Arthritis, Crystal Arthropathy, Gout
Conditions
Keywords
Outcome, Gout
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.
Interventions
OTHERnurse 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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Interventional group: structured nurse led patient management programm & sc Control group standard of care (sc) alone
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Longterm achievement of the target SUA at 12 months | 12 months | percentage of patients who reach the SUA target level of 360 umol/l |
Countries
Switzerland
Outcome results
None listed