Telemonitoring and connected care applied to Multiple Sclerose: Effect on quality of life

Multiple sclerosis (MS) is the most common neurological disease (1: 500-1000)
by young adults. It leads to permanent disability and has a profound impact on
all aspects of human functioning. This disease includes comprehensive fatigue
and often cognitive problems that negatively affected on quality of life, which
also has a negative effect on the consultations in the hospital.
It is important to ensure the patient*s autonomy from the start of diagnosis
but also when limitations increase and someone becomes more dependent.
You only get autonomy if you have sufficient, objective, knowledge to make
appropriate choices yourself.
Self-management can contribute to an increase in knowledge about one's own
situation and illness, which, among other things, increases adherence to
therapy.

MS cannot be cured. However, new treatments have become available in recent
years. These are much more effective (slow down or even stop MS) but also have
more side effects and are more expensive. Careful monitoring based on effect
and side effects is therefore important. The consequence is a high frequency of
hospital visits and a great burden for the patient. This great burden manifests
itself in an increase in the fatigue and cognitive problems that are already
present, as a result of which the consultation in the hospital provides less
information and is less efficient than desired.

In this research we work with three applications: MSmonitor (MSM),
*Beterdichtbij* (video-calling) and the Research Manager

MSM has been specially developed by MS neurologists for MS patients. With this
program, MS patients can keep track of their signs and symptoms and share them
with an MS neurologist and nurse specialist. With the application
*Beterdichtbij*, MS patients can make video calls to the MS neurologist or
nursing specialist.

All MS patients actively receiving treatment within Isala are eligible for this
study. It is randomized, comparing home monitoring (working with MSmonitor)
with standard treatment.

One group (104) continues with the standard treatment (consultations at the
clinic). The remaining group (104) will perform home monitoring with MSmonitor
(MSM) and will start video calling. In this group, 50% of the consultations
will be replaced by video calling.

Both groups complete questionnaires every 3 to 6 months via the Research
Manager application (= online research program) during the research. These are
about general health, MS, care consumption, self-management, autonomy and
quality of life.

The informal caregivers of MS patients are also involved in this study. When
participating, they complete questionnaires that relate to the care they
provide to the MS patient and the cognition of the MS patient.
Questions are also asked about the informal caregiver, such as his or her
economic and social situation. The informal caregivers also use the Research
Manager application to complete the questionnaires in a separate account

The primary endpoint (equal or improved MSQoL-54 and Eq5d) at which the value
of telemonitoring is determined is t = 2 years.

Mapping the effects of digital consultations or hospital visits, for MS
patients, informal carers and the Isala hospital

Based on the results of this study, we will look at whether we can optimize
personal care for MS patients while maintaining the safety and quality of care.

Investigate whether home monitoring and video calling reduce the check-up
frequency in the hospital, so that the quality of life remains the same or
increases.

Investigate whether the use of MSM increases the autonomy of the MS patient.
(IPA)

Investigate whether the self-management behavior of the MS patient improves by
using MSM. (PIH)

Investigate whether the use of telemonitoring and video calling makes the
consultation more effective compared to standard care ( less medication
changes, fewer hospital admissions MS)

Single center, prospective randomized clinical trial

1.6 Interventions for the research groups
1.6.1 Telemonitoring group
Patients in the home monitoring group will record developments / symptoms
related to their MS disease and general health by completing psychometrically
validated MS specific questionnaires, inventory lists and diaries in MSM. 50%
of the regular check-ups in the hospital will be replaced by video calling with
the nurse specialist/MS-neurologist. On indication, hospital checks may take
place more often or even less often, depending on the results of the
questionnaires in the MSM.
Prior to a check (physical or video calling), this group answers the
questionnaires that have been prepared in MSM. Preparing specific
questionnaires can also be done by the healthcare provider himself or herself,
if he or she considers it necessary.
Within this study, we will have each patient complete the same questionnaires
in MSM prior to a consultation with the neurologist or nurse specialist in
order to be able to make a good comparison.

1.6.2 Control group
For the control group, they receive standard care, through regular physical
check-up visits to the neurology clinic in the hospital and more often if
necessary. This group does not use MSM or starts video calling


Both groups (telemonitoring group and control group) complete questionnaires
through the program the research manager. The Research Manager is an online
research program. The times at which the questionnaires will be completed are
the same for both groups.


Informal carers
The informal caregivers of MS patients are also involved in this research. This
population is asked to complete a questionnaire (iMTA Valuation or Informal
Care Questionnaire) when participating at baseline and after that once a year.
This questionnaire is about the specific aspects surrounding the informal
caregiver. This group also completes the Carelqol every 6 months and to
complete the CFQ (Cognitive Failure Questionnaire) at baseline and every six
months, relating to the person who is being given informal care (MS patient)

There are no additional risks associated with this research. The care provided
to all MS patients participating in this study remains the same.
The quality and safety of care when using MSM is ensured by authorizing
caregivers to view and use the completed patient data.
Change in results are quickly visible to any healthcare provider. This means
there is double control over the course of the disease over time.
EDSS Score (Expanded Disability Status Scale) drug switching and clinical
admissions will be recorded every 3 months in the research manager. As a
result, a course of time can be seen of the most important values that register
any increase in disease activity.