Parkinson Smartwatch Cost and Efficacy Study

Parkinson Smartwatch is an electronic diary for management of pharmacokinetic
fluctua-tions in movement disorders like Parkinson*s disease.
Levodopa is the most effective medicine for treating the symptoms of
Parkinson*s disease. Because of short half-life (each pill only works for a few
hours) most people take levodopa a few times a day. The timing and dosage of
pills is crucial for staying OK in more advanced stages, to prevent
fluctuations. If symptoms fluctuate, for example good hours alternating with
either stiff and slow hours or periods with too much movement, then adjustments
to the treatment schedule may help significantly.
For the optimal treatment of Parkinson*s the level of levodopa in the blood
should stay within the so called therapeutic window. To manage this, a doctor
needs to know when and how symptoms change during the day, so called response
fluctuations.
That*s where an electronic diary like the Parkinson smartwatch can help to keep
track of fluctuations. Whenever a change in condition is noticed, a patient can
easily record this using the *Status Rainbow*.
Simply touching the color on the smartwatches *Rainbow* (a semicircular visual
analog scale) records the (subjective, perceived) status: yellow means *off* or
*bad* (slow, stiff, tremor etc.), green is *good*, and red is for involuntary
movements.
The event of taking pills or eating a meal is also recorded in the electronic
diary with the simple touch of an icon at the watch. (Meals can reduce
gastrointestinal uptake of levodo-pa).
The information recorded at the watch is then sent to the Cloud where it is
stored securely. Smart charts of the data can be viewed on a personal, private
Parkinson Smartwatch webpage. The charts are designed to provide a doctor with
useful information to adjust the treatment plan. The webpage is accessible from
anywhere using either a computer, tablet, or mobile phone.
On a personal Parkinson Smartwatch webpage, charts comprise the data recorded
on the watch.
The charts indicate when pills and meals were taken. Different colours (on the
charts) show how the status changed from one hour to the next. The smartwatch
is also capable of au-tomatically gauging how much someone moved, from
accelerometer data, in a global sense (an RMS algorithm, comparable to a VU
meter for sound volume).

Parkinson Smartwatch also helps to take medicines correctly: at individually
specified times a reminder will appear on the watch with a self-chosen photo,
e.g. personal medication. This will assist taking the right pills at the right
time.

Primary Objective: to study the feasibility, effectiveness and user experience
of the Parkinson smartwatch in Parkinson patients with response fluctuations
(with dyskinesia).

Secondary Objective(s): to study the effect on cost, by monitoring the number
of patients who require advanced therapies like DBS (deep brain stimulation) or
a pump (levodopa gas-trointestinal gel or apomorphin).

Claims and intended performance to be verified:
- Parkinson Smartwatch is feasible: low dropout rate
- Parkinson Smartwatch is functioning without problems in a clinical setting,
as measured by user satisfaction and an inventory of problems, wishes and
suggestions
- Parkinson Smartwatch is cost-effective: the number of patients who need
advanced therapies after 12 months treatment is low compared to historical data
- Parkinson Smartwatch improves quality of life

Open One-Group Pretest-Posttest Design (O1 X O2). All patients will (have the
possibility to) use the Parkinson smartwatch for 12 months, in a home-setting.
Questionnaire forms are presented after the first week, at 6 months, and in the
last week, also to their doctor. Doctors are asked to use the data recorded on
the Parkinson smartwatch to optimize pharmacotherapy.

to use the Parkinson smartwatch for 6 months

1 Allergy for the strap or the case of the watch: Low Acceptable risk,
mitigated by instructions to remove the watch in case of skin irritation or
redness
2 Data validity issues: Low Acceptable risk, mitigated by instructions
3 Data integrity issues: Low Acceptable risk
4 Battery issues (empty, leakage, explosion): Low Acceptable risk
5 System availability (cloud dysfunction): Low Acceptable risk
6 Reminder dysfunction: Low Acceptable risk, mitigated by instructions