A self-management app in a digital treat-to-target gout-care approach: the ReMonit Gout feasibility study.

Abstract

Objective: A self-management app, Urika, was developed to remotely monitor and support patients when initiating urate-lowering therapy (ULT). The objective was to test the overall feasibility of a future randomized controlled trial of a digital treat-to-target gout-care approach using Urika in secondary care.

Method: Feasibility was tested among patients with gout in specialized healthcare over 3 months. The predefined set of feasibility criteria included aspects of technical, operational, and trial feasibility, as well as the feasibility of collecting clinical outcomes. Overall feasibility would be deemed acceptable if ≥ 70% of the predefined criteria were achieved. Patient participants entered their measured serum urate, ULT medication, start dose, and flare medication into the app. The app provided instructions about dose escalations. Patient characteristics and patient-reported outcome measures were collected by digital questionnaires, and app experiences were collected in semi-structured telephone interviews.

Results: The study included 21 males aged 29-71 years. In total, 27/31 (87%) of the predefined feasibility criteria were achieved, 85% of patients rated their satisfaction with the app ≥ 8 on a 0-10 numeric rating scale, and 90% reported being satisfied/very satisfied with the gout treatment. Ten patients were interviewed, giving mainly positive feedback on the Urika app. No safety issues were identified in this small sample.

Conclusion: The overall feasibility of the Urika app and the study logistics were satisfactory. The study results have been used to improve the app functions and decide study logistics in an ongoing randomized controlled trial of a digital treat-to-target gout-care approach.Trial Registration Number: ClinicalTrials.gov: NCT06211322, registered 18 January 2024.