Trial Review

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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 information initially 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
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
Secondary ID [1] 292130 0
Nil known
Universal Trial Number (UTN)
U1111-1197-0753
Trial acronym
RESTORES Trial
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Mild Stroke 303558 0
Condition category
Condition code
Public Health 305149 305149 0 0
Health service research
Stroke 305150 305150 0 0
Haemorrhagic
Stroke 305290 305290 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299849 0
Rehabilitation
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.
Control group
Active

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.
Timepoint [1] 304220 0
At one year after randomisation (measurements also taken at baseline and 6 months)
Secondary outcome [1] 341277 0
Health related quality of life using EQ5D.
Timepoint [1] 341277 0
At one year after randomisation (measurements also taken at baseline and 6 months)
Secondary outcome [2] 341280 0
Function using the Modified Rankin Scale.
Timepoint [2] 341280 0
At one year after randomisation (measurements also taken at baseline and 6 months)
Secondary outcome [3] 341281 0
Cognitive function using the Montreal Cognitive Assessment.
Timepoint [3] 341281 0
At one year after randomisation (measurements also taken at baseline and 6 months)
Secondary outcome [4] 341282 0
Mood using the Patient Health Questionnaire (PHQ-9).
Timepoint [4] 341282 0
At one year after randomisation (measurements also taken at baseline and 6 months)
Secondary outcome [5] 341283 0
Disability and dependence using The National Institutes of Health Stroke Scale (NIHSS).
Timepoint [5] 341283 0
At one year after randomisation (measurements also taken at baseline and 6 months)
Secondary outcome [6] 341810 0
Disability and dependence using the 30-Second Chair Stand Test.
Timepoint [6] 341810 0
At one year after randomisation (measurements also taken at baseline and 6 months)
Secondary outcome [7] 341811 0
Disability and dependence using the Mayo-Portland Adaptability Inventory-4.
Timepoint [7] 341811 0
At one year after randomisation (measurements also taken at baseline and 6 months)

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Concealed opaque envelopes will be used for randomisation.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/01/2018
Actual
15/01/2018
Date of last participant enrolment
Anticipated
22/06/2018
Actual
11/06/2018
Date of last data collection
Anticipated
21/06/2019
Actual
21/06/2019
Sample size
Target
22
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 9429 0
New Zealand
State/province [1] 9429 0
Auckland

Funding & Sponsors
Funding source category [1] 296668 0
Government body
Name [1] 296668 0
Ministry of Social Development
Country [1] 296668 0
New Zealand
Primary sponsor type
Government body
Name
Waitemata District Health Board
Address
Private Bag 93-503
Takapuna 0740
Country
New Zealand
Secondary sponsor category [1] 295627 0
None
Name [1] 295627 0
Address [1] 295627 0
Country [1] 295627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297893 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 297893 0
PO Box 5013.
Wellington 6140
Ethics committee country [1] 297893 0
New Zealand
Date submitted for ethics approval [1] 297893 0
13/06/2017
Approval date [1] 297893 0
05/07/2017
Ethics approval number [1] 297893 0
17/NTB/111

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75386 0
Prof Cathy Stinear
Address 75386 0
The University of Auckland
Private Bag 92019
Auckland 1142
Country 75386 0
New Zealand
Phone 75386 0
+64 21 077 0788
Fax 75386 0
Email 75386 0
[email protected]
Contact person for public queries
Name 75387 0
Ms Sarah Masson
Address 75387 0
Waitemata DHB
Private Bag 93-503
Takapuna 0740
Country 75387 0
New Zealand
Phone 75387 0
+64 21 775 475
Fax 75387 0
Email 75387 0
[email protected]
Contact person for scientific queries
Name 75388 0
Prof Cathy Stinear
Address 75388 0
The University of Auckland
Private Bag 92019
Auckland 1142
Country 75388 0
New Zealand
Phone 75388 0
+64 21 077 0788
Fax 75388 0
Email 75388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Results - Of 19 participants [7 (37%) women, mean ... [More Details]

Documents added automatically
No additional documents have been identified.