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.

Uncontrolled gout is characterized by recurrent arthritis attacks in patients
with gout, also named gout flares. The occurrence and frequency of flares are
important outcome measures in clinical practice and clinical trials assessing
the response of new treatments. Furthermore, frequency of gout flares is an
important indicator for initiation of urate lowering therapy. However,
measuring gout flares and flare frequency is difficult. Patient reported flare
and physician observed flare are not always in accordance. Also, serum urate is
not a well correlating proxy for flares. Use of anti-inflammatory drugs as
proxy for flares has been described but has not been validated.

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. Patients recording the presence of
three or more criteria is associated with a positive prediction of 88% for a
gout flare as defined by the diagnostic standard investigator. This definition
has primarily been developed and validated for use in clinical studies. At
present no studies have investigated the use of these criteria in daily
clinical practice. In this study we want to test if it is feasible to apply the
gout flare definition at home using a mobile app.

The Q1.6 app is a newly developed smartphone PRO-platform (patient reported
outcome-platform), based on pushing questions on smartphone login with
predefinition of the type of question, question timing and frequency.
Additionally, questions can be adjusted according to answers given. Data are
transferred in real-time to the healthcare professional. This allows for
stricter monitoring of gout patients with avoidance of therapeutic delay, thus
improving patient outcome and quality of care.

The setup of Q1.6 using the gout flare definition has been designed by
healthcare professionals with patients in mind. In order to know if patients
value the chosen design for applying the gout flare definition, their attitude
towards the application has to be determined. The Technology Acceptance Model
(TAM) devised by Davis Jr describes user motivation as a combination of
perceived usefulness and ease of use which affects the attitude towards using
and which will eventually lead to actual system use. In the past decades, TAM
has become a widely accepted model in the field of information technologies and
has readily been applied to health care. Therefore the TAM will also be applied
to the Q1.6 app loaded with the gout flare definition.

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 can be used by patients at home. With this feasibility study
we want to assess what the perceived patients* value is of the Q1.6 gout app.

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

Primary research question:
What is the perceived patients* value of thirty patients of app-based platform
Q1.6 for identification of gout flares as operationalized by the perceived
usefulness and ease of use?

Secondary research questions:
a) What is the adherence to the Q1.6 gout app?
b) How often are gout flares reported per patient per 3 months?
c) What proportion of flares lasts longer than three days?

After inclusion, subjects install the app and record gout-activity daily,
guided by the app. One to four questions a day are asked over a period of three
months (see intervention for details). This information is encrypted and
directly send to a database that is only accessible to the researchers.

In case of a recorded gout flare in patients without a crystal proven diagnosis
(question 4: are you currently experiencing a gout flare answered by yes) they
will be invited by the rheumatology department, for an interim visit within 48
hours to obtain synovial fluid aspiration and confirm the gout flare. This is
the gold standard for diagnosis of gout and in accordance with the local gout
protocol.

Patients with a proven diagnosis will receive a telephone call from their
healthcare professional if the patient reported a pain score over 3 and at
least one warm or swollen joint for three consecutive days. The investigator
will support the patient with therapeutic advice according to local gout
protocol.

If subjects do not respond to the questions during a minimum of 5 consecutive
days, the subject will receive a phone call from the investigator. Purpose of
the call is to verify whether there is a technical problem or the subject has
willingly stopped using the Q1.6 application. Technical issues will be resolved
where possible. If the subject has willingly stopped the study will be brought
to an end.

When the period of 90 days has passed or the subject has prematurely stopped
using the Q1.6 application, the research will be brought to an end. Subjects
will receive the 'System Usability Scale' and 'Perceived Ease of Use'
questionnaires through email. Once completed the study will be terminated for
this particular subject.

App-based platform Q that will daily ask the user one to four questions
(depending on the answers) for 90 consecutive days.
These four questions are:

What is your current pain level? (rated 0 - 10)

If pain is rated >3 then the following questions will also be asked:

Are one or more of your joints swollen? (yes/no)
Are one or more of your joints warm? (yes/no)
Are you currently experiencing a gout flare? (yes/no)

The burden of participation in this research consists of one to four questions
asked through a mobile phone app for three consecutive months. The benefit that
participants receive is that there will be acted upon this generated output if
the patient reports a gout flare for at least three consecutive days.
Consequence of the use of the app-based platform Q is that the patient is
pro-actively asked to report symptoms instead of reactively. A possible medical
treatment will always follow usual care as defined by the local gout protocol.
Patients will not receive additional medication or invasive treatment (like a
venapunction) because of inclusion in this study. As such, burden for patients
is minimal and non-invasive. With this study, we hope to add a possible
monitoring step to the diagnosis and treatment of gout flares and as such help
to improve the health outcomes for patients with (high suspicion) of gout.