Clinical trial NCT06971146: Nurse-Led Telehealth for Gout
Official title: Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Literacy
Gout Arthritis
Gout Initiating Urate-loweringUrate-lowering Therapy
Telehealth
Digital Health
Adherence
Keywords: self-managment
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Silkeborg
name: Gødstrup Hospital
name: Randers Regional Hospital
name: Regionshospitalet Horsens
First posted: 2025-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, randomized controlled superiority trial with two parallel groups
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 criteria: 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.

Primary outcomes:
measure: Proportion of participants achieving target serum urate (s-urate) concentration
timeFrame: 52 weeks
measure: Gout impact
timeFrame: 52 weeks
Secondary outcomes:
measure: Quality of life one year after discharge from a rheumatology clinic indicated by EQ-5D-5L.
timeFrame: 52 weeks
measure: Proportion of participants adherent to urate lowering drugs based on CQR-5
timeFrame: 52 weeks
Other outcomes:
measure: Need for acute healthcare visits
timeFrame: 52 weeks
measure: All contacts to the rheumatology department
timeFrame: 52 weeks
measure: Change in Gout-related Global Assessment (PGA) score
timeFrame: 52 weeks
measure: Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score
timeFrame: 52 weeks
measure: Number of gout flares
timeFrame: 40 and 52 weeks
measure: Change in gout related pain measured by Visual Analog Scale (VAS)
timeFrame: 40 and 52 weeks
Locations:
Study officials:
References: