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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):

November 13, 2017
November 17, 2017
November 17, 2017
January 2018
January 2020   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
A Nurse Led Patient Management Programme to Improve Outcomes in Gout
A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial
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.

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.

Interventional
Not Provided
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
  • Gout
  • Arthritis
  • Crystal Arthropathy
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.
  • 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
    Intervention: Other: nurse led plus standard of care
  • No Intervention: Standard of care
    Standard of care for gout patients
Neogi T, Jansen TL, Dalbeth N, Fransen J, Schumacher HR, Berendsen D, Brown M, Choi H, Edwards NL, Janssens HJ, Lioté 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 Classification Criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheumatol. 2015 Oct;67(10):2557-68. doi: 10.1002/art.39254. Erratum in: Arthritis Rheumatol. 2016 Feb;68(2):515. Vaquez-Mellado, Janitzia [corrected to Vazquez-Mellado, Janitzia].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
January 2021
January 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Thomas Daikeler, Assoc. Pr. 0041613286827 thomas.daikeler@usb.ch
Contact: Barbara Ankli, MD 0041612652525 barbara.ankli@usb.ch
Not Provided
 
 
NCT03345186
Rheuma_gout_11_17
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Thomas Daikeler, Assoc. Pr. University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP