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
Secondary identifying numbers LREC 05\q0707\50
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

Study designRandomised Controlled Trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesPurpose: 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) studiedRheumatoid Arthritis (RA)
InterventionOccupational 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 typeOther
Primary outcome measureThe 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.
Secondary outcome measuresThe 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
Overall study start date01/10/2005
Completion date26/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants34
Key inclusion criteriaEmployed 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 criteria1. 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 enrolment01/10/2005
Date of final enrolment26/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Guy's Hospital
London
SE1 9RT
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

Guy's Hospital
R&D Office
Ground Floor
West Wing
Counting House
St. Thomas Street
London
SE1 9RT
England
United Kingdom

Phone +44 207 188 5733
Email kate.blake@gstt.nhs.uk
Website http://www.guysandstthomas.nhs.uk/
ROR logo "ROR" https://ror.org/00j161312

Funders

Funder type

Charity

Guy's and St Thomas' Charity (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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