Contact information
Type
Scientific
Contact name
Prof Alison Hammond
ORCID ID
Contact details
Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
United Kingdom
-
a.hammond@salford.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
10521
Study information
Scientific title
Work Rehabilitation in Inflammatory Arthritis - Effectiveness and cost effectiveness of an occupational therapy (OT) job retention intervention: a pilot randomised controlled trial
Acronym
Study hypothesis
This is a feasibility study for a future randomised controlled trial evaluating the effectiveness of a vocational rehabilitation (VR) intervention provided by occupational therapists for employed people with inflammatory arthropathies (n=100). Patients are being recruited from 6 Rheumatology departments in England.
The study aims to identify the most appropriate primary work outcome measure and feasibility of recruitment procedures, VR provision and questionnaire completion. Participants, employers (following patient consent), therapists and therapy managers will also be interviewed to identify their views of the feasibility of the intervention.
Ethics approval(s)
11/EN/0103
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
Participants are randomly allocated to receive VR or a stay at work information pack only.
Control group: An information pack including the National Rheumatoid Arthritis Society and Arthritis Care publications about Working with Arthritis
Vocational Rehabilitation: Up to x 1.5 hour appointments with an occupational therapist, trained in deliver:
1. Applying ergonomic, fatigue and stress management approaches to the workplace
2. Recommendations for assistive technology/equipment adaptation, workplace/work station modification, transport advice
3. Practical advice and support to enable participants to disclose their condition and negotiate job modifications with employers
4. Explaining rights under the Equality Act 2010 and the facilities available to
Follow Up Length: 9 month(s)
Intervention type
Other
Primary outcome measure
1. Work status
1.1. Work instability
1.2. Sickness absence
Measured at 0, 6 and 9 months
Secondary outcome measures
1. Health status
1.1. Pain
1.2. Fatigue
1.3. Functional status
2. NHS costs
Measured at 0, 6, 9 months
Overall study start date
01/10/2011
Overall study end date
31/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. People with inflammatory arthritis (i.e., specifically early inflammatory arthritis [IA], rheumatoid arthritis [RA], psoriatic arthritis [PA])
2. Aged 18 years and over
3. Able to read, write and understand English and in paid work (full or parttime)
4. People who answer "yes" to:"Do you have any concerns about your health affecting your ability to work over the next few years?"
5. Able to give informed consent
6. Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100; Description: People with inflammatory arthritis (i.e. specifically early inflammatory arthritis (IA), rheumatoid arthritis (RA), psoriatic arthritis (PA)
Participant exclusion criteria
People who are:
1. On extended sick leave (i.e. > 3 months) or unemployed (including not normally in paid employment or student)
2. Planning to retire or take early retirement (through choice or ill health) within the next 12 months
3. Already receiving or awaiting work rehabilitation services
4. Planning to move out of area or expecting joint replacement surgery in the next 6 months
5. Other conditions affecting work apart from arthritis (e.g. uncontrolled medical/ psychiatric problems
Recruitment start date
01/10/2011
Recruitment end date
31/10/2011
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Centre for Rehabilitation and Human Performance Research
Salford
M6 6PU
United Kingdom
Sponsor information
Organisation
University of Salford (UK)
Sponsor details
Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Arthritis Research UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/07/2017 | Yes | No | |
| Results article | qualitative results with participants | 01/01/2017 | 15/05/2020 | Yes | No |
| Results article | qualitative results with therapists | 01/08/2015 | 15/05/2020 | Yes | No |
| Results article | therapist work rehabilitation training results | 01/06/2013 | 15/05/2020 | Yes | No |