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| [ ...Back to search results ] | [ Print-friendly version ] |
| Return To Work after stroke |
| ISRCTN | ISRCTN55406009 |
| ClinicalTrials.gov identifier | |
| Public title | Return To Work after stroke |
| Scientific title | Return To Work after stroke: a feasibility randomised controlled trial (RCT) and economic analysis |
| Acronym | RTW |
| Serial number at source | 10025 |
| 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. |
| Lay summary | |
| Ethics approval | Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1 approved on the 19th May 2010 (ref: 10/H0406/21) |
| Study design | Single centre single blind randomised feasibility clinical trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 15/07/2010 |
| Anticipated end date | 31/05/2012 |
| Status of trial | Ongoing |
| Patient information material | Can be found at http://www.clahrc-ndl.nihr.ac.uk/our-themes/clinical-themes/stroke-rehabilitation/return-to-work-after-stroke_20 |
| Target number of participants | 52 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care - Nottinghamshire, Derbyshire and Lincolnshire (CLAHRC NDL) |
| Trial website | http://www.clahrc-ndl.nihr.ac.uk/our-themes/clinical-themes/stroke-rehabilitation/return-to-work-after-stroke_20 |
| Publications | |
| Contact name | Dr Kate Radford |
| Address |
Division Rehabilitation and Ageing
School Of Community Health Sciences University of Nottingham |
| City/town | Nottingham |
| Zip/Postcode | NG7 2RH |
| Country | United Kingdom |
| Sponsor | University of Nottingham (UK) |
| Address |
Research Innovation Services
Kings Meadow Campus Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Sponsor website: | http://www.nottingham.ac.uk/ris/ |
| Date applied | 26/08/2010 |
| Last edited | 23/09/2010 |
| Date ISRCTN assigned | 23/09/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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