Functional and work outcomes improve in patients with Rheumatoid Arthritis (RA) who receive targeted comprehensive occupational therapy
ISRCTN | ISRCTN36516369 |
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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
Scientific
Guy's Hospital
Rheumatology Department
4th Floor Thomas Guy House
St Thomas Street
London
SE1 9RT
United Kingdom
Phone | +44 207 188 5907 |
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bruce.kirkham@gstt.nhs.uk |
Study information
Study design | Randomised Controlled Trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | 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 study start date | 01/10/2005 |
Completion date | 26/06/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
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 |
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kate.blake@gstt.nhs.uk | |
Website | http://www.guysandstthomas.nhs.uk/ |
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)
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 | |
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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? |
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Results article | results | 15/11/2009 | Yes | No |