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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	21 November 2022
Main ID:	ISRCTN42355303
Date of registration:	23/01/2004
Prospective Registration:	No
Primary sponsor:	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Public title:	A controlled trial of shared care for chronic rheumatoid arthritis
Scientific title:	A controlled trial of shared care for chronic rheumatoid arthritis
Date of first enrolment:	01/04/1995
Target sample size:	209
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN42355303
Study type:	Interventional
Study design:	Randomised controlled trial (Treatment)
Phase:	Not Specified

Countries of recruitment
England	United Kingdom

Contacts

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

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Consecutive patients with established rheumatoid arthritis according to standard criteria attending a follow up outpatient clinic.
Exclusion criteria: Does not comply with above inclusion criteria.

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
Musculoskeletal Diseases
Rheumatoid arthritis

Intervention(s)

1. Shared care
2. Standard hospital care

Primary Outcome(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

Secondary Outcome(s)

Not provided at time of registration.

Secondary ID(s)

PSI13-13

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	05/07/1999
URL:

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