Nurse-Led Telehealth for Gout

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06971146
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-05
• Study Start: 2025-06-15
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving target serum urate (s-urate) concentration	52 weeks	The number and proportion of participants with a serum urate concentration equal to or less than 0.36 mmol/L or 0.30 mmol/L if tophi, at 52 weeks after randomization.
Gout impact	52 weeks	Changes in Gout Impact Scale (GIS). GIS is a patient-reported outcome measure assessing the impact of gout on health-related quality of life. The GIS includes domains such as gout concern overall, gout medication side effects, unmet treatment need, well-being during gout attack, and concern during gout attack. Each domain is scored on a 0-100 scale, with higher scores indicating greater impact (worse health status).; Change from baseline to week 52 will be calculated, with negative change scores indicating improvement (i.e., reduced gout impact).

Secondary Outcome Measures

Name	Time	Method
Proportion of participants adherent to urate lowering drugs based on CQR-5	52 weeks	Adherence to urate lowering drugs will be assessed using the Compliance Questionnaire Rheumatology 5-item version (CQR-5). The CQR-5 is a patient-reported questionnaire specifically developed to measure adherence in patients with rheumatic diseases. Each item is scored on a 4-point Likert scale, and an overall adherence score is calculated. Participants will be classified as adherent if their CQR-5 score is above the predefined threshold for good adherence (e.g., ≥80% predicted probability of adherence based on validated cutoff.)
Quality of life one year after discharge from a rheumatology clinic indicated by EQ-5D-5L.	52 weeks	The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group, covering five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. An index score will be calculated based on country-specific value sets, with scores typically ranging from \<0 (worse than death) to 1 (perfect health). Change from baseline to week 52 will be assessed, with positive changes indicating improvement in health-related quality of life.