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

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ClinicalTrials.gov Identifier: NCT03345186
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Gout Arthritis Crystal Arthropathy Other: nurse led plus standard of care

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Interventional group: structured nurse led patient management programm & sc Control group standard of care (sc) alone
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nurse led plus standard of care
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
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.
No Intervention: Standard of care
Standard of care for gout patients


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345186


Contacts
Contact: Thomas Daikeler, Assoc. Pr. 0041613286827 thomas.daikeler@usb.ch
Contact: Barbara Ankli, MD 0041612652525 barbara.ankli@usb.ch

Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Thomas Daikeler, Assoc. Pr. University Hospital, Basel, Switzerland
More Information

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03345186     History of Changes
Other Study ID Numbers: Rheuma_gout_11_17
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
Outcome
Gout

Additional relevant MeSH terms:
Gout
Joint Diseases
Crystal Arthropathies
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases