Condition category
Circulatory System
Date applied
26/08/2010
Date assigned
23/09/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.clahrc-ndl.nihr.ac.uk/our-themes/clinical-themes/stroke-rehabilitation/return-to-work-after-stroke_20

Contact information

Type

Scientific

Primary contact

Dr Kate Radford

ORCID ID

Contact details

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

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 measures

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

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

http://www.nottingham.ac.uk/ris/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes