Functional and work outcomes improve in patients with Rheumatoid Arthritis (RA) who receive targeted comprehensive occupational therapy

ISRCTN	ISRCTN36516369
DOI	https://doi.org/10.1186/ISRCTN36516369
Protocol serial number	LREC 05\q0707\50
Sponsor	Guy's and St Thomas' NHS Foundation Trust (UK)
Funder	Guy's and St Thomas' Charity (UK)

Submission date: 08/10/2007
Registration date: 15/10/2007
Last edited: 08/06/2011

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

Dr Bruce Kirkham
Scientific

Guy's Hospital
Rheumatology Department
4th Floor Thomas Guy House
St Thomas Street
London
SE1 9RT
United Kingdom

Phone	+44 207 188 5907
Email	bruce.kirkham@gstt.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised Controlled Trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Purpose: To examine the impact of comprehensive Occupational Therapy (OT) with employed RA patients at risk of work loss. The primary goal was to determine if targeted comprehensive OT intervention improved overall functional status, assessed by the Canadian Occupational Performance Measure (COPM). The secondary goal was to determine if improvements in physical function enhanced productivity, assessed by a combination of absenteeism and presenteeism measures. We hypothesized that improvements in functional status would result in improved work outcomes.
Ethics approval(s)	Bexley and Greenwich Research Ethics Committee, UK. (ref: LREC 05\q0707\50)
Health condition(s) or problem(s) studied	Rheumatoid Arthritis (RA)
Intervention	Occupational therapy versus usual care. Comprehensive occupational therapy alongside usual rheumatology care. Typical OT interventions included the following: 1. Provision of education on RA 2. Medications, compliance and management within the IAC 3. Self-advocacy 4. Work place rights and responsibilities 5. Ergonomic reviews 6. Discussions with employers regarding reasonable accommodations 7. Posture and positioning advice 8. Pacing 9. Activities of daily living 10. Stress management 11. Assertiveness 12. Sleep posture and hygiene 13. Exercises 14. Footwear 15. Splinting 16. Assertive communication Patients were referred to multidisciplinary team members and community services as required. Duration of intervention: 6 months
Intervention type	Other
Primary outcome measure(s)	The following outcomes were measured at baseline and 6 months: 1. The Canadian Occupational Performance Measure (COPM). The COPM is a well known standardised semi-structured interview tool designed for use by OTs to detect change in a patient's self perception of occupational performance. 2. The Health Assessment Questionnaire Disability Index (HAQ-DI) is a standardised, self-administered, written questionnaire developed to assess the extent of the patient's functional ability.
Key secondary outcome measure(s)	The following outcomes were measured at baseline and 6 months: 1. The RA-Work Instability Scale (RA-WIS) is a self administered written validated questionnaire used to screen for WD. The questionnaire takes less than 5 minutes to complete by checking 'yes' or 'no' boxes in a series of 23 questions. 2. The Modified Health Economics Questionnaire combined measures of presenteeism and absenteeism. This is a written self-report questionnaire which includes the following: a. Number of days/hours at work per week b. Number of days missed from work in the past month due to RA c. A 100 mm Visual Analogue Scale (VAS) for work performance and work satisfaction affected by RA, in the past week
Completion date	26/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	34
Key inclusion criteria	Employed RA patients were recruited at the Inflammatory Arthritis Centres (IACs), Guy's and St. Thomas' NHS Foundation Trust, to ensure standardised medical management. Within the IACs the focus of medical treatment is on early, aggressive management with a goal of achievement of remission (the Disease Activity Score 28-joint assessment [DAS28] <2.6). Participants were eligible if they: 1. Had a confirmed diagnosis of RA 2. Were involved in full time/part-time work or were self employed 3. Were fluent in English 4. Lived locally 5. Had medium or high Work Disability (WD) risk on the RA-Work Instability Scale (RA-WIS)
Key exclusion criteria	1. Participating in another trial 2. Other major co-morbidities (e.g. cancer, fibromyalgia) 3. Pending major surgery/retirement in the next year 4. Had received OT intervention within the past 18 months
Date of first enrolment	01/10/2005
Date of final enrolment	26/06/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Guy's Hospital

London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	15/11/2009		Yes	No