A controlled trial of shared care for chronic rheumatoid arthritis

ISRCTN	ISRCTN42355303
DOI	https://doi.org/10.1186/ISRCTN42355303
Secondary identifying numbers	PSI13-13

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	01/04/1995
Completion date	05/07/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

England
United Kingdom

Study participating centre

Rheumatology Unit

Bristol
BS2 8HW
United Kingdom

Sponsor information

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

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

Website	http://www.doh.gov.uk

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
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	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.