Nurse-Led Telehealth for Gout

NCT06971146 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-09-18

No results posted yet for this 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.

Conditions

  • Health Literacy
  • Gout Arthritis
  • Gout Initiating Urate-loweringUrate-lowering Therapy
  • Telehealth
  • Digital Health
  • Adherence

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) 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.

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.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER
  • Regionshospitalet Silkeborg

    collaborator OTHER
  • Gødstrup Hospital

    collaborator OTHER
  • Randers Regional Hospital

    collaborator OTHER
  • Regionshospitalet Horsens

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-08-01
Completion
2027-08-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06971146 on ClinicalTrials.gov