Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12618000044224
Ethics application status
Approved
Date submitted
12/12/2017
Date registered
15/01/2018
Date last updated
16/07/2019
Date data sharing statement initially provided
16/07/2019
Date results provided
16/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The Reablement from Stroke Obtained via a Rehabilitation and Employment Service Trial
Query!
Scientific title
A Prototype for a Randomised Controlled Trial Comparing Usual Care with Individualised Case Management for the Rehabilitation of Employed Stroke Patients and the effects on Health and Vocational Outcomes and Long Term Public Sector Costs
Query!
Secondary ID [1]
292130
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1197-0753
Query!
Trial acronym
RESTORES Trial
Query!
Linked study record
Not applicable
Query!
Health condition
Health condition(s) or problem(s) studied:
Mild Stroke
303558
0
Query!
Condition category
Condition code
Public Health
305149
305149
0
0
Query!
Health service research
Query!
Stroke
305150
305150
0
0
Query!
Haemorrhagic
Query!
Stroke
305290
305290
0
0
Query!
Ischaemic
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
A Case Manager, who is an Allied Health Professional with a post graduate qualification in vocational rehabilitation, will carry out an individual needs assessment with the participant within 15 days of their randomisation. Depending on the timeliness of the participant's discharge, this process may happen in the hospital setting (pre or post discharge), in the Case Manager's place of work, or in the participant's home if preferred.
The needs assessment, which usally takes 1.5 hours to complete, aims to establish participant centred goals, as well as to understand the barriers that are hindering the participant returning to work, conducting leisure activities and carrying out daily life tasks.
Based on this assessment, the Case Manager will arrange rehabilitation and vocational services to meet the individual participant's needs. For example, this might include access to a clinical exercise physiologist, a speech language therapist, a business mentor or a driving assessor. Again, some of these services will be delivered in a participant's home and some at the provider's place of work. The Case Manager will also work closely with the participant's GP and employer.
The Case Manager will contact the participant at least fortnightly to assess their needs, review their progress and discuss recommendations. The mode of contact will be mutually agreed between the Case Manager and the participant and could be via phone or face to face in either the participant's home or the Case Manager's place of work. Depending on the participant's needs, this fortnightly catch up could last between 15 minutes and an hour.
The Case Manager will work closely with each participant for up to one year.
Query!
Intervention code [1]
299849
0
Rehabilitation
Query!
Comparator / control treatment
The control participants will receive the standard care for a mild stroke patient presenting at Auckland City, Waitakere or North Shore Hospitals. This usually involves a short hospital stay, involving clinical assessment and rehabilitation, with a referral to their GP on discharge.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
304220
0
Return-to-work rates as captured by the Case Manager for intervention participants and the Research Therapist for standard care participants. Note - all employment - be it paid or unpaid, part time or full time, will be captured for the purposes of the Prototype so as to inform the future Randomised Controlled Trial.
Query!
Assessment method [1]
304220
0
Query!
Timepoint [1]
304220
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Secondary outcome [1]
341277
0
Health related quality of life using EQ5D.
Query!
Assessment method [1]
341277
0
Query!
Timepoint [1]
341277
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Secondary outcome [2]
341280
0
Function using the Modified Rankin Scale.
Query!
Assessment method [2]
341280
0
Query!
Timepoint [2]
341280
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Secondary outcome [3]
341281
0
Cognitive function using the Montreal Cognitive Assessment.
Query!
Assessment method [3]
341281
0
Query!
Timepoint [3]
341281
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Secondary outcome [4]
341282
0
Mood using the Patient Health Questionnaire (PHQ-9).
Query!
Assessment method [4]
341282
0
Query!
Timepoint [4]
341282
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Secondary outcome [5]
341283
0
Disability and dependence using The National Institutes of Health Stroke Scale (NIHSS).
Query!
Assessment method [5]
341283
0
Query!
Timepoint [5]
341283
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Secondary outcome [6]
341810
0
Disability and dependence using the 30-Second Chair Stand Test.
Query!
Assessment method [6]
341810
0
Query!
Timepoint [6]
341810
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Secondary outcome [7]
341811
0
Disability and dependence using the Mayo-Portland Adaptability Inventory-4.
Query!
Assessment method [7]
341811
0
Query!
Timepoint [7]
341811
0
At one year after randomisation (measurements also taken at baseline and 6 months)
Query!
Eligibility
Key inclusion criteria
1. The patient has been diagnosed with mild stroke by a consultant responsible for his or her care, with that diagnosis being recorded in the patient’s record.
2. The patient was in paid employment prior to the stroke with paid employment being defined as working for 60 hours or more at a pay rate at or above the national minimum wage in the fortnight prior to the onset of the stroke (or in receipt of paid leave of those hours and at that pay rate);
3. The patient is a NZ citizen or permanent resident or holding a residence class visa and ordinarily resident in NZ including at the time of the stroke.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
60
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Moderate and severe stroke – as defined by a NIHSS score of 9 or higher at the time of recruitment. Patients who have a higher score that drops during the course of their admission become eligible if the score is below 9 within two weeks of stroke onset. Patients with moderate to severe stroke or severe stroke are expected to have a low probability of recovery to a point that would permit them to return to work within the one year study period.
2. Subarachnoid haemorrhage – A review by the Cochrane Collaboration has recommended that trials of rehabilitation interventions in stroke exclude patients with subarachnoid haemorrhage owing to the differences in natural history and management with this condition.
3. Patients with disability insurance – These patients would be likely to receive some form of intervention if they hold income or disability insurance with a private insurance company and hence it would not be possible to randomly allocate them to “usual care”.
4. Pregnancy. It is difficult to assess the impact of a return to work intervention on (working) pregnant women because a significant proportion will receive paid parental leave of up to one year from the birth of the child. Their inclusion in RESTORES might therefore bias the outcome estimates downwards in intention-to-treat analyses.
5. Patients eligible for Accident Compensation Corporation (ACC) funded treatment. These will include patients with stroke due to trauma (e.g. through traumatic carotid artery dissections) or due to treatment injury.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed opaque envelopes will be used for randomisation.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation using a randomisation table created by computer software was used for sequence generation.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Data will be analysed on an intention to treat basis. The initial analysis of data will test for any deviations from balance between the two groups by comparing the distribution of basic demographic variables in each. Multivariate regression methods will be used to control for confounding due to socio-demographic factors that are not distributed evenly between intervention and control group despite the randomisation. If necessary multiple imputation by chained equations methods will be applied to avoid bias introduced by missing data.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
22/01/2018
Query!
Actual
15/01/2018
Query!
Date of last participant enrolment
Anticipated
22/06/2018
Query!
Actual
11/06/2018
Query!
Date of last data collection
Anticipated
21/06/2019
Query!
Actual
21/06/2019
Query!
Sample size
Target
22
Query!
Accrual to date
Query!
Final
22
Query!
Recruitment outside Australia
Country [1]
9429
0
New Zealand
Query!
State/province [1]
9429
0
Auckland
Query!
Funding & Sponsors
Funding source category [1]
296668
0
Government body
Query!
Name [1]
296668
0
Ministry of Social Development
Query!
Address [1]
296668
0
P O Box 1556
Wellington 6140
Query!
Country [1]
296668
0
New Zealand
Query!
Primary sponsor type
Government body
Query!
Name
Waitemata District Health Board
Query!
Address
Private Bag 93-503
Takapuna 0740
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
295627
0
None
Query!
Name [1]
295627
0
Query!
Address [1]
295627
0
Query!
Country [1]
295627
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
297893
0
Northern B Health and Disability Ethics Committee
Query!
Ethics committee address [1]
297893
0
PO Box 5013. Wellington 6140
Query!
Ethics committee country [1]
297893
0
New Zealand
Query!
Date submitted for ethics approval [1]
297893
0
13/06/2017
Query!
Approval date [1]
297893
0
05/07/2017
Query!
Ethics approval number [1]
297893
0
17/NTB/111
Query!
Summary
Brief summary
The RESTORES Trial Prototype (n=20) will be delivered in preparation for a future Randomised Controlled Trial (n=300). RESTORES is a new social investment initiative, funded by the Ministry of Social Development, which will provide additional case managed rehabilitation services to people in the workforce who experience a mild stroke, with a view to helping them return to work and retain employment.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
75386
0
Prof Cathy Stinear
Query!
Address
75386
0
The University of Auckland
Private Bag 92019
Auckland 1142
Query!
Country
75386
0
New Zealand
Query!
Phone
75386
0
+64 21 077 0788
Query!
Fax
75386
0
Query!
Email
75386
0
[email protected]
Query!
Contact person for public queries
Name
75387
0
Sarah Masson
Query!
Address
75387
0
Waitemata DHB
Private Bag 93-503
Takapuna 0740
Query!
Country
75387
0
New Zealand
Query!
Phone
75387
0
+64 21 775 475
Query!
Fax
75387
0
Query!
Email
75387
0
[email protected]
Query!
Contact person for scientific queries
Name
75388
0
Cathy Stinear
Query!
Address
75388
0
The University of Auckland
Private Bag 92019
Auckland 1142
Query!
Country
75388
0
New Zealand
Query!
Phone
75388
0
+64 21 077 0788
Query!
Fax
75388
0
Query!
Email
75388
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Patient data was only collected to be reported on as de-identified data as per the patient information sheet
Query!
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
No additional documents have been identified.
Download to PDF