A Nurse Led Patient Management Programme to Improve Outcomes in Gout

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial

Conditions
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Arthritis, Crystal Arthropathy, Gout

Intervention / Treatment
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* Other: nurse led plus standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional group: structured nurse led patient management programm & sc Control group standard of care (sc) alone
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse led plus standard of care<br>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 | Other: nurse led plus standard of care<br>* structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.<br>|
| No Intervention: Standard of care<br>Standard of care for gout patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum uric acid level at 6 months Follow-up | 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 | percentage of patients who reach the SUA target level of 360 umol/l | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcome, Gout