Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10025
Study information
Scientific title
Return To Work after stroke: a feasibility randomised controlled trial (RCT) and economic analysis
Acronym
RTW
Study hypothesis
This investigation aims to work with people with stroke and their employers to develop a model of vocational rehabilitation for people with recent stroke, define and cost the components of this model of vocational rehabilitation and establish the most appropriate measures of 'intangible' benefit (quality of life, well-being, self efficacy, stroke impact) for this intervention so that the intervention can be evaluated formally in a randomised controlled trial using both cost-effectiveness and cost benefit as outcomes.
Ethics approval
Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 19/05/2010, ref: 10/H0406/21
Study design
Single-centre single-blind randomised feasibility clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Can be found at http://www.clahrc-ndl.nihr.ac.uk/our-themes/clinical-themes/stroke-rehabilitation/return-to-work-after-stroke_20
Condition
Stroke
Intervention
Stroke specific vocational rehabilitation (intervention arm):
The interventional arm involves an individually tailored process of case management, liaison, guidance and counselling, coaching, mentoring and occupational therapy delivered on a one to one basis by our research occupational therapist. The total contact will vary between clients depending on their specific difficulties and clinical needs but we would generally expect less than 10 sessions per client. The vocational rehabilitation intervention is based on a developing evidence base - with good quality research previously conducted employing this approach to the treatment of clients with other long term neurological conditions and we are now testing this approach's efficacy as applied to supporting stroke survivors.
Treatment as usual (control arm):
The treatment as usual arm involves full and active participation in NHS, Social services, or 3rd sector provision just as the patient would receive anyway irrespective of trial participation.
Follow up for both arms is at 3 and 6 months only.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Occupational status (working or not, hours worked and current income band)
2. Benefit status
Measured by postal questionnaire, sent to participants at 3 months and 6 months from the point of trial registration.
Secondary outcome measures
Standardised measures of:
1. Mood
2. Instrumental ADL (NEADL)
3. Disability
4. Stroke severity
5. Quality of life
6. Work
7. Participation (Sydney Psychosocial Reintegration Scale)
8. Cognitions
Measured by postal questionnaire, sent to participants at 3 months and 6 months from the point of trial registration.
Overall trial start date
15/07/2010
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. People of working age, either sex
2. Living in Derby cities and Southern Derbyshire Health Communities
3. Have suffered a stroke
4. Were working or in full time education at stroke on-set
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
52
Participant exclusion criteria
1. People not of working age
2. People not living in the catchment area
3. People who have not had a diagnosis of stroke confirmed
4. People who were not in full time education or working at the on-set of their stroke
Recruitment start date
15/07/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Nottingham
Nottingham
NG7 2RH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care - Nottinghamshire, Derbyshire and Lincolnshire (CLAHRC NDL)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list