Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001401145
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
14/10/2019
Date last updated
18/01/2023
Date data sharing statement initially provided
14/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of RESET (Resuming Employment after Stroke: Enhancement through Tele-coordination)
Scientific title
A feasibility study of RESET (Resuming Employment after Stroke: Enhancement through Tele-coordination)
Secondary ID [1] 299398 0
Nil Known
Universal Trial Number (UTN)
U1111-1240-9346
Trial acronym
RESET-A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Stroke 314573 0
Condition category
Condition code
Stroke 312911 312911 0 0
Ischaemic
Stroke 312912 312912 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 313012 313012 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. A letter will be sent to the participant’s nominated GP/specialist informing them of their study participation.
2. RESET: The RESET program links participants with a RESET Coordinator who will support their return to work goals for up to six months post stroke. The program is delivered remotely which means it can be offered to people who might not be able to attend face-to-face meetings due to distance, time or convenience. The RESET Coordinator will meet with the person via telephone or teleconference to determine a return to work plan, and then continue to provide follow up support and ensure referrals and linkage with appropriate services, organisations and stakeholders (covering all aspects including health, financial, employment and social supports).
The RESET intervention will be delivered for up to 6 months post stroke. There is no limit to number of or duration of sessions delivered in that time frame as long as return to work/staying at work remains the central goal. All interactions with the client and other stakeholders will be documented in the RESET Service Record, which will be audited at the end of the study. For this study the intervention will be delivered by either university researchers or by the existing Stroke Association of Victoria Stay at Work Initiative Coordinator.
Intervention code [1] 315650 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321509 0
Intervention satisfaction as measured by the Client Service Questionnaire-8
Timepoint [1] 321509 0
6 months post stroke
Primary outcome [2] 321511 0
Acceptability of test procedures and assessment measures assessed using qualitative interviews (20 minute one-on-one telephone interviews)
Timepoint [2] 321511 0
Baseline, 3 and 6 (primary endpoint) months post-stroke.
Primary outcome [3] 321512 0
Intervention acceptability as measured by qualitative interviews (20 minute one-on-one telephone interviews)
Timepoint [3] 321512 0
3 and 6 (primary endpoint) months post stroke
Secondary outcome [1] 375190 0
Employment rate (defined as work for one hour or more (per week) for pay, profit, commission or payment in kind, in a job or business or on a farm (employees and owner managers of incorporated or unincorporated enterprises), or without pay in a family business or on a farm (contributing family workers)), calculated using data collected via questions adapted from the Australian Bureau of Statistics Census Form.
Timepoint [1] 375190 0
6 months post stroke
Secondary outcome [2] 375191 0
Depression symptoms, as measured by the PHQ-9
Timepoint [2] 375191 0
Baseline to 6 months
Secondary outcome [3] 375192 0
Anxiety symptoms as measured by the GAD-7
Timepoint [3] 375192 0
Baseline and 6 months post-stroke
Secondary outcome [4] 375193 0
Quality of life as measured by the the AQOL-4D
Timepoint [4] 375193 0
Baseline and 6 months post-stroke
Secondary outcome [5] 375194 0
Fatigue, as measured by the Neurological Fatigue Index for Stroke
Timepoint [5] 375194 0
Baseline and 6 months post-stroke

Eligibility
Key inclusion criteria
Inclusion criteria
(1) aged 18-75 years;
(2) diagnosed with stroke in last 2.5 months. Diagnoses include ICD-11 diagnoses (or equivalent, depending on local coding systems) of Intracerebral haemorrhage, Subarachnoid haemorrhage, Cerebral ischemic stroke, or Stroke not known if ischaemic or haemorrhagic;
(3) meet criteria of employment prior to stroke (1 hour or more per week for pay/profit/commission/ payment in kind or in a family business).);
(4) Reside in Victoria.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
(1) Currently engaged in WorkCover;
(2) No ready access to a telephone;
(3) Inability to complete informed consent or research procedures (including due to factors including lack of capacity, insufficient English, significant aphasia);
(4) Acute suicidality or medical instability.
(5) Pregnancy (will be referred for appropriate supports)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given the feasibility aim of the study, analyses will be primarily descriptive providing means/medians and variance, or n (%) of responses to satisfaction questions. The proposed primary and secondary outcome measures for the effectiveness trial will be calculated, with rates or change over time measured to give an indication of effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/10/2019
Actual
4/11/2019
Date of last participant enrolment
Anticipated
14/03/2022
Actual
3/06/2022
Date of last data collection
Anticipated
30/06/2022
Actual
18/11/2022
Sample size
Target
45
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 14851 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 19781 0
Western District Health Service - Hamilton - Hamilton
Recruitment hospital [3] 19782 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment hospital [4] 21758 0
Albury Wodonga Health - Albury campus - Albury
Recruitment postcode(s) [1] 28114 0
3220 - Geelong
Recruitment postcode(s) [2] 34425 0
3300 - Hamilton
Recruitment postcode(s) [3] 34426 0
3280 - Warrnambool
Recruitment postcode(s) [4] 36812 0
2640 - Albury

Funding & Sponsors
Funding source category [1] 303905 0
University
Name [1] 303905 0
Deakin University
Country [1] 303905 0
Australia
Funding source category [2] 308923 0
Charities/Societies/Foundations
Name [2] 308923 0
Stroke Foundation
Country [2] 308923 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
IMPACT SRC, Level 3 HERB B Building
PO Box 281
Geelong, Victoria, 3220
Country
Australia
Secondary sponsor category [1] 304053 0
None
Name [1] 304053 0
Address [1] 304053 0
Country [1] 304053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304411 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 304411 0
Ethics committee country [1] 304411 0
Australia
Date submitted for ethics approval [1] 304411 0
26/06/2019
Approval date [1] 304411 0
12/09/2019
Ethics approval number [1] 304411 0
19/91
Ethics committee name [2] 310371 0
Albury Wodonga Health Human Research Ethics Committee
Ethics committee address [2] 310371 0
Ethics committee country [2] 310371 0
Australia
Date submitted for ethics approval [2] 310371 0
27/07/2021
Approval date [2] 310371 0
28/09/2021
Ethics approval number [2] 310371 0
486/21/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96858 0
Dr Alyna Turner
Address 96858 0
IMPACT, Deakin University Level 3 HERB B Building, Barwon Health PO Box 281 Geelong, Victoria, 3220
Country 96858 0
Australia
Phone 96858 0
+61342153313
Fax 96858 0
Email 96858 0
[email protected]
Contact person for public queries
Name 96859 0
Alyna Turner
Address 96859 0
IMPACT, Deakin University Level 3 HERB B Building, Barwon Health PO Box 281 Geelong, Victoria, 3220
Country 96859 0
Australia
Phone 96859 0
+61342153313
Fax 96859 0
Email 96859 0
[email protected]
Contact person for scientific queries
Name 96860 0
Alyna Turner
Address 96860 0
IMPACT, Deakin University Level 3 HERB B Building, Barwon Health PO Box 281 Geelong, Victoria, 3220
Country 96860 0
Australia
Phone 96860 0
+61342153313
Fax 96860 0
Email 96860 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
Given the feasibility nature of the study no formal data sharing plan has been made (as assessments may change as a result of feedback from participants or researchers), however if the team are approached for data sharing in the period before the raw data is destroyed, Barwon Health HREC will be consulted.


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.