Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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.

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Gødstrup Hospital
RECRUITING
Herning
Horsens Hospital
RECRUITING
Horsens
Randers Hospital
RECRUITING
Randers
Silkeborg Hospital
RECRUITING
Silkeborg
Contact Information
Primary
Annette de Thurah, CNS, MPH, PHD
annethur@rm.dk
+4529120722
Backup
Sofie B Vestergaard, RN, MSc, PhD-fellow
sofive@rm.dk
+4523425312
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 200
Treatments
Experimental: Nurse-led self-management support
Active_comparator: GP-follow up
Related Therapeutic Areas
Sponsors
Collaborators: Regionshospitalet Horsens, Gødstrup Hospital, Randers Regional Hospital, Regionshospitalet Silkeborg, Aarhus University Hospital
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov