Serum urate home monitoring for gout using a Point-of-Care Testing Meter and nurse-led treat-to-target approach: A feasibility study

Gout is one of the most common inflammatory rheumatic disorders, with an
expected prevalence of 580,000 in the Netherlands by 2030, corresponding to
3.3% of the current Dutch population of 17.5 million. The disease arises from
the deposition of sodium urate crystals when serum urate (sUA) consistently
exceeds saturation. Deposition of these crystals can lead to intense joint
pain, joint damage, and subcutaneous nodules. Fortunately, gout can be
effectively treated, with a central role for urate-lowering therapy (ULT). A
'treat-to-target' (T2T) approach, titrating doses of urate-lowering therapy
until a target value of sUA below 0.36 mmol/L is achieved, prevents the
occurrence of future attacks.

Unfortunately, some gout patients are inadequately treated with ULT, resulting
in unnecessary attacks. Research indicates that 1) patients with an indication
for ULT sometimes do not receive this treatment, and 2) the T2T approach is not
always (sufficiently) employed to effectively control sUA levels. Lastly,
adherence to ULT is generally low among gout patients, leading to uncontrolled
disease.

In their groundbreaking research, Doherty et al. demonstrate that nurse-led
care and a strict T2T strategy (with intensive monitoring and support) can lead
to 95% of gout patients achieving treatment goals, followed by a significant
reduction in gout attacks after two years. Other studies also show promising
results with nurse-led care. However, this form of care is labor-intensive. The
increasing prevalence of gout and the resulting pressure on healthcare
professionals underscore the need to integrate innovative solutions to ensure
the accessibility and affordability of healthcare.

Supporting patient self-management via eHealth can be a promising addition to
gout care, providing the opportunity for additional information, education, and
monitoring, possibly in a more automated manner. An intervention with a
nurse-led T2T strategy, combined with self-monitoring using a digital uric acid
meter and digital communication with nurses, can increase patient engagement
and adherence. Greater patient engagement, adherence, and task delegation to
specialized nurses can improve the efficiency of care while maintaining its
quality. In secondary care, efficiency is crucial, as the greatest gains can be
achieved in the efficiency of care, as opposed to quality. Patients and
healthcare providers were positive about a nurse-led T2T strategy combined with
home uric acid monitoring after a pilot project at the Sint Maartenskliniek,
and important considerations for the use of such a strategy in clinical
practice were obtained.

However, more scientific evidence is needed on the feasibility of using home
monitoring to better understand how the intervention can add value and meet the
needs of patients and healthcare providers, improving the chances of successful
implementation.

The current research aims to evaluate the feasibility of home monitoring of sUA
using a digital uric acid meter and a nurse-led T2T approach in secondary care.

This research aims to examine the feasibility of home monitoring of serum uric
acid for both patients and stakeholders, using a digital home measuring device
in conjunction with a nurse-led T2T approach.

Primary research question:
What is the feasibility of home monitoring of sUA and nurse-led care for both
patients and stakeholders in secondary care?

Secondary research questions:
a) How often do patients achieve the sUA goal after 24 weeks?
b) What is the average dose of uric acid-lowering therapy after 24 weeks?
c) How many attacks do patients experience on average after 24 weeks?
d) What is the adherence to the intervention after 24 weeks?
e) What is the average healthcare utilization after 24 weeks?
f) How does patient activation change before and after the intervention (24
weeks)?
g) How does health-related quality of life change before and after the
intervention (24 weeks)?
h) How do beliefs about ULT medication change before and after the intervention
(24 weeks)?

A prospective descriptive study will be conducted at the Sint Maartenskliniek
in Nijmegen to evaluate the feasibility of home monitoring of sUA in
combination with a nurse-led T2T approach. We will use Bowen's feasibility
framework to guide data collection in this study, as we aim to assess multiple
feasibility focus areas. The included areas are acceptance, demand,
implementation, integration, practicality, and limited effectiveness (Table 2
in the protocol).

We will have two types of participants: (1) patients (n = 30) and (2)
stakeholders (n ~ 7). Included patients will receive instructions to use a
digital uric acid meter for home monitoring of serum urate and digitally
communicate values through a questionnaire sent every 4 weeks. This
questionnaire will also collect data on side effects, attacks, and any
questions or comments. The specialized nurse will coordinate care, provide
explanations and instructions on home monitoring, advise patients on medication
dosage and lifestyle, and may decide to refer patients to other healthcare
providers (e.g., rheumatologist). Additional questionnaires will be sent to
assess feasibility and secondary outcomes at baseline, 12 weeks, and 24 weeks.
A review of medical records will provide insight into clinical results and
patient characteristics during the research period. All participants are part
of the intervention group, and the experiences of patients and stakeholders
with the intervention are the primary outcome of the study. Therefore, no
control group is included in this study. Finally, stakeholders, including
healthcare providers (HCPs) and management personnel involved in the use and
implementation of sUA home monitoring, will be invited to participate in
interviews. Healthcare providers will be asked to keep a diary in which they
report obstacles/problems they encounter or any other comments.

Intervention for Patient Participants:

An overview of the intervention and procedures can be seen in Table 1 of the
protocol. Patients wishing to participate (see section 12.2 for the consent
procedure) are instructed on the use of the digital meter, which reads the uric
acid level through a small finger prick, and the remote communication of the
measured values. When obtaining informed consent, patients are asked whether
they prefer personal instruction (Face-to-Face, (F2F)) for using the device, or
if the instructional manual and a digital video would be sufficient. In the
latter case, the device is sent by mail. Information is digitally sent,
including written and video instructions explaining self-measurement,
information about home monitoring of sUA and its objectives, contact details of
healthcare providers, and a troubleshooting page in case of issues during
self-measurement. If a patient wishes to receive personal instructions, an
instruction session with a medical assistant is scheduled before the first home
measurement.

Patients are instructed to measure their sUA levels at home every four weeks
using the digital uric acid meter and digitally communicate their measured
value, any (health) issues, symptoms, potential side effects, questions, and
comments in a questionnaire that is sent every 4 weeks. The same 4-weekly
questionnaire digitally obtains information about gout attacks. Reminders are
automatically sent twice after 3 and 7 days if a patient does not communicate
their value within 3 days of the intended measurement date. Additionally,
patients can present more urgent medical questions or issues to the specialized
nurse via email contact or by calling the usual phone number.

Medication Treatment Strategy:
The local protocol will be followed, with allopurinol as the first drug of
choice. In case of toxicity or treatment failure, uric acid-lowering therapy
will be switched to benzbromarone or febuxostat according to the local
protocol. There are no differences in the medication treatment strategy
compared to usual care.

Monitoring Medication Toxicity:
Regular laboratory tests, including sUA, complete blood count, creatinine, and
ALT (alanine transaminase), are performed every 4-6 weeks through venous
puncture in usual care. In this study, regular laboratory tests are conducted
in week 8 and at the end of the study (week 24) to monitor the toxicity of uric
acid-lowering therapy. If deemed necessary by the treating physician, toxicity
tests will be conducted more frequently, for example, in patients at higher
risk for medication toxicity, such as those with reduced kidney function, i.e.,
CKD-EPI between 0.45 and 0.90 ml/min/1.73m². Lab tests are reviewed by the
study rheumatologist (MF), and the advice is communicated to the patient by a
specialized nurse. In case of suspected acute toxicity and the need for acute
changes in the medication regimen, the study physician will directly contact
the patient.

All provided care will follow the recommended treat-to-target approach for
gout. Completed values, questions, and other parts of the 4-weekly
questionnaire are reviewed by specialized nurses every Tuesday and Friday. At
these times, emails are also answered by specialized nurses. For very urgent
questions, such as experiencing a gout attack, patients are advised to call the
hospital, as in usual care. In case of questions, the nurse (possibly in
collaboration with the rheumatologist) will take appropriate actions, as
applicable in usual care. After 24 weeks, the study ends, and the final
measurements are conducted. The intervention places more emphasis on scheduling
the first (lengthy) consultation with a specialized nurse within 8 weeks of
starting ULT. Consultations with specialized nurses will occur more frequently
than in usual care, namely at 5 weeks, with the possibility of healthcare
provider and patient initiated contact outside these moments. During the
intervention, patients do not have standard appointments with a rheumatologist,
unlike in usual care. Therefore, patients in this intervention will have
approximately 2 fewer consultations with a rheumatologist than in usual care.

Intervention for Stakeholders:

In this study, the specialized nurse coordinates care and treatment, advises
patients on medication dosage and lifestyle, and refers to other healthcare
providers (medical assistant (for finger prick instructions) or the
rheumatologist if necessary).

Patient subjects will be asked to record their sUA at home every four weeks
using a fingerpick device for 24 weeks. While the intervention is invasive, the
burden on patient subjects is considered low. Compared to usual care, subjects
will experience a finger prick seven times in total, resulting in approx. 2-3
less lab visits and venapunctures compared to usual care. The intervention is
expected to lead to improved adherence to ULT medication and thereby reduced
sUA levels and improved clinical outcomes. Additionally, fewer face-to-face
visits, less rheumatologist contact and lab tests are expected which will
reduce patient burden, travel time and costs. Patients have more frequent and
easily accessible contact with the specialized nurse. Patients have more
frequent and easily accessible contact with the rheumatology nurse.Small risks
that might be associated with participation in this study are 1) burden of the
finger prick 2. responsibility to perform POCT at home, 3. Less therapy
adherence due to additional patient responsibility. However for the latter,
patients that consistently do not comply will be referred back to usual care.
Additionally, subjects have to fill in questionnaires at baseline (30 min.), 12
weeks (20 min.) and 24 weeks (40 min). No extra visits will be planned for this
study.