Nurse-Led Telehealth for Gout
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurse-Led Self-Management Support, GP-follow up.
- Who it may be relevant to
- Registry conditions: Health Literacy, Gout Arthritis, Gout Initiating Urate-loweringUrate-lowering Therapy, Telehealth. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial
Overview
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.
Interventions
- Other Nurse-Led Self-Management Support
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) encour - Other GP-follow up
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.
Primary outcome measures
- Proportion of participants achieving target serum urate (s-urate) concentration [Time frame: 52 weeks]
- Gout impact [Time frame: 52 weeks]
Secondary outcome measures (2)
- Quality of life one year after discharge from a rheumatology clinic indicated by EQ-5D-5L. [Time frame: 52 weeks]
- Proportion of participants adherent to urate lowering drugs based on CQR-5 [Time frame: 52 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Denmark · 5 centers
- Aarhus University Hospital — Aarhus
- Gødstrup Hospital — Herning
- Horsens Hospital — Horsens
- Randers Hospital — Randers
- Silkeborg Hospital — Silkeborg
Identifiers
NCT: NCT06971146 · 1-10-72-165-24 · 2096-00035B