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

Primary Purpose

Gout, Arthritis, Crystal Arthropathy

Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
nurse led plus standard of care
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gout focused on measuring Outcome, Gout

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nurse led plus standard of care

Standard of care

Arm Description

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

Standard of care for gout patients

Outcomes

Primary Outcome Measures

Serum uric acid level at 6 months Follow-up
percentage of patients who reach the SUA target level of 360 umol/l

Secondary Outcome Measures

Longterm achievement of the target SUA at 12 months
percentage of patients who reach the SUA target level of 360 umol/l

Full Information

First Posted
November 13, 2017
Last Updated
November 3, 2021
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03345186
Brief Title
A Nurse Led Patient Management Programme to Improve Outcomes in Gout
Acronym
BONUS
Official Title
A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Arthritis, Crystal Arthropathy
Keywords
Outcome, Gout

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional group: structured nurse led patient management programm & sc Control group standard of care (sc) alone
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse led plus standard of care
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care for gout patients
Intervention Type
Other
Intervention Name(s)
nurse led plus standard of care
Intervention Description
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 Outcome Measure Information:
Title
Serum uric acid level at 6 months Follow-up
Description
percentage of patients who reach the SUA target level of 360 umol/l
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Longterm achievement of the target SUA at 12 months
Description
percentage of patients who reach the SUA target level of 360 umol/l
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Daikeler, Prof. Dr. med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4030
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26352873
Citation
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 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].
Results Reference
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A Nurse Led Patient Management Programme to Improve Outcomes in Gout

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