A Nurse Led Patient Management Programme to Improve Outcomes in Gout

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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Crystal Arthropathy Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Basel, Canton of Basel-City, 4030, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nurse led plus standard of care

Other

structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: BONUS

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: Nov 17, 2017
Registry last updated: May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed