A Nurse Led Patient Management Programme to Improve Outcomes in Gout
NCT ID: NCT03345186
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2019-04-01
2022-04-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Nurse led plus standard of care
Nurse Led Patient Management Programme to Improve Outcomes in Gout and Standard of care for gout patients, including nurse delivered patient education and follow up
nurse led plus standard of care
structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.
Standard of care
Standard of care for gout patients
No interventions assigned to this group
Interventions
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nurse led plus standard of care
structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Thomas Daikeler, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital
Basel, Canton of Basel-City, Switzerland
Countries
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References
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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.
Other Identifiers
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Rheuma_gout_11_17
Identifier Type: -
Identifier Source: org_study_id
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