Real-time monitoring the occurrence of gout flares in patients by incorporation of the 2017 gout flare definition into an eHealth platform. A feasibility study

Rationale: In current practice gout flares are recorded during outpatient clinic visits when flares have long past and thus are subject to recall bias. In the ideal situation gout flares are recorded while occurring. Recently, a four-criteria gout flare definition has been validated [Gaffo et al. Arthritis Rheumatol 2018]. This definition has primarily been developed and validated for use in clinical studies. In this study we want to test if it is feasible to apply the gout flare definition in the home situation using a mobile app.

Objective: Purpose of this descriptive study is to gauge the feasibility of the Q1.6 app as platform to measure gout flares in real time.

Study design: A descriptive cross-sectional study

Study population: Thirty adult patients with (a high clinical suspicion of) gout who have reported a gout flare in the last twelve months.

Intervention (if applicable): Use of mobile app Q1.6 which will ask 1 - 4 questions daily for three consecutive months concerning the presence of a possible gout flare.

Main study parameters/endpoints: The perceived patient’s value of the Q1.6 gout app as measured by the system usability scale (=perceived ease of use) and perceived usefulness questionnaire.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will be asked 1 – 4 questions daily through a mobile phone application for three consecutive months. At the end of the study several questionnaires have to be answered (digitally). There are no extra visits planned during this study. All other actions taken are part of usual care and are according to local gout protocol. Participation in the study will not lead to additional medical care, medication or diagnostic procedures. The burden on subjects is minimal and non-invasive.

We hypothesize that by combining the recently validated gout flare criteria with a patient-friendly app and real-time monitoring, we can implement a gout flare measure that is less prone to recall bias and can be used by patients at home. It could measure flares more accurate and create a possibility to act upon flares faster, thereby improving patient outcomes in a treat-to-target strategy.

T = 90 days

Use of mobile app Q1.6 which will ask 1 - 4 questions daily for three consecutive months concerning the presence of a possible gout flare.