The Remote Monitoring of Gout Feasibility Study in Primary Care

Feasibility criteria:

• No serious and irreversible errors in app
• Mean System Usability Scale score ≥68
• 70% with score ≥5 on a numeric rating scale (0-10) on patient satisfaction with the app
• No serious and irreversible barriers to app-supported follow up experienced by patients or GPs
• No other serious and irreversible problems with the app

Feasibility criteria:

• Recruitment rate ≥50% of eligible patients
• Withdrawal rate ≤20% of included patients
• ≥90% of the patients register their sUA level in the app throughout the study
• ≥90% of the patients answer baseline and 3 months questionnaires
• No serious and irreversible risks or challenges that could hinder a successful clinical evaluation of the app in a large randomised controlled trial

Number and type of technical errors in app reported by patients through the app and in questionnares at 3 months.

Patient experiences of app performance, functionality and ease of use. From semi-structured interviews.

Patient reported software usability, measured with The System Usability Scale (SUS), sum score 0-40 converted into 0-100, 100 = best score. From questionnaire at 3 months.

Patient satisfaction with the app, measured with one item rated on a 0-10 numeric rating scale, ranging from 'very dissatisfied' (0) to 'very satisfied' (10), from questionnaire at 3 months.

Patients perceived benefits and disadvantages with the app collected from semi-structured interviews.

Patient evaluation of the demo films and instruction manual. From semi-structured interviews.

Barriers and facilitators of app-supported gout follow-up experienced by patients and GPs. From semi-structured interviews and questionnaires at 3 months.

Participant satisfaction with the care, measured by one item from The Nordic Patient Experiences Questionnaire, with five point response options ranging from "Very satisfied" to "Very dissatisfied" from questionnaire at 3 months.

Number of patients screened, number of eligible patients, and the number of consenting patients every month, including information about how the patient was recruited. From identification and recruitment logs completed during the recruitment period and questionnaires at 3 months.

Number of patients that withdraw from the study, reasons for dropout (if provided). From logs completed during the study period.

Number of videos watched, registration of serum urate levels, medication adherence and flares in the app. From back-end data from the app and semi-structured interviews with patients.

Barriers and facilitators for study participation experienced by patients and GPs, from semi-structured interviews.

Number of GPs providing blood test results and number of missing blood-test results from GPs, from questionnaires at 3 months.

Number of correct, incorrect and missing serum urate level registrations in the app. Urate level registrations from app and urate levels from blood tests provided by GPs at 3 months.

Response-rate to baseline questionnaire. Response-rate to 3-month questionnaire.

The number of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE). From questionnaires at 3-months to patients and GPs.