Nurse-Led Telehealth for Gout

Condition(s) studied

Investigational drug(s) / intervention(s)

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) 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.

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.

Study 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

Primary outcome measure(s)

• Proportion of participants achieving target serum urate (s-urate) concentration — 52 weeks
  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.
• Gout impact — 52 weeks
  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).

Trial sites (5)

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