Resmon Pro Diary Pilot Study - Evaluation of Vivisol Service to remotely prevent COPD exacerbations

The Netherlands has a high burden of Chronic Obstructive Pulmonary Disease
(COPD) due to premature morbidity, loss of healthy life years, high mortality
and high economic and societal costs. During the course of the disease it may
happen that a general deterioration with an increase in symptoms occurs. This
usually occurs due to a respiratory infection. This exacerbation can be
characterized as mild, moderate or severe.
The exacerbation can lead to hospitalization. A severe exacerbation can have a
slow recovery, may lead to a permanent impairment or decrease in FEV including
a decline in QOL. In addition to these negative effects on the patient,
exacerbations also increase the costs for the society. It is therefore of
utmost importance to detect a possible exacerbation at an early stage so that
with a timely intervention it is possible to avoid hospitalization.
Thanks to the Resmon Pro Diary it is now possible to early detect patient
worsening, giving the physician the possibility to act efficiently in order to
avoid the exacerbation or reduce its severity. It consists of a unit that is
placed at the patient home, a 3G sim card and a data server that communicates
with Vivisol.
Resmon PRO Diary is a device with which no treatment is given, it is intended
to monitor remotely COPD patients at home. Patients do not have to perform
forced maneuvers. The patient only has to breathe through the device for 15
normal respiratory acts. The device automatically discards cough events and
incorrect breaths. No supervision is needed after the first training. No risks
or adverse effects were observed in previous studies.

This pilot does not aim to demonstrate the effectiveness of the system. The
effectiveness of the system has been demonstrated in the recently published
study: Chromed study, a multi-center Randomized Controlled Study.
This pilot aims to obtain information about how Vivisol's service with the
Resmon Pro Diary is experienced in Dutch practice, by both the clinician/
health care providers and patients.

The study can be divided in the following steps:
1. The Hospital selects 3 COPD patients fulfilling the inclusion criteria.
2. The patient receives the outpatient information about the pilot study and
signs an informed consent.
3. The patient is visited by Vivisol at home and hereby receives a Resmon Pro
Diary.
4. Patient signs an agreement that Vivisol can monitor the data from the Resmon
Pro Diary via telemonitoring.
5. Patient breathes normally every day for 15 respiratory acts in the Resmon
Pro Diary. The test need to be done every day at the same time, for example
before taking any medications.
6. The patient will respond to a questionnaire 3 weeks after the beginning of
the pilot and again during the 3rd month of the trial. THe physician has to
fill out a questionnaire 3 months after the start of the trial.
7. After 12 months, the pilot is terminated and Vivisol retrieves the Resmon
Pro Diary.
8. At the end of the pilot the patient and physician has to fill out a brief
questionnaire .

Three hospitals will be selected to participate in this pilot study. Each
hospital will select 3 patients for this pilot study. The 9 patients will be in
the study for 12 months.

Patients have to breath normally in the Resmon Pro Diary 15 times a day.
Vivisol will monitor the patient daily form a distance and will inform the
physician as soon as the Resmon Pro Diary predicts an exacerbation. The
physician is responsible for further follow-up with the patient.

Burden for the patient:
- Daily breathing in the Resmon Pro Diary (15 breaths - 90 seconds every day )
- 3 questionnaires (total 10 minutes)

Risks: none