Testing an increased visit interval scHeme UsIng web-based Self-evaluation (THUIS-study)

Juvenile Idiopathic Arthritis (JIA) is one of the most common chronic rheumatic
diseases in childhood (Prakken et al., 2011). This
chronic disease has a major impact on the functioning and happiness of a child
(Gutiérrez-Suárez et al., 2007; Haverman et al.,
2012; Sawyer et al., 2004; Tollisen et al., 2018).

Currently, when during several visits a stable low disease activity is
achieved, the interval between visits is often increased by the
physician. We think this decision to increase visit intervals can also be made
by the patient based on a self-evaluation by filling in the JAMAR questionnaire
for JIA specific measures (such as the number of involved joints, functional
status and drug side-effects) and the EQ-5D-5L-Y questionnaire for overall
quality of life (pain, well-being, etc.) (Otto et al., 2018; Scott et al.,
2019; Wille et al., 2010).

JIA is a remitting relapsing disorder. At every clinical visit the juvenile
arthritis disease activity score (JADAS) is determined. The
JADAS is a composite score, including an inflamed joint count by the physician,
a physician global assessment (PGA) and a patient
severity score measured on a visual analogue scale (VAS) (Consolaro et al.,
2009, 2014; Swart et al., 2018). Our treatment aim is to
obtain the lowest (best) JADAS score possible. During routine monitoring
currently performed, the scores from our electronic medical
record (HIX) are transferred to our research data platform (RDP). Here we
calculated the number of disease flares (JADAS score of
>3) at a follow up visit in the past 5 years to be around 14%.

We want to show that patients that replace the outpatient's clinic visit by
home-monitoring, thus providing the medical team with a JAMAR and EQ-5D-5L-Y,
have a disease outcome that is not worse than patients that routinely visit the
clinic on a 3 months interval. Possible disease worsening will be monitored by
the physician together with the nurse using the answers given by the patient in
the questionnaires. When deemed necessary, the
physician will contact the patient and the visit can be rescheduled at the
earliest time possible. Signs of such worsening are an increase in pain
intensity and the number of joints involved, an increase in the duration of
morning stiffness and worsening of the patient-reported overall disease
severity score.

Our objective is to safely increase the visit interval to 6 months in JIA
patients with stable disease. The skipped 3-month visit is
replaced by a self-evaluation via e-mail by EQ-5D-5L-Y and JAMAR questionnaires
that will be send via Castor EDC. The
overall disease outcome, defined as the number of disease flares measured, is
not worse compared with the historical data of
routine clinical care measured in the previous years (2015-2019, data present
in Research Data Platform).

This is a non-inferiority study where a study cohort is compared to a historic
control cohort.

There is only one study group. All participant patients will be offered a
control interval of 6 months instead of the current 3 months. All patients will
complete a JAMAR and EQ-5D-5L-Y questionnaire for self evaluation. At 3 months
such an evaluation will replace a hospital visit. Questionnaires will be send
via e-mail using Castor EDC. If deemed necessary by the treating physician, the
participant will receive a lab form for drawing blood at their general
practicioner at 3 months. The lab results will be send to the research team in
order to monitor toxicity of medication.

There is no extra burden associated with study participation. It is already
current practice for our JIA patients to complete a JAMAR questionnaire during
regular visits. A potential risk is worsening of disease activity without the
patient noticing. Therefore, only patients in stable disease are invited to
participate. The risk of a flare in this group of patients is low. Benefit is
the increase in follow up interval, reducing the number of visits to the
outpatient clinic. There is no study drug used.