Nurse-Led Telehealth for Gout

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.

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).

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.

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.)

The difference in need for acute visits at rheumatologists of rheumatology nurses at the rheumatology department.

The total number of contacts (in-person visits, telephone consultations, video consultations, and written communications) between participants and the rheumatology department during the 52 weeks follow-up period. Contacts include both scheduled and unscheduled interactions related to the management of gout.

The Patient Global Assessment (VAS PGA) will be used to assess the patient's overall assessment of their disease status. The VAS PGA is a self-reported measure, where the participant marks their perceived disease activity on a 100 mm horizontal line, with 0 mm indicating "no disease activity" and 100 mm indicating "worst possible disease activity." Change from baseline to 12 months will be assessed, with a lower score indicating a reduction in perceived disease severity.

The Health Assessment Questionnaire Disability Index (HAQ-DI) will be used to assess functional disability in participants with gout. The HAQ-DI consists of 20 questions across 8 domains, including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each question is scored from 0 (no difficulty) to 3 (unable to perform), with a higher score indicating greater disability. Change in HAQ-DI score from baseline to 12 months will be assessed, with a reduction in score indicating improvement in functional status.

The total number of gout flares experienced by each participant during the 52 week follow-up period. A gout flare is defined as a self-reported episode of acute joint pain, swelling, and/or erythema consistent with gout.

Gout related pain will be assessed using a Visual Analog Scale (VAS), where participants rate their current level of pain on a 100 mm horizontal line ranging from 0 mm ("no pain") to 100 mm ("worst imaginable pain"). Change from baseline to 52 week will be calculated, with negative changes indicating a reduction in pain intensity