Condition category
Circulatory System
Date applied
26/02/2018
Date assigned
13/03/2018
Last edited
13/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Every year 110,000 people in England have a stroke, 25% of which are of working age. For many, a primary goal is to return to work, yet fewer than 50% of those working at stroke onset do. Being in work benefits personal finances, mood, lifestyle and relationships. Current rehabilitation after stroke aims to help people to be able to live independently, but does not focus on helping them back into work. Vocational Rehabilitation (VR) involves helping people find work, prevent job loss and support career progression despite disability. Early Stroke Specialist Vocational Rehabilitation (ESSVR) seeks to lessen the impact of stroke by assessing the patient’s role as a worker and finding acceptable strategies to overcome problems.

Who can participate?
Stroke survivors aged 18 and over who were employed at stroke onset and their carers (if applicable)

What does the study involve?
Participants are randomly allocated to receive ESSVR or usual care. ESSVR is delivered by a stroke specialist occupational therapist who is trained to assess the impact of the stroke on the participant and their job; coordinate appropriate support from NHS, employer and other stakeholders; negotiate workplace adjustments, monitor return to work and explore alternatives where current work is not feasible or cannot be sustained. It is tailored to individual needs. Usual care is the usual NHS rehabilitation provided by the usual care team, which may involve outpatient/community physio, speech or occupational therapy, psychology, and medical follow-up. The intervention lasts for as long as is needed up to 12 months. Participants are followed up by postal/online questionnaire at 3, 6 and 12 months. The success of ESSVR is measured by the number of stroke survivors who are in employment (paid or unpaid) for a minimum of 2 hours at 12 months. Changes in mood, physical function, community integration, quality of life, work self-efficacy, post-stroke confidence, the number of NHS services needed for participants, changes in the numbers and types of negative events participants experience (for example admission to hospital) are also measured.

What are the possible benefits and risks of participating?
This study aims to improve rehabilitation services for people in employment who have had a stroke. It is hoped that this study will help to support people who have had a stroke in returning to work. No disadvantages or risks are expected. Any appointments are arranged at times to suit the participants.

Where is the study run from?
University of Leeds (UK)

When is the study starting and how long is it expected to run for?
July 2017 to November 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Vicki McLellan

Trial website

Contact information

Type

Scientific

Primary contact

Ms Vicki McLellan

ORCID ID

Contact details

Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
Level 11 Worsley Building
University of Leeds
Leeds
LS2 9JT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37304

Study information

Scientific title

Early vocational rehabilitation compared with usual care for stroke survivors: an individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations

Acronym

RETAKE

Study hypothesis

Every year 110,000 people in England have a stroke, 25% of which are of working age. For many, a primary goal is to return to work yet fewer than 50% of those working at stroke onset do. Being in work benefits personal finances, mood, lifestyle and relationships. Current rehabilitation after stroke aims to help people to be able to live independently, but does not focus on helping them back into work. Vocational Rehabilitation (VR) involves helping people find work, prevent job loss and support career progression despite disability.

Ethics approval

East Midlands – Nottingham 2 Ethics Committee, 22/01/2018, ref: 18/EM/0019

Study design

Randomised; Both; Design type: Treatment, Complex Intervention, Rehabilitation, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Stroke, Primary sub-specialty: Rehabilitation; UKCRC code/ Disease: Stroke/ Cerebrovascular diseases

Intervention

This study will involve 760 stroke survivors (420 ESSVR plus usual care, 340 usual care alone), who are employed at stroke onset, and their carers (if applicable). Two occupational therapists from 20 UK hospitals will receive training in the Early Stroke Specialist Vocational Rehabilitation (ESSVR). ESSVR seeks to lessen the impact of stroke by assessing the patient’s role as a worker and finding acceptable strategies to overcome problems. ESSVR is individually tailored to participants’ needs, starting within eight weeks of stroke, with dose and intensity as needed.

The Early Stroke Specialist Vocational Rehabilitation (ESSVR) model (intervention) will be compared to a usual care (control) group:

Intervention group: ESSVR will be delivered by a stroke specialist occupational therapist (OT) who is trained to assess the impact of the stroke on the participant and their job; coordinate appropriate support from NHS, employer and other stakeholders; negotiate workplace adjustments, monitor return to work and explore alternatives where current work is not feasible or cannot be sustained. It will be tailored to individual needs.

Usual care (UC) group: Usual NHS rehabilitation provided by usual care team. This may involve outpatient/community physio-, speech- or occupational- therapy, psychology, medical follow-up.

The intervention will commence within 2 weeks of randomisation and last for as long as is needed up to 12 months post-randomisation. Participants will be followed up by postal/online questionnaire at 3, 6 and 12 months post-randomisation. The success of ESSVR will primarily be measured by the number of stroke survivors who are in employment (paid or unpaid) for a minimum of 2 hours at 12 months post-randomisation. Secondary outcomes will also include changes in mood, physical function, community integration, quality of life, work self-efficacy, post-stroke confidence, the number of NHS services needed for participants, changes in the numbers and types of negative events participants experience (for example admission to hospital).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Self-reported return to work of at least 2 hours per week at 12 months post randomisation. This may be a return to a pre-stroke job or a new job. This will be recorded as a positive response to the question: ‘Are you currently in work(paid or unpaid) for at least 2 hours per week?’; Timepoint(s): 12 months post-randomisation

Secondary outcome measures

All secondary outcomes are measured at 3, 6 and 12 months:
1. Work-related outcomes: return to work with same employer, number of hours worked, number of days in work
2. Mood, assessed using the Hospital Anxiety & Depression Scale (HADS) anxiety and depression scores
3. Physical function, assessed using the Nottingham Extended Activities of Daily Living scale (NEADL) summary score
4. Social participation, assessed using the Community Integration Questionnaire (CIQ) social and productivity scores
5. Work self-efficacy, measured using a single question from the work ability index
6. Health-related quality of life, measured using the EuroQoL 5 dimension health questionnaire, 5 level (EQ-5D-5L)
7. Health and social care resource use and wider resource use (e.g. productivity, personal or carer costs): self reported A&E attendances, hospital admission/readmission, number of work accidents, overall health and social care resource use, measured using a bespoke patient completed resource use questionnaire
8. Post-stroke confidence, measured using the Confidence after Stroke Measure (CaSM) summary score

Process Evaluation
Intervention compliance and how the intervention is experienced and understood by providers and recipients, and the organisational implications of embedding and sustaining the intervention in preparation for wider NHS roll-out. Measured using an embedded mixed-methods process evaluation using a range of methods including observations, qualitative interviews with participants, carers, service providers and employers, non-participant observation in sites, document analysis (case records and intervention proformas) and care mapping in a random sample of cases (up to 5% of participants in both ESSVR and UC)

Internal Pilot (8 Sites)
Recruitment rates at 4 – 6 months post randomisation and follow-up rates after 12 months post-randomisation, to assess whether they meet the predefined progression criteria thresholds

Overall trial start date

01/07/2017

Overall trial end date

30/11/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age ≥18 years
2. Admitted to hospital with new stroke (all severities)
3. In work at stroke onset (including self-employed, paid or unpaid)
4. Willing and have capacity to provide informed consent to participate in the study
5. Have sufficient proficiency in English to contribute to the data collection required for research

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 760; UK Sample Size: 760

Participant exclusion criteria

Not intending to work

Recruitment start date

01/04/2018

Recruitment end date

31/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Nottingham

Sponsor details

c/o Ms Angela Shone
East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 15/130/11

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/11/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes