The Stroke Box: a patient-centered eHealth approach for improving post-stroke care.

Although there have been major advances in (personalized) stroke treatment in
the last decade, the need for prevention of stroke remains critical. Prevention
of recurrent stroke is currently primarily organized through management of
cardiovascular risk factors including lifestyle, hypertension and atrial
fibrillation (AF). To improve the cardiovascular risk management of stroke
patients, more frequent measurements of blood pressure and heart rhythm are
essential. Besides this, actively engaging the patient with their own recovery
could lead to an improved lifestyle. Recent studies have shown telemonitoring
of patients can improve care, help with prevention of disease, and reduce
healthcare costs, whilst keeping the patient more engaged with their disease.
The LUMC *Box* has shown to effectively monitor blood pressure of patients
after myocardial infarction with equal results and patient satisfaction rates
compared to standard care. We plan to use this framework for improving
post-stroke care by introducing more frequent blood pressure and heart rhythm
measurements. Additionally, we will provide more information around lifestyle
improvement and have the patient actively engage with their weight and physical
activity.
In this study we will be evaluating the technical feasibility and clinical
implementation of the home-based self-measurements using the Box in a
post-stroke pilot setting: the Stroke Box. The results will be used as a basis
for the power calculation in the future randomized clinical trial.

The overall aim of this pilot is to evaluate the technical feasibility and
clinical implementation of the Stroke Box by evaluating user experience and
hypertension management. The primary objective is gathering data on blood
pressure management for power calculation for a future randomized clinical
trial where the effect of the Stroke Box on hypertension management will be
studied. The secondary objectives will be gathering and evaluating data on
heart rhythm, weight and activity of patients using the Stroke Box, evaluating
the technical- and workflow implementation for healthcare professionals,
evaluating the self-management and user-experience of patients, assessing the
patient adherence to the self-measurements and pharmacotherapeutic prophylactic
therapy, and evaluating the correct functioning of the IT infrastructure,
hardware and LUMC Care app, and to assess the correct use of all stakeholders
involved in the eHealth support and telemonitoring with the Stroke Box.

This study is a prospective cohort study to evaluate the implementation of the
Stroke Box and gather data. For the first 5 patients we will mainly evaluate
the technical procedures of the study in addition to the other objectives. For
the remainder, we will be gathering data on blood pressure management, patient
engagement and have a user-based evaluation of the eHealth infrastructure
during a six-month follow-up period. We will do evaluations of the collected
data based on a before-after comparison of blood pressure and questionnaire
results.

The Stroke Box containing a blood pressure monitor, weighing scale, single-lead
ECG wristwatch with activity tracking and associated apps.

Patients are asked to measure weight, blood pressure and heart rate on a daily
basis, which takes approximately 5-10 minutes. In addition, all patients will
be asked to fill in a questionnaire at the start and the end of the study. All
devices used by patients for personal management in this study are
non-invasive, easy-to-use, CE marked and electrically safe within their
intended use. Using the devices is with very limited risks.
This study has several potential benefits for patients. First, patients can
measure their own blood pressure, pulse and weight, which can reassure patients
and give them more insight in their own health (the so-called *patient
empowerment*). Furthermore, this data gives the GP or GP nurse more insight in
the health status of patients, potentially leading to better cardiovascular
risk management and hypertension control. Finally, we will be evaluating the
ECG diagrams of the patients at risk for atrial fibrillation (AF) at the end of
the pilot and inform them of suspected signs of AF.