Clinical trial NCT03345186: A Nurse Led Patient Management Programme to Improve Outcomes in Gout
Official title: A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gout
Arthritis
Crystal Arthropathy
Keywords: Outcome
Gout
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional group: structured nurse led patient management programm \& sc Control group standard of care (sc) alone
Primary purpose: OTHER

Brief summary: This study evaluates the addition of a structured nurse led patient management programme to standard of care in gout patients. Half of the patient will receive the nurse led programme in addition to standard of care and the other half will receive standard of care only.

Detailed description: There is evidence from other chronic diseases that nurse led care in addition to standard of care ameliorates outcomes.

In gout the primary target is the serum uric acid level (SUA). We intend to demonstrate the superiority of a structured nurse led patient management programme over standard of care in a randomized controlled study.

The primary endpoint is the percentage of patients reaching the target SUA level at 6 months follow-up.

Eligibility criteria: Inclusion Criteria:

* Proven diagnosis of gout according to aspiration of Monosodium urate (MSU) crystals or positive dual energy computer tomography (DECT) or American college of rheumatology (ACR) criteria 2015 fulfilled (1)
* written informed consent
* age \>=18 years
* ability and willingness to follow a fixed outpatient programme as judged by the investigator
* indication for urate-lowering therapy (ULT)
* In case of established disease and intercritical gout a SUA level over 360 umol per liter is mandatory.

Exclusion Criteria:

* informed consent not obtained
* age \<18 years
* inability or unwillingness to follow a fixed outpatient programme as judged by the investigator
* no definite diagnosis of Gout
* no indication for ULT or contraindications against ULT
* in case of established disease and intercritical gout a SUA level \<360 umol per liter is an exclusion criterion
* Pregnant or breastfeeding women can´t participate.

Primary outcomes:
measure: Serum uric acid level at 6 months Follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Longterm achievement of the target SUA at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Thomas Daikeler, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neogi T, Jansen TL, Dalbeth N, Fransen J, Schumacher HR, Berendsen D, Brown M, Choi H, Edwards NL, Janssens HJ, Liote F, Naden RP, Nuki G, Ogdie A, Perez-Ruiz F, Saag K, Singh JA, Sundy JS, Tausche AK, Vazquez-Mellado J, Yarows SA, Taylor WJ. 2015 Gout Classification Criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheumatol. 2015 Oct;67(10):2557-68. doi: 10.1002/art.39254.