Effectiveness and cost-effectiveness of monitoring spondyloarthritis with the integrated eHealth system SpA-Net: a randomized controlled trial

Spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease with a
heterogeneous presentation. Regular and personalised monitoring of disease
activity, physical functioning, medication use and side effects is essential to
improve and maintain patients* health-related quality of life (HRQoL) in SpA.
Furthermore, care provided should be patient-centred, involving patients in
treatment decisions and incorporating personal preferences, needs and values.
Increasingly, transparency on outcomes of care delivered and efficiency of care
are demanded. In daily practice, capacity issues, time constraints, lack of
optimal tools for monitoring and providing transparency may hinder these
important aspects of quality of care.

Traditionally outpatient visits are pre-booked every 3-6 months, but these are
frequently unnecessary in patients with stable disease. Remote monitoring
through a web application (telemonitoring) could be a solution for these
patients. Telemonitoring has been shown to be possible, effective and safe in
several chronic diseases, and clearly reduced health care utilization. To date,
this has never been tested in SpA.
In 2016, a web-based eHealth system for patients with SpA in the Netherlands
(*SpA-Net*) was developed as a personal monitoring system. SpA-Net includes
clinical information on medication use, laboratory tests, several patient
reported outcomes and a personal treatment plan, providing a comprehensive view
of the patient for the rheumatologists. An excerpt of this is available to
patients. This serves as the basis for each outpatient consultation. Since
2016, SpA-Net has been increasingly used in daily practice. Focus interviews
among patients and care providers showed high satisfaction and acceptance of
SpA-Net. It is, however, unknown whether SpA-Net can also be used as a
telemonitoring system, thereby replacing face-to-face consultations, and
leading to a reduction in health care utilisation.

In this study, remote care (telemonitoring) provided through SpA-Net, in
combination with patient-initiated care, is compared with standard care, aiming
at more efficient care. Concomitantly, a trial-based cost-utility analysis will
be performed.

Primary Objective: to determine whether telemonitoring through SpA-Net, in
combination with patient-initiated care, leads to less outpatient visits
compared with standard care.

Secondary Objective(s): to determine whether telemonitoring through SpA-Net
does not compromise quality of care, patient satisfaction and health outcomes.
Concomitantly, cost-effectiveness of the telemonitoring intervention will be
assessed from a healthcare and societal perspective.

Multicentre, pragmatic, randomized controlled trial, alongside a trial-based
cost-utility analysis

Telemonitoring arm: Patients are remotely followed with the online personal
monitoring system SpA-Net and one pre-booked annual visit at the outpatient
clinic.

Standard care: Patients are followed with regular pre-booked outpatient visits
as usual, also using SpA-Net. Due to the COVID-pandemic these outpatient visits
may also take place through telephone or video calls, replacing physical
visits.

SpA-Net is currently used in daily practice in all participating centres for
regular follow up of patients with SpA. Patients participating in the current
trial will receive treatment as usual according to good clinical practice. The
standard care group will complete questionnaires and have blood tests done as
usual prior to each visit at the outpatient clinic. The visits will be
scheduled at the discretion of the treating physician. The telemonitoring group
will complete questionnaires and have blood tests done at baseline, after 6
months and after 1 year. Outpatient visits will be scheduled at baseline and
after 1 year. At any time, patients from either arm may contact the
rheumatology department and extra visits can be scheduled. There is no risk
involved.