Return To Work after stroke

ISRCTN	ISRCTN55406009
DOI	https://doi.org/10.1186/ISRCTN55406009
Secondary identifying numbers	10025

Submission date: 26/08/2010
Registration date: 23/09/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Kate Radford
Scientific

Division Rehabilitation and Ageing
School Of Community Health Sciences
University of Nottingham
Nottingham
NG7 2RH
United Kingdom

Study information

Study design	Single-centre single-blind randomised feasibility clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant 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
Scientific title	Return To Work after stroke: a feasibility randomised controlled trial (RCT) and economic analysis
Study acronym	RTW
Study objectives	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(s)	Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 19/05/2010, ref: 10/H0406/21
Health condition(s) or problem(s) studied	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
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 study start date	15/07/2010
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	52
Key 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
Key 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
Date of first enrolment	15/07/2010
Date of final enrolment	31/05/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Nottingham

Nottingham
NG7 2RH
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

Website	http://www.nottingham.ac.uk/ris/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care - Nottinghamshire, Derbyshire and Lincolnshire (CLAHRC NDL)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.