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| Functional and work outcomes improve in patients with Rheumatoid Arthritis (RA) who receive targeted comprehensive occupational therapy |
| Source of record | UK Trials |
| ISRCTN | ISRCTN36516369 |
| Date ISRCTN assigned | 15/10/2007 |
| Local reference number(s) | LREC 05\q0707\50 |
| Public title | Functional and work outcomes improve in patients with Rheumatoid Arthritis (RA) who receive targeted comprehensive occupational therapy |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Rheumatoid Arthritis (RA) |
| 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. |
| Design/methodology | Randomised Controlled Trial |
| Research ethics review | Ethical approval was obtained from the Bexley and Greenwich Research Ethics Committee, UK. (ref: LREC 05\q0707\50) |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/10/2005 |
| Anticipated end date | 26/06/2007 |
| Status of trial | Completed |
| Target number of participants | 34 |
| Interventions | 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 |
| 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. |
| 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 |
| Sources of funding | Guy's and St Thomas' Charity (UK) |
| Sponsor name | 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 United Kingdom SE1 9RT |
| Sponsor telephone | +44 207 188 5733 |
| Sponsor email | kate.blake@gstt.nhs.uk |
| Sponsor website | http://www.guysandstthomas.nhs.uk/ |
| Contact name | Dr Bruce Kirkham |
| Contact details | Guy's Hospital Rheumatology Department 4th Floor Thomas Guy House St Thomas Street London United Kingdom SE1 9RT |
| Contact telephone | +44 207 188 5907 |
| Contact email | bruce.kirkham@gstt.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN36516369 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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