Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
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 John Kirwan

ORCID ID

Contact details

Rheumatology Unit
Bristol Royal Infirmary
University of Bristol Division of Medicine
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 2904
John.Kirwan@Bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI13-13

Study information

Scientific title

Acronym

Study hypothesis

To determine whether, in an open access system of shared care of patients with established rheumatoid arthritis who have open access to hospital review, there will be:
1. An improvement in the clinical and psychological outcome
2. A reduction in the use of health care resources
3. A preference for shared care over routine care

Ethics approval

Ethics approval recieved from United Bristol Health Care Trust Research Ethics Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

1. Shared care
2. Standard hospital care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Clinical and psychological status:
1.1. Pain
1.2. Disease activity
1.3. Disability
1.4. Grip strength
1.5. Range of movement
1.6. Articular index
1.7. Plasma viscosity
1.8. Serum C-reactive protein
1.9. Haemoglobin and hand x-ray
1.10. Helplessness
1.11. Anxiety
1.12. Depression
1.13. Self efficacy
1.14. Changes in medication
1.15. Days lost from work
2. Resource measures:
2.1. Visits to health professionals
2.2. Use of transport
3. Satisfaction measures: patient and GP satisfaction with and confidence in the system of care
4. Safety net monitoring: a blind assessor reviewed three-monthly questionnaires to provide a 'safety net' against deterioration while not attending follow-up

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/04/1995

Overall trial end date

05/07/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive patients with established rheumatoid arthritis according to standard criteria attending a follow up outpatient clinic.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

209

Participant exclusion criteria

Does not comply with above inclusion criteria.

Recruitment start date

01/04/1995

Recruitment end date

05/07/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology Unit
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/10986304 (trial over two years)
2. http://www.ncbi.nlm.nih.gov/pubmed/12626791 (follow-up extended to 4 years)
3. http://www.ncbi.nlm.nih.gov/pubmed/15546895 (follow-up extended to 6 years)

Publication citations

  1. Hewlett S, Mitchell K, Haynes J, Paine T, Korendowych E, Kirwan JR, Patient-initiated hospital follow-up for rheumatoid arthritis., Rheumatology (Oxford), 2000, 39, 9, 990-997.

  2. Kirwan JR, Mitchell K, Hewlett S, Hehir M, Pollock J, Memel D, Bennett B, Clinical and psychological outcome from a randomized controlled trial of patient-initiated direct-access hospital follow-up for rheumatoid arthritis extended to 4 years., Rheumatology (Oxford), 2003, 42, 3, 422-426.

  3. Hewlett S, Kirwan J, Pollock J, Mitchell K, Hehir M, Blair PS, Memel D, Perry MG, Patient initiated outpatient follow up in rheumatoid arthritis: six year randomised controlled trial., BMJ, 2005, 330, 7484, 171, doi: 10.1136/bmj.38265.493773.8F.

Additional files

Editorial Notes