Nurse-Led Telehealth for Gout
GoutConnect
Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial
2 other identifiers
interventional
200
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
September 18, 2025
September 1, 2025
1.8 years
May 6, 2025
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of participants achieving target serum urate (s-urate) concentration
The number and proportion of participants with a serum urate concentration equal to or less than 0.36 mmol/L or 0.30 mmol/L if tophi, at 52 weeks after randomization.
52 weeks
Gout impact
Changes in Gout Impact Scale (GIS). GIS is a patient-reported outcome measure assessing the impact of gout on health-related quality of life. The GIS includes domains such as gout concern overall, gout medication side effects, unmet treatment need, well-being during gout attack, and concern during gout attack. Each domain is scored on a 0-100 scale, with higher scores indicating greater impact (worse health status). Change from baseline to week 52 will be calculated, with negative change scores indicating improvement (i.e., reduced gout impact).
52 weeks
Secondary Outcomes (2)
Quality of life one year after discharge from a rheumatology clinic indicated by EQ-5D-5L.
52 weeks
Proportion of participants adherent to urate lowering drugs based on CQR-5
52 weeks
Other Outcomes (6)
Need for acute healthcare visits
52 weeks
All contacts to the rheumatology department
52 weeks
Change in Gout-related Global Assessment (PGA) score
52 weeks
- +3 more other outcomes
Study Arms (2)
Nurse-led self-management support
EXPERIMENTALGP-follow up
ACTIVE COMPARATORInterventions
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.
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
You may qualify if:
- ≥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.
You may not qualify if:
- Cognitively impaired, unable to understand or provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Regionshospitalet Silkeborgcollaborator
- Gødstrup Hospitalcollaborator
- Randers Regional Hospitalcollaborator
- Regionshospitalet Horsenscollaborator
Study Sites (5)
Aarhus University Hospital
Aarhus, 8200, Denmark
Gødstrup Hospital
Herning, 7400, Denmark
Horsens Hospital
Horsens, 8700, Denmark
Randers Hospital
Randers, 8930, Denmark
Silkeborg Hospital
Silkeborg, 8600, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share