcome [1] 288485 0
The primary outcome measure in stroke survivors will include the daily Living Self-Efficacy Scale. It will be measured in-person right after randomisation (as baseline assessment) and over the phone or postal questionnaire at 3 months after the randomisation (upon completion of the intervention). The interviewer should be blinded to participant’s allocation at 3 months after the randomisation (upon completion of the intervention).
Timepoint [1] 288485 0
Baseline and at 3 months after randomization
Secondary outcome [1] 300291 0
Secondary outcome measures will include EuroQol (EQ-5D), MRS, and Center for Epidemiologic Studies Depression (CES-D). These outcome measures will be measured in-person right after randomisation and by postal questionnaire or telephone interview (interviewer should be blinded to participant’s allocation) at 3 months after the randomisation (upon completion of the intervention). The compliance with the prescribed regime of watching DVD-based role models will be assessed by self-reporting 3 months after the randomisation (upon completion of the intervention). Outcome measures in caregivers will include the Bakas Caregiver Outcomes Scale measured at 3 months after the randomisation (upon completion of the intervention). A sub-set sample of the participants in selected participating centers (upon agreement with the centers) will also be interviewed for a qualitative assessment of the effect of the intervention soon after 3 months after the randomisation (upon completion of the intervention).
Timepoint [1] 300291 0
3 months after randomization

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned to receive standard stroke educational care or the observational learning intervention DVD plus standard stroke education. The computerised randomisation will be done centrally at the National Institute for Stroke & Applied Neurosciences, AUT University, NZ and delivered to the participating center by email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A stratified minimisation randomisation, stratified by centre, will be used to ensure a balance between the control and intervention groups for major prognostic factors, such as age groups <65; 65+, sex, stroke severity (Modified Rankin Scale, MRS 0-2; 3-5), presence or absence of family caregiver, time passed since stroke onset (<6 months; 6-12 months), and incontinence (yes; no).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Simple incidence rates, relative risks and 95% confidence intervals will be obtained for all binary variables in the first instance, with subsequent multiple logistic regression analysis adjusting for other variables. Continuous data will be analysed using multiple linear regression modelling if normally distributed. Non-parametric analysis will be adopted if data are not normally distributed.
Sensitivity analysis will also be carried out to determine the effect of missing data (for example, missing because patients are lost to follow-up). Secondary analyses will be conducted with outcome rates corrected for any discordance between reported and confirmed compliance with the use of role model educational tools. The consistency of effects for DVD based role model educational tools will also be assessed using tests for heterogeneity.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
1/04/2015
Actual
31/10/2014
Date of last data collection
Anticipated
Actual
31/01/2015
Sample size
Target
700
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment outside Australia
Country [1] 10645 0
United States of America
State/province [1] 10645 0
Emory University

Funding & Sponsors
Funding source category [1] 286448 0
University
Name [1] 286448 0
National Institute for Stroke & Applied Neurosciences, AUT University
Country [1] 286448 0
New Zealand
Primary sponsor type
University
Name
National Institute for Stroke & Applied Neurosciences, AUT University
Address
90 Akoranga Drive, Northcote, Auckland 0627
Country
New Zealand
Secondary sponsor category [1] 285236 0
Charities/Societies/Foundations
Name [1] 285236 0
New Zealand Stroke Education Trust
Address [1] 285236 0
PO Box 36411, Northcote, Auckland 0748
Country [1] 285236 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288529 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 288529 0
Online applications only. The postal address is:
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288529 0
New Zealand
Date submitted for ethics approval [1] 288529 0
15/01/2013
Approval date [1] 288529 0
22/02/2013
Ethics approval number [1] 288529 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36506 0
Prof Valery Feigin
Address 36506 0
National Institute for Stroke & Applied Neurosciences
AUT University
90 Akoranga Drive, Northcote
Auckland 0627
Country 36506 0
New Zealand
Phone 36506 0
+6499219166
Fax 36506 0
+6499219620
Email 36506 0
[email protected]
Contact person for public queries
Name 36507 0
Prof Valery Feigin
Address 36507 0
National Institute for Stroke & Applied Neurosciences
AUT University
90 Akoranga Drive, Northcote
Auckland 0627
Country 36507 0
New Zealand
Phone 36507 0
+6499219166
Fax 36507 0
+6499219620
Email 36507 0
[email protected]
Contact person for scientific queries
Name 36508 0
Prof Valery Feigin
Address 36508 0
National Institute for Stroke & Applied Neurosciences
AUT University
90 Akoranga Drive, Northcote
Auckland 0627
Country 36508 0
New Zealand
Phone 36508 0
+6499219166
Fax 36508 0
+6499219620
Email 36508 0
[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
SourceTitleYear of PublicationDOI
EmbaseMethodology of the stroke self-management rehabilitation trial: An international, multisite pilot trial.2015https://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2014.08.029
EmbaseInformation provision for stroke survivors and their carers.2021https://dx.doi.org/10.1002/14651858.CD001919.pub4
N.B. These documents automatically identified may not have been verified by the study sponsor.