Corsano CardioWatch 287-2 for Improved E-health MOnitoring Evaluation Study.

The research focuses on evaluating the Corsano CardioWatch 287-2 in comparison
to 'The Box' within the E-health care pathway. While 'The Box' is a valuable
and established tool for home measurements, it exhibits some limitations. The
main areas for potential improvement are increasing user-friendliness for
patients and usability for healthcare professionals. Therefore, the aim of this
research is to assess whether the Corsano CardioWatch 287-2 can address these
shortcomings, thereby enhancing the patient experience and health monitoring,
while retaining the valuable aspects of 'The Box'.

The primary objective of the study is to compare the parameters detected by
'The Box' during the E-health care pathway with those detected by the Corsano
CardioWatch 287-2.

The secondary objective is to evaluate the usability of the Corsano CardioWatch
287-2 compared to 'The Box' from the perspective of healthcare providers and
the user-friendliness from the perspective of patients.

The study is a single-center, single-arm, two-phase study. Only one group of
patients is approached for participation. The aim of the study is to compare
conventional treatment and monitoring methods within the E-health care pathway
with 'The Box' system in relation to the Corsano CardioWatch 287-2.

The study comprises two phases:

- **Phase 1:** Healthcare personnel do not have access to the data from the
Corsano CardioWatch 287-2.
- **Phase 2:** Access to data is granted solely for feedback purposes without
influencing clinical decisions.

In both phases, clinical data are retrospectively evaluated.

Three different analyses are performed:

1. Comparison of clinical parameters between the research device and the
conventional BOX.
2. Comparison of user-friendliness for patients with a Device User-Friendliness
Comparison Survey.
3. Comparison of usability for healthcare providers with a Usability Assessment
Survey.

Burden for the Participants:
- Number of Questionnaires:Participants are required to complete only one short
questionnaire regarding user-friendliness.
- Wearability:Patients are asked to wear the Corsano CardioWatch 287-2
throughout the study period. This device automatically measures vital
parameters such as heart rate, respiratory rate, activity, sleep, SpO2, and
body temperature. To obtain an ECG, patients need to press the watch for 30
seconds once a day.
- Study Location: The study takes place at a single center, namely the Leiden
University Medical Center (LUMC).

Risks for the Participants:
- Physical Burden: The physical burden is minimal since patients only need to
wear the watch and receive standard care according to the existing E-health
care pathway.
- Side Effects:*No significant side effects or physical risks are expected from
wearing the Corsano CardioWatch 287-2. The technology, such as
photoplethysmography (PPG), uses low-energy green light which does not cause
skin damage.
- Psychological Burden: There is no indication of psychological discomfort for
the participants as the intervention is non-invasive and requires no additional
medical procedures.