Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial
| Registry | NCT06971146, acronym GoutConnect |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, health services research |
| Enrollment | 200 (Estimated) |
| Sponsor | University of Aarhus (Other); collaborators: Aarhus University Hospital, Regionshospitalet Silkeborg, Gødstrup Hospital, Randers Regional Hospital, Regionshospitalet Horsens |
| Conditions | Health Literacy, Gout Arthritis, Gout Initiating Urate-loweringUrate-lowering Therapy, Telehealth, Digital Health, Adherence |
| Interventions | Nurse-Led Self-Management Support, GP-follow up (Other) |
| Dates | start 2025-10-01 (estimated), primary completion 2027-08-01 (estimated), completion 2027-08-01 (estimated), first posted 2025-05-14, last updated 2025-09-18 |
| Locations | 5 sites in Denmark |
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All trials for Health Literacy All trials for Gout Arthritis All trials of Nurse-Led Self-Management Support All trials of GP-follow up
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Nurse-led self-management support | Experimental | Other: Nurse-Led Self-Management Support | |
| GP-follow up | Active comparator | Other: GP-follow up |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |