GoutBONUSNCT03345186
A Nurse Led Patient Management Programme to Improve Outcomes in Gout
A study of Gout and Arthritis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout, Arthritis, Crystal Arthropathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2019to 23 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gout, Arthritis, Crystal Arthropathy
- Being tested
- nurse led plus standard of care
- Keywords
- Outcome, Gout
- Medical subject headings
- Gout, Arthritis, Crystal Arthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse led plus standard of careOther
structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.
| Study group | Role | What they receive |
|---|---|---|
| Nurse led plus standard of care | Experimental | 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 Receives: Other: nurse led plus standard of care |
| Standard of care | No intervention | Standard of care for gout patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid level at 6 months Follow-up
percentage of patients who reach the SUA target level of 360 umol/l
Measured: 6 months
Secondary outcomes (1)
Longterm achievement of the target SUA at 12 months
percentage of patients who reach the SUA target level of 360 umol/l
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Apr 2019
- Primary completion25 Oct 2021
- Study completion23 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional group: structured nurse led patient management programm \& sc Control group standard of care (sc) alone
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Daikeler, Prof. Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345186
- Sponsor's protocol ID
- Rheuma_gout_11_17
- Acronym
- BONUS
- Status last verified
- May 2024
- First submitted
- 13 Nov 2017
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26352873
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured Nurse Led Patient Management Programme to Improve Outcomes in Gout: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03345186
- Acronym / sponsor ID
- BONUS / Rheuma_gout_11_17
- Conditions
- Gout, Arthritis, Crystal Arthropathy
- Keywords
- Outcome, Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional group: structured nurse led patient management programm \& sc Control group standard of care (sc) alone
| Arm | Type | Receives |
|---|---|---|
| Nurse led plus standard of care | Experimental | Other: nurse led plus standard of careNurse 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 | No intervention | –Standard of care for gout patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse led plus standard of carestructured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done. | Other | Nurse led plus standard of care |
Primary outcome
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
1 secondary outcome
Longterm achievement of the target SUA at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Results publication: PubMed 26352873Neogi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Daikeler, Prof. Dr. med. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gout and Arthritis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum uric acid level at 6 months Follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.