A Nurse Led Patient Management Programme to Improve Outcomes in Gout

Arthritis Clinical Trial

— BONUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345186
• Other study ID #: Rheuma_gout_11_17
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 23, 2022

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 23, 2022
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Crystal Arthropathy
• Gout

Intervention

Other:
• nurse led plus standard of care
structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Neogi T, Jansen TL, Dalbeth N, Fransen J, Schumacher HR, Berendsen D, Brown M, Choi H, Edwards NL, Janssens HJ, Liote F, Naden RP, Nuki G, Ogdie A, Perez-Ruiz F, Saag K, Singh JA, Sundy JS, Tausche AK, Vazquez-Mellado J, Yarows SA, Taylor WJ. 2015 Gout Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Longterm achievement of the target SUA at 12 months	percentage of patients who reach the SUA target level of 360 umol/l	12 months