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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03345186

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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	Phase
Gout Arthritis Crystal Arthropathy	Other: nurse led plus standard of care	N/A

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

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Interventional group: structured nurse led patient management programm & sc Control group standard of care (sc) aloneInterventional 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

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

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

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

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Basel	Basel-Stadt	Switzerland	4030

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Thomas Daikeler, Prof. Dr. med., University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT03345186

Other Study ID Numbers:

Rheuma_gout_11_17

First Posted:

Nov 17, 2017

Last Update Posted:

Nov 4, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Basel, Switzerland

Outcome

Gout

Additional relevant MeSH terms:

Gout

Crystal Arthropathies

Study Results

No Results Posted as of Nov 4, 2021