Role of a Web-Based Interactive Patient-Professional Support System (WIPPS) in the adherence of the Novel Oral Anti-Coagulants: a randomized controlled trial.

With the arrival of new oral anticoagulants - i.e. oral factor Xa inhibitors
and oral factor IIa (thrombin) - a new era for patients with an increased risk
for thrombosis is emerging. However, the advantage of the new oral
anticoagulants, which need no regular evaluation of the therapeutic range,
could also be its disadvantage since regular pills for chronic use are prone
for lack of adherence with a major impact on thrombo-embolic complications.
This concern is based on the fact that lack of adherence is a common problem.
Adherence rates are typically lower among patients with chronic conditions, as
compared to those with acute conditions. Persistence among patients with
chronic conditions is disappointingly low, dropping most dramatically after the
first six months of therapy. Common causes for lack of adherence that are
patient based, are forgetfulness and having other priorities. Reasons for
conscious decisions to omit doses are mostly based on false interpretation of
the benefits and risks (side-effects) of taking the medication, due to lack of
information and emotional factors. Common health care barriers are poor excess
to as well as poor interaction with the professional. A review of the
literature shows that most methods of improving adherence have involved
combinations of education (information about the patient*s condition and the
treatment) to increase awareness and motivation, enhancement of self efficacy
with structured and stepped behavioural interventions and empowerment by
feedback, supervision or attention. To be more specific the methods that can be
used to improve adherence can be grouped into four general categories: provide
patient education; keep the intervention / dosing schedule as simple as
possible; provide optimal increasing the hours when contact with a physician is
possible; and improved communication between physicians and patients and
educational interventions. Enhancing communication between the physician and
the patient is a key and effective strategy in boosting the patient*s ability
to follow a medication regimen
Successful methods are complex and labour intensive when not using ICT
solutions, thus innovative strategies that are practical for routine clinical
use must be deployed. E-health support plays an increasing role in the
treatment and dose advising of the current VKA treatment.
The above-mentioned relevant measures of increased adherence are all
incorporated in a currently successfully implemented model for VKA treatment.
In this approach patient education is supported by e-learning. With 16 hour a
day 7 days a week on-line service the hours that a physician can be consulted
are increased with a low threshold form of communication between physicians and
patients,
Forgetfulness is contested by sending SMS and e-mail reminders.
Data from a regional Dutch healthcare insurance company on WIPPS in VKA
patients showed a trend that there was less bleeding and thrombosis
complications in this group of patients as compared to *usual care*- VKA
patients (matched for age, gender, postal code etc.), suggesting improved
compliance in the WIPPS group.

NOACs have no need for regular monitoring, this could have an effect on
adherence. It is our objective to study adherence and patient satisfaction in
WIPPS guided and non-WIPPS guided patients using Rivaroxaban

This is a randomized controlled trial comparing one arm receiving usual care
with thee second arm receiving guided care by a Web Based Interactive
Patient-Professional Support (WIPPS) system. The follow up durations will be
one year.

Every patient receives a satisfaction questionnaire at the beginning and the
end of the study.
In addition, patients randomised to the WIPPS arm have to complete an
e-learning on atrial fibrillation and anti-coagulation and the software used in
the study, followed by an exam which they must pass before they can continue
with the study. After passing the exam, the intake visit takes place where the
satisfaction questionnaire is taken. Once entered in the study patients
randomised to the WIPPS arm also have to report a status update every two
weeks. The e-learning is repeated every six months.

With the arrival of new oral anticoagulants - i.e. oral factor Xa inhibitors
and oral factor IIa (thrombin) - a new era for patients with an increased risk
for thrombosis is emerging. However, the advantage of the new oral
anticoagulants, which need no regular evaluation of the therapeutic range,
could also be its disadvantage since regular pills for chronic use are prone
for lack of adherence with a major impact on thrombo-embolic complications.
Therefore, in the current study we investigate the potential beneficial effect
of guided care WIPPS on the adherence in patients receiving Rivaroxaban AF,
which is an indication for lifelong anticoagulation therapy.
The burden of this study is low. WIPPS guidance is non-invasive, and mainly
consists of a brief online questionnaire which only takes a few minutes to
complet once every two weeks. The benefit is a potential increase in adherence,
which is likely to result in less thrombotic complications.