Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06971146

Health Literacy-Based Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial

Led by University of Aarhus · Updated on 2025-09-18

200

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether nurse-led telehealth support can help adults with gout better manage their condition and stick to their urate-lowering medication after leaving a rheumatology clinic. The study focuses on patients who have reached target serum urate levels and aims to support ongoing management over a 52-week period. Participants will be adults diagnosed with gout who are taking medications like allopurinol or Adenuric and can read and write Danish. Participants are randomly assigned to one of two groups: the intervention group receives nurse-led telehealth support with four options to choose from, including app-based information and reminders, letter reminders, SMS reminders every three months, or phone calls from nurses three times a year. The control group receives usual care, continuing follow-up with their general practitioner after hospital discharge, with information and recommendations sent to both the GP and the patient. During the study, participants will be monitored for maintaining healthy uric acid levels and the impact of gout on their lives after 52 weeks. Researchers will assess medication adherence and quality of life using questionnaires. The study includes ongoing support and follow-up to help participants manage their gout effectively, with all outcomes tracked over the course of one year.

CONDITIONS

Brief Title

Nurse-Led Telehealth for Gout

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Diagnosed with gout according to ACR/EULAR 2015 criteria
  • Estimated Glomerular Filtration Rate (e-GFR) greater than 30 ml/min
  • Prescribed allopurinol or Adenuric and achieved two consecutive serum urate levels below 0.36 mmol/L (or below 0.30 mmol/L for patients with tophi)
  • Able to read and write Danish well enough to understand information and complete questionnaires
Not Eligible

You will not qualify if you...

  • Cognitively impaired and unable to understand or give informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Nurse-Led Self-Management Support

Duration - 52 weeks

Participants choose from four support options including app-based monitoring, quarterly reminders by letter or SMS, or phone call check-ins by a nurse to support gout self-management.

Quarterly contacts via app, letter, SMS, or phone calls depending on participant choice

GP Follow-up

Duration - 52 weeks

Participants in the control group continue with routine care by their general practitioner including annual monitoring and treatment according to discharge recommendations.

Annual visit with general practitioner

Trial Site Locations

Total: 5 locations

1

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

2

Gødstrup Hospital

Herning, Denmark, 7400

Actively Recruiting

3

Horsens Hospital

Horsens, Denmark, 8700

Actively Recruiting

4

Randers Hospital

Randers, Denmark, 8930

Actively Recruiting

5

Silkeborg Hospital

Silkeborg, Denmark, 8600

Actively Recruiting

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Research Team

A

Annette de Thurah, CNS, MPH, PHD

S

Sofie B Vestergaard, RN, MSc, PhD-fellow

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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