The Remote Monitoring of Gout Feasibility Study

Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility.

Acceptable number of errors (≤5 errors per participant) in the performance and functionality experienced by the patients and project group members

Considered feasible if the System Usability Scale median score is ≥68 on a 0-100 scale, 100= best score

Open responses will be collected in semi-structured interview. No scales or instruments will be used

Measured by registering amount of time spent (minutes) on training

Measured by a numeric rating scale (NRS) 0-10, higher scores mean better outcome. Acceptable feasibility if >=70% of the participants report score >=5, otherwise considered not acceptable feasibility.

Measured by registering time spent on screening and enrollment

Considered feasible if there is available data on serum urate levels for ≥90% of patients for calculation of mean levels and proportion with low serum urate level

Total number of reported errors related to the software functionality (e.g., downloading, login, registration of medication, reminders, access to videos, medication adherence, registration of blood test results, urate level graph, blood test history, chat, request new prescription). Considered acceptable feasibility if the number of errors are ≤5 per patient in the performance and functionality experienced by the patients and project group members.

Considered feasible if patient-reported data and the medication history in the app monitored in the platform for health personnel is available for ≥90% of patients.

Patient-reported Medication Adherence Report Scale (MARS-5), score range 5-25, higher scores mean better adherence. Considered acceptable feasibility if >=90% of the patients complete the instrument.

Number of acute gout flares

Number of side-effects registered in the app or by study nurse or study coordinator

Number of adverse events (incl. serious adverse events) registered by study medical doctor, study nurse or study coordinator

Measured by a single item with 5 response categories, ranging from very dissatisfied to very satisfied, higher scores mean higher satisfaction. Considered acceptable feasibility if >=70% of the participants report to be satisfied or very satisfied.

Measured by the Gout Knowledge Questionnaire, 0-10, higher scores mean better outcome. Considered acceptable feasibility if there is available total score data for >=90% of the patients.

Measured by a numeric rating scale (NRS) 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.

Measured by the Euro Quality of Life 5 Dimensions 5 Levels, each item is scored 1-5, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.

Measured by Work Productivity and Activity Impairment (WPAI) item no.6, 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.

Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported visits in specialist or primary healthcare

Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported time for travelling to the hospital

Considered acceptable feasibility if there is available data for ≥90% of participants using self-report

Number of eligible patients per month.

Acceptable recruitment rate is ≥50% of eligible patients.

Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.

Acceptable overall trial logistics (Identification, screening, recruitment, patient training, data collections, monitoring blood test results, renewal of prescriptions) evaluated as Yes vs. No by the study group.

Count the number of videos watched per participant. Considered acceptable feasibility if ≥70% of the participants have watched at least 1 video.

Count the number of registrations of daily medication adherence. Considered acceptable feasibility if ≥70% of the participants have registered at least 1 adherence.

Count the number of registered serum urate levels. Considered acceptable feasibility if ≥90% of the patients register their serum urate level monthly.

Count the number of chat messages. Considered acceptable feasibility if ≥70% of the participants register at least 1 chat message.

Count the number of flare registering. Considered acceptable feasibility if ≥10% of the participants register 1 flare.

Incidence of hinders that could harm a successful clinical evaluation of the app in a large randomised, controlled trial.