Work Rehabilitation in Inflammatory Arthritis - Effectiveness and cost effectiveness of an occupational therapy (OT) job retention intervention: a pilot randomised controlled trial

ISRCTN	ISRCTN76777720
DOI	https://doi.org/10.1186/ISRCTN76777720
Secondary identifying numbers	10521

Submission date: 20/09/2012
Registration date: 21/09/2012
Last edited: 15/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alison Hammond
Scientific

Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
United Kingdom

Email	a.hammond@salford.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Work Rehabilitation in Inflammatory Arthritis - Effectiveness and cost effectiveness of an occupational therapy (OT) job retention intervention: a pilot randomised controlled trial
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	31/10/2011

Eligibility

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)
Key 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
Key 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
Date of first enrolment	01/10/2011
Date of final enrolment	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

University of Salford (UK)
University/education

Centre for Rehabilitation and Human Performance Research
Allerton Building
Frederick Road
Salford
M6 6PU
England
United Kingdom

"ROR"	https://ror.org/01tmqtf75

Funders

Funder type

Charity

Arthritis Research UK (UK)
Private sector organisation / Other non-profit organizations

Location: United Kingdom

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

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

Editorial Notes

15/05/2020: Publication references added.
25/07/2017: Publication reference added.