A Nurse Led Patient Management Programme to Improve Outcomes in Gout

NCT ID: NCT03345186

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-04-23

Brief Summary

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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

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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.

Conditions

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Gout Arthritis Crystal Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional group: structured nurse led patient management programm \& sc Control group standard of care (sc) alone
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

nurse led plus standard of care

Intervention Type OTHER

structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.

Standard of care

Standard of care for gout patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Daikeler, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 26352873 (View on PubMed)

Other Identifiers

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Rheuma_gout_11_17

Identifier Type: -

Identifier Source: org_study_id

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