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
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
-
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.
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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.
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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.