| NCT ID | NCT06971146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Health Literacy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-10-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this clinical trial is to evaluate whether nurse-led telehealth support helps individuals with gout better manage their condition and adhere to urate-lowering medication after discharge from a rheumatology clinic. 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.
Eligibility Criteria
Inclusion Criteria: * ≥18 years old * 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: • Cognitively impaired, unable to understand or provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06971146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Health Literacy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06971146 currently recruiting?
Yes, NCT06971146 is actively recruiting participants. Contact the research team at annethur@rm.dk for enrollment information.
Where is the NCT06971146 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herning, Denmark, Horsens, Denmark, Randers, Denmark and 1 additional location.
Who is sponsoring the NCT06971146 clinical trial?
NCT06971146 is sponsored by University of Aarhus. The trial plans to enroll 200 participants.