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: Nurse-Led Self-Management Support; 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 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.

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

Nurse-led self-management support

Experimental group

Treatment:

Other: Nurse-Led Self-Management Support

GP-follow up

Active Comparator group

Treatment:

Other: GP-follow up