A controlled trial of shared care for chronic rheumatoid arthritis

ISRCTN	ISRCTN42355303
DOI	https://doi.org/10.1186/ISRCTN42355303
Protocol serial number	PSI13-13
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 09/11/2022

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 John Kirwan
Scientific

Rheumatology Unit
Bristol Royal Infirmary
University of Bristol Division of Medicine
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 2904
Email	John.Kirwan@Bristol.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A controlled trial of shared care for chronic rheumatoid arthritis
Study objectives	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(s)	Ethics approval recieved from United Bristol Health Care Trust Research Ethics Committee.
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	1. Shared care 2. Standard hospital care
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	05/07/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	209
Total final enrolment	209
Key inclusion criteria	Consecutive patients with established rheumatoid arthritis according to standard criteria attending a follow up outpatient clinic.
Key exclusion criteria	Does not comply with above inclusion criteria.
Date of first enrolment	01/04/1995
Date of final enrolment	05/07/1999

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Rheumatology Unit

Bristol
BS2 8HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Date created	Peer reviewed?	Patient-facing?
Results article	01/09/2000	Yes	No
Results article	01/03/2003	Yes	No
Results article	22/01/2005	Yes	No

Editorial Notes

09/11/2022: Total final enrolment added.