Condition category
Musculoskeletal Diseases
Date applied
20/09/2012
Date assigned
21/09/2012
Last edited
11/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

11/EN/0103

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2011

Overall trial end date

31/10/2011

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

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

Location

United Kingdom

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

11/04/2016: No publications found, verifying study status with principal investigator