B.p.h. Pouls 1,2, B.j.f. Van Den Bemt 1,2, A.l. Gaffo 3, M. Flendrie 1
1 Sint Maartenskliniek, Nijmegen, The Netherlands, ² Radboud University Medical Centre, Nijmegen, The Netherlands, ³ University of Alabama Medical Centre, Birmingham, United States of America
Background: Gout flares are considered a key outcome measure in gout treatment. Early treatment of gout flares increases patient well-being and warrants timely notification of the treating clinician. Recently, a four-criteria gout flare definition has been developed and validated for use in clinical trials . This study tests the usability, patient value and feasibility of a smartphone app applying the gout flare definition to detect gout flares in real-time.
Objective: To test an electronic application (Q1.6 app) for daily monitoring of patient-reported gout flares using a validated four-criteria gout flare definition .
Methods: Thirty patients will be recruited during visit at the outpatient rheumatology clinic in this prospective feasibility study (Dutch Trial Register: NTR7226). Inclusion criteria are age ≥ 18 years, in possession of an Android or iOS-based smartphone, diagnosis of crystal proven gout or a high clinical suspicion of gout and at least one (possible) flare reported in the last three months
Patients are followed for 3 months in which they actively use the Q1.6 application. Q1.6 is a straight-forward query app that has been customised to incorporate a modified version of the 2017 four-criteria gout flare definition . On a daily basis the Q1.6 app asks current pain score on a scale from zero to ten as screener question. Scoring pain below a four terminates the query. When scoring above three the app continues the query with the remaining three gout flare definition criteria: does the patient experience warm and/or swollen joints and does he/she regard this as a flare. Responses are transmitted in real-time to the clinicians dashboard. Also, email alerts are generated when a participant reports a flare, scores pain above three for 3 consecutive days or is inactive for 5 days. End of study evaluation consists of a questionnaire, based on the Technology Acceptance Model (TAM) . This model addresses ease of use (System Usability Scale) , perceived usefulness and attitude towards using (uMARS) . All constructs will be analysed using descriptive statistics.
(Preliminary) Results: The feasibility trial started in November 2018. At the time of submission 7 patients (23%) have been included and expectations are inclusion is completed by April 2019. None have prematurely quit. So far a total of 254 queries have been posed and only two responses have been missed (0,8%). There have been no technical issues. One flare has been reported and that same day the rheumatologist called the patient to proactively provide care.
Conclusion: This prospective study assesses feasibility of using an app for home monitoring of gout flares in 30 patients. Preliminary results in 7 patients are encouraging regarding technical functionality, query adherence and app attrition. If our electronic application proves feasible and accurate it can improve ascertainment of gout flares in daily practice which is a significant gap in the field.
References: 1. Gaffo AL, Dalbeth N, Saag KG, et al. Brief Report: Validation of a Definition of Flare in Patients With Established Gout. Arthritis Rheumatol. 2018;70(3):462-467. 2. Davis Jr. FD. A Technology Acceptance Model for empirically testing new end-user information systems: theory and results. MIT PhD thesis. 1985. 3. Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016;4(2):e72.