A comparison of patient outcome from a rheumatology nurse practitioner clinic compared to standard outpatient care

ISRCTN	ISRCTN65487167
DOI	https://doi.org/10.1186/ISRCTN65487167
Protocol serial number	H0576
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (ARC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Jackie Hill
Scientific

CPU (Rheumatism Research)
University of Leeds
Chapel Allerton Hospital
Harehills Lane
Leeds
LS7 4SA
United Kingdom

Phone	+44 (0)113 262 3404
Email	j.hill@leeds.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A comparison of patient outcome from a rheumatology nurse practitioner clinic compared to standard outpatient care: a randomised controlled trial
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	Any patient over 18 years of age with a positive diagnosis of rheumatoid arthritis or osteoarthritis
Key exclusion criteria	Does not comply with inclusion criteria
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2004

CPU (Rheumatism Research)

Leeds
LS7 4SA
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No