A Nurse Led Patient Management Programme to Improve Outcomes in Gout (BONUS)

University Hospital Basel

Status: Completed

Conditions: Arthritis; Crystal Arthropathy; Gout

Treatments: Other: nurse led plus standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT03345186

Rheuma_gout_11_17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Nurse led plus standard of care

Experimental group

Description:

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

Treatment:

Other: nurse led plus standard of care

Standard of care

No Intervention group

Description:

Standard of care for gout patients