Contact information
Type
Scientific
Primary contact
Ms Jackie Hill
ORCID ID
Contact details
CPU (Rheumatism Research)
University of Leeds
Chapel Allerton Hospital
Harehills Lane
Leeds
LS7 4SA
United Kingdom
+44 (0)113 262 3404
j.hill@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
H0576
Study information
Scientific title
A comparison of patient outcome from a rheumatology nurse practitioner clinic compared to standard outpatient care: a randomised controlled trial
Acronym
Study hypothesis
Added 27/03/2009:
To assess whether OA patients attending a clinical nurse specialist (CNS) clinic gain 'additional benefit' compared with those attending a traditional junior hospital doctor (JHD) clinic.
Ethics approval
Not provided at time of registration
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, osteoarthritis
Intervention
Patients were seen by either the physician or the nurse who managed their care for a 12 month period so they received either medical or nursing care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Added 27/03/2009:
1. Non-inferiority of the CNS with respect to clinical outcomes:
1.1. Pain
1.2. Morning stiffness
1.3. Self-efficacy
1.4. Physical function
1.5. Psychological status
2. Superiority of the CNS in terms of patient knowledge and satisfaction
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2004
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Any patient over 18 years of age with a positive diagnosis of rheumatoid arthritis or osteoarthritis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added May 2008: 100
Participant exclusion criteria
Does not comply with inclusion criteria
Recruitment start date
01/01/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CPU (Rheumatism Research)
Leeds
LS7 4SA
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19321512
Publication citations
-
Results
Hill J, Lewis M, Bird H, Do OA patients gain additional benefit from care from a clinical nurse specialist?--a randomized clinical trial., Rheumatology (Oxford), 2009, 48, 6, 658-664, doi: 10.1093/rheumatology/kep049.