Study Results
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-10-01
2027-08-01
Brief Summary
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Eligible patients will be recruited from five rheumatology departments in the Central Denmark Region after achieving two consecutive target serum urate levels-below 0.36 mmol/L, or below 0.30 mmol/L for patients with tophi.
Participants will be adults with gout who meet specific medical criteria, are taking medications such as allopurinol or Adenuric, and are able to read and write Danish.
Participants will be randomly assigned to one of two groups:
* Intervention group: nurse-led telehealth support.
* Control group: usual care with follow-up by their general practitioner.
The primary goal is to support patients in maintaining healthy uric acid levels after 52 weeks.
Participants in the nurse-led group have the option to choose from four support options:
I1: App-Based Support - an app provides information and reminders. I2: Letter Reminders - messages are sent via digital or postal mail. I3: Text Reminders - SMS messages are sent every three months. I4: Phone Support - nurses call three times a year to check in.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Nurse-led self-management support
Nurse-Led Self-Management Support
The intervention offers four distinct support options. Patients are free to choose the option that best suits their preferences and needs.
I1: App-Based Monitoring - Patients receive an app that provides relevant health information, including short educational videos, images, and other resources. Every three months, the app sends a pop-up reminder.
I2: Reminder by Letter - Patients receive a friendly reminder every three months via e-Boks or postal mail (for those without e-Boks access) encouraging continued treatment adherence.
I3: SMS Reminder - Patients receive a text message every three months to remind them to continue their treatment.
I4: Phone Call Check-In - A nurse contacts the patient by phone three times per year at scheduled intervals to provide support and ensure they remain on track with their treatment.
GP-follow up
GP-follow up
Patients in the control group will be discharged from the hospital and continue with routine care provided by their general practitioner (GP). The GP will receive a discharge letter outlining the recommended treatment plan. In addition, patients will receive a letter containing key information about their condition, along with a recommendation to consult their GP annually for ongoing disease monitoring.
Interventions
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Nurse-Led Self-Management Support
The intervention offers four distinct support options. Patients are free to choose the option that best suits their preferences and needs.
I1: App-Based Monitoring - Patients receive an app that provides relevant health information, including short educational videos, images, and other resources. Every three months, the app sends a pop-up reminder.
I2: Reminder by Letter - Patients receive a friendly reminder every three months via e-Boks or postal mail (for those without e-Boks access) encouraging continued treatment adherence.
I3: SMS Reminder - Patients receive a text message every three months to remind them to continue their treatment.
I4: Phone Call Check-In - A nurse contacts the patient by phone three times per year at scheduled intervals to provide support and ensure they remain on track with their treatment.
GP-follow up
Patients in the control group will be discharged from the hospital and continue with routine care provided by their general practitioner (GP). The GP will receive a discharge letter outlining the recommended treatment plan. In addition, patients will receive a letter containing key information about their condition, along with a recommendation to consult their GP annually for ongoing disease monitoring.
Eligibility Criteria
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Inclusion Criteria
* Fulfills ACR/EULAR 2015 Gout Classification Criteria
* Estimated Glomerular Filtration Rate (e-GFR) \>30 ml/min
* Prescribed Allopurinol or Adenuric, and achieved two consecutive serum urate levels of two consecutive serum urate levels of ≤0.30 mmol/l for patients with tophi and ≤0.36 mmol/L for patients without tophi
* Have sufficient Danish reading and writing skills to understand information and complete questionnaires.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Regionshospitalet Silkeborg
OTHER
Gødstrup Hospital
OTHER
Randers Regional Hospital
OTHER
Regionshospitalet Horsens
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Aarhus University Hospital
Aarhus, , Denmark
Gødstrup Hospital
Herning, , Denmark
Horsens Hospital
Horsens, , Denmark
Randers Hospital
Randers, , Denmark
Silkeborg Hospital
Silkeborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2096-00035B
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1-10-72-165-24
Identifier Type: -
Identifier Source: org_study_id
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