Contact information
Type
Scientific
Primary contact
Dr Bruce Kirkham
ORCID ID
Contact details
Guy's Hospital
Rheumatology Department
4th Floor Thomas Guy House
St Thomas Street
London
SE1 9RT
United Kingdom
+44 207 188 5907
bruce.kirkham@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LREC 05\q0707\50
Study information
Scientific title
Acronym
Study hypothesis
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
Bexley and Greenwich Research Ethics Committee, UK. (ref: LREC 05\q0707\50)
Study design
Randomised Controlled Trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/10/2005
Overall trial end date
26/06/2007
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
34
Participant 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
Recruitment start date
01/10/2005
Recruitment end date
26/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
Guy's Hospital
R&D Office
Ground Floor
West Wing
Counting House
St. Thomas Street
London
SE1 9RT
United Kingdom
+44 207 188 5733
kate.blake@gstt.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Guy's and St Thomas' Charity (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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19877106
Publication citations
-
Results
Macedo AM, Oakley SP, Panayi GS, Kirkham BW, Functional and work outcomes improve in patients with rheumatoid arthritis who receive targeted, comprehensive occupational therapy., Arthritis Rheum., 2009, 61, 11, 1522-1530, doi: 10.1002/art.24563.