Nurse-Led Telehealth for Gout (GoutConnect)

University of Aarhus

Status: Not yet enrolling

Conditions: Gout Arthritis; Gout Initiating Urate-loweringUrate-lowering Therapy; Digital Health; Adherence; Telehealth; Health Literacy

Treatments: Other: The nurse-led self-management support intervention; Other: GP-follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT06971146

1-10-72-165-24

2096-00035B (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this clinical trial is to test whether a nurse-led telehealth support can help people with gout better manage their condition and stick to their urate-lowering medication after they leave care at a rheumatology clinic.

One group will receive nurse-led telehealth support, while the other group will return to follow-up with their regular doctor (general practitioner). The study includes adults with gout who meet specific medical criteria and are taking medication such as Allopurinol or Adenuric. Participants must also be able to read and write Danish.

The aim is to help patients reach a healthy uric acid level in their blood after 52 weeks. Those in the nurse-led group can choose one of four types of support:

1. App-Based Support - an app gives information and reminders.
2. Letter Reminders - messages are sent through digital or postal mail.
3. Text Reminders - SMS messages are sent every three months.
4. Phone Support - nurses call three times a year to check in. Participants will be recruited from five hospitals in Central Denmark.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

The nurse-led self-management support intervention

Experimental group

Treatment:

Other: The nurse-led self-management support intervention

GP-follow up

Active Comparator group

Treatment:

Other: GP-follow up