- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03345186
A Nurse Led Patient Management Programme to Improve Outcomes in Gout (BONUS)
A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basel-Stadt
-
Basel, Basel-Stadt, Switzerland, 4030
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.
|
No Intervention: Standard of care
Standard of care for gout patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum uric acid level at 6 months Follow-up
Time Frame: 6 months
|
percentage of patients who reach the SUA target level of 360 umol/l
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longterm achievement of the target SUA at 12 months
Time Frame: 12 months
|
percentage of patients who reach the SUA target level of 360 umol/l
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thomas Daikeler, Prof. Dr. med., University Hospital, Basel, Switzerland
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rheuma_gout_11_17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis
-
Northumbria Healthcare NHS Foundation TrustUniversity of YorkRecruitingKnee Arthritis | Hip ArthritisUnited Kingdom
-
MedShape, IncOrthopedic Foot and Ankle Center, Ohio; CurveBeam LLCRecruitingAnkle Arthritis | Arthritis FootUnited States
-
Chang Gung Memorial HospitalNot yet recruitingArthritis Knee | Arthritis HipTaiwan
-
MedShape, IncSaint Alphonsus Medical GroupUnknownAnkle Arthritis | Foot ArthritisUnited States
-
MedShape, IncUniversity of Alabama at BirminghamRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
University of Alabama at BirminghamMedShape, IncRecruiting
-
MedShape, IncThe University of Texas Medical Branch, GalvestonRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
Saint Alphonsus Regional Medical CenterCompletedArthritis Knee | Arthritis of HipUnited States
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedJuvenile Idiopathic Arthritis | Arthritis, Septic | Arthritis, UnspecifiedFrance
Clinical Trials on nurse led plus standard of care
-
University of Texas Southwestern Medical CenterCompletedMultidisciplinary CommunicationUnited States
-
Radboud University Medical CenterCompleted
-
Kathmandu University School of Medical SciencesUnknownDiabetes Mellitus, Type 2
-
The Hong Kong Polytechnic UniversityCompletedBreast Neoplasms | Colorectal NeoplasmsChina
-
Izmir Bakircay UniversityCompleted
-
Izmir Bakircay UniversityCompletedNurse-led Supportive CareTurkey
-
Umeå UniversityRecruiting
-
University of BaselKU Leuven; University Hospital Inselspital, Berne; Swiss National Science Foundation and other collaboratorsCompleted
-
Michelle ColeTerminatedFocus of Study: The Safety of an Online Pre-assessment Tool
-
Izmir Bakircay UniversityRecruitingNurse-led Supportive CareTurkey