A Nurse Led Patient Management Programme to Improve Outcomes in Gout

University Hospital, Basel, Switzerland46 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Gout Arthritis Crystal Arthropathy

Interventions

nurse led plus standard of careOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital

Basel, Canton of Basel-City, Switzerland

Outcomes

Primary Outcomes

Serum uric acid level at 6 months Follow-up

percentage of patients who reach the SUA target level of 360 umol/l

Time frame: 6 months

Secondary Outcomes

Longterm achievement of the target SUA at 12 months

percentage of patients who reach the SUA target level of 360 umol/l

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.