Condition category
Musculoskeletal Diseases
Date applied
08/10/2007
Date assigned
15/10/2007
Last edited
08/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.guysandstthomas.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes