A Nurse Led Patient Management Programme to Improve Outcomes in Gout

Not Applicable

Completed

• Conditions: Gout; Crystal Arthropathy; Arthritis
• Interventions: Other: nurse led plus standard of care

• Registration Number: NCT03345186
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-17
• Study Start: 2019-04-01
• Primary Completion: 2021-10-25
• Study Completion: 2022-04-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse led plus standard of care	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

Primary Outcome Measures

Name	Time	Method
Serum uric acid level at 6 months Follow-up	6 months	percentage of patients who reach the SUA target level of 360 umol/l

Secondary Outcome Measures

Name	Time	Method
Longterm achievement of the target SUA at 12 months	12 months	percentage of patients who reach the SUA target level of 360 umol/l

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, Basel-Stadt, Switzerland