Nurse-led telehealth support for people with gout
Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial
NA · University of Aarhus · NCT06971146
This trial will try nurse-led telehealth support to help adults with gout stay on urate-lowering medicine and keep their uric acid at target after leaving a rheumatology clinic.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Locations | 5 sites (Aarhus and 4 other locations) |
| Trial ID | NCT06971146 on ClinicalTrials.gov |
What this trial studies
Adults with gout who have reached two consecutive target serum urate levels are randomly assigned to either nurse-led telehealth self-management support or usual follow-up with their general practitioner. The intervention is delivered remotely from five rheumatology departments in the Central Denmark Region and offers participants a choice among four nurse-led support options. Participants are followed for 52 weeks to compare maintenance of target serum urate and medication adherence between groups. Key eligibility includes ACR/EULAR 2015 gout criteria, eGFR >30 ml/min, current prescription of allopurinol or febuxostat (Adenuric), and Danish literacy.
Who should consider this trial
Good fit: Adults (≥18 years) with gout meeting ACR/EULAR 2015 criteria, eGFR >30 ml/min, prescribed allopurinol or Adenuric, who have achieved two consecutive target serum urate measurements (≤0.36 mmol/L or ≤0.30 mmol/L if tophi) and can read and write Danish are ideal candidates.
Not a fit: Patients who cannot read or write Danish, are cognitively impaired and unable to consent, have eGFR ≤30 ml/min, or are not on urate-lowering therapy are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, the intervention could help patients maintain target serum urate levels and reduce gout flares by improving adherence to urate-lowering therapy.
How similar studies have performed: Prior nurse-led gout management programs and digital adherence interventions have shown improved urate control and medication adherence, but nurse-led telehealth specifically for post-discharge gout care is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus and 4 other locations
- Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
- Gødstrup Hospital — Herning, Denmark (RECRUITING)
- Horsens Hospital — Horsens, Denmark (RECRUITING)
- Randers Hospital — Randers, Denmark (RECRUITING)
- Silkeborg Hospital — Silkeborg, Denmark (RECRUITING)
Study contacts
- Study coordinator: Annette de Thurah, CNS, MPH, PHD
- Email: annethur@rm.dk
- Phone: +4529120722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Health Literacy, Gout Arthritis, Gout Initiating Urate-loweringUrate-lowering Therapy, Telehealth, Digital Health, Adherence, self-managment