Remote patient Monitoring in adults receiving red blood cell Transfusion for hematological disorders * a Pilot study of the physIQ Real World Monitoring platform using wearable biosensors

Patients with haematological diseases receive more than half of the total
volume of transfused red blood cells (RBCs) in The Netherlands. Apart from
prediagnostics, storage and transportation, the total costs for RBCs for this
group are about 60 million euros a year. In spite of these costs, there is a
lack of evidence to support a specific or optimal transfusion strategy.
Adverse events of RBC transfusions, like transfusion reactions, iron overload
and poor clinical outcomes in studies with a liberal transfusion thresholds are
reasons for considering a restrictive transfusion strategy.
One parameter for determining transfusion timing could be the patient vital
signs and activity. Measuring decrease in activity/detoriation in vital signs
due to chronic anaemia and subsequent gain in activity/vital signs after RBC
transfusions objectively through continuous vital parameter measurements, with
a device like PhysIQTM*s VitalPatch®, is therefore of vital importance to be
able to create evidence-based guidelines on when and how to transfuse as
restrictively as possible without compromising quality of life(QoL).
Effectively determining this would mean a lower transfusion rate and a
significant decrease in healthcare costs. Furthermore, we are interested to see
whether transfusion and transfusion-induced changes in vital signs/activity
change QoL and cognition, and whether data derived through the pinpointIQ*
system could be used to indicate the need for transfusion. Lastly, we want to
assess whether data captured by a Withings Steel Smartwatch is as usable as
that captured by the VitalPatchTM, for possible improvement of wearability in
the future.

Primary objectives:
- to explore transfusion induced differences in vital (activity) parameters
such as heart rate, respiratory rate and activity before and after RBC
transfusions in regularly transfused patients using the pinpointIQ* system.
- To find a significant difference in mean heartrate per day before and after
transfusion, large enough in comparison to the standard deviation of the mean
to power a study with a reasonable sample size.

Secondary objectives:
- compare the transfusion induced effect on vital signs to the number of
transfused units;
- assess correlations between biosensor data and patient-reported physical
function collected via ePRO;
- in case of a transfusion reaction: capture vital signs during the transfusion
reaction using the pinpointIQ* system;
- compare data collected by the VitalPatch® and the Withings Steel Smartwatch;

This is an observational single-arm open label pilot study in which 5 patients
will be enrolled.

Risks: Possible irritation of skin at placement site of VitalPatchTM or at the
wrist.

Burden: Patients wear a VitalPatch® and a Smartwatch for 28 days and a second
smartwatch for 7 days, fill out an eight-question PROMIS short form 14 times,
complete a 33-item QUALMS-questionnaire 5 times and complete a 5 minute
cognitive CANTAB tool 5 times.

Benefits: continuous monitoring which allows for a quick reaction to serious
adverse events; possible improvement of QoL due to patients knowledge that they
are being monitored; the VitalPatchTM will free up time for the clinician and
nurse and provide flexibility when to see a patient, in case time-specific
traditional measurement of vital signs (at the bedside) is no longer required.