(Cost-) effectiveness of a Multi-Component Intervention for adults with epilepsy: a Dutch randomized controlled trial

HEALTH PROBLEM
Epilepsy is a neurological disorder characterized by recurrent unprovoked
seizures. Seizures are the result of sudden, excessive electrical discharges in
a group of brain cells. The clinical manifestations of seizures will vary and
depend on where in the brain the disturbances first start and how far they
spread. Transient symptoms can occur, such as loss of awareness or
consciousness and disturbances of movement, sensation, mood or mental function.
Recent studies have shown that up to 70% of newly diagnosed children and adults
with epilepsy can be successfully treated (i.e. completely controlled) with
AEDs. In summary, epilepsy is a large societal problem, which can, in the
majority of the patients, be treated successfully with AEDs.
The prevalence of epilepsy treated with anti-epileptic drugs (AEDs) is about
5.15 per 1,000 people. For the Netherlands this implies that currently about
80,000 patients are treated with AEDs. The Dutch health care costs for epilepsy
are ¤221 million 3. This is comparable to the cost in other western
countries.Next to that, productivity losses account for the largest part of the
total costs of epilepsy.

CONCORDANCE IN EPILEPSY
Concordance to AEDs is a health issue of major relevance in patients with
epilepsy. Haynes (2008) even argued that *Increasing the effectiveness of
adherence interventions may have a far greater impact on the health of the
population than any improvement in specific medical treatments*.Patients with
uncontrolled epilepsy heavily depend on informal care (family and friends) and
health care professionals (neurologists, nurse practitioners, nurses, social
workers, psychologists etc.).
Complications due to epilepsy result in frequent hospitalizations. Growing up
with seizures affects the patient*s personality and interferes with many
aspects of everyday life including schooling, leisure and occupational
activities. People with epilepsy are often confronted with reduced access to
health and life insurance, a withholding of the opportunity to obtain a driving
license, and barriers to enter particular occupations, among other limitations.
In summary, non-adherence to AEDS will have a huge impact on the patient and to
the society as whole.

MULTICOMPONENT INTERVENTION
The Mullticomponent intervention (MCI), which combines a
self-management/education program with eHealth interventions (apps and
Medication Event Monitoring System) aiming to improve self-efficacy, and thus
adherence to AEDs.
Several studies in other chronic diseases, such as hypertension and diabetes,
have shown that a MCI can be efficient in increasing concordance. In the field
of epilepsy, scientific evidence that a MCI is effective and efficient is
lacking. Due to several reasons the results of the other studies relating to
chronic patient groups, cannot be generalized to patients with epilepsy. One
reason is that the consequences of not taking AEDs are not always time related;
seizure deregulation can appear the same day or a couple of days later. So for
patients the direct link to taking AEDs and the frequency of seizures is not
transparent. There are also no direct quantitative measures for the
consequences of non-adherence as there are in hypertension (blood pressure) or
diabetes (blood sugar level). As a result, patients with epilepsy cannot
directly monitor the influence of concordance. Finally, AEDs causes side
effects in 88% of the patients, leading to non-adherence to AEDs. As a result,
it is of major importance to study the effectiveness and efficiency of an MCI
in the group of epilepsy aimed at stimulating concordance to AEDs.

The overall objective is to assess the (cost-) effectiveness of MCI
(self-management/education program & e-health) aiming to improve self-efficacy
and adherence in people of with epilepsy compared to care as usual (CAU).
The study consist of 3 parts
PART 1. CLINICAL EFFECTIVENESS
PART 2. ECONOMIC EVALUATION
PART 3. PROCESS EVALUATION

A pragmatic randomised controlled trial (RCT) in 2 parallel groups will be
conducted that compares the MCI intervention with a waiting list control
condition, which reflects CAU as naturalistically as possible. One hundred
epilepsy patients will be recruited from the centre for epilepsy Kempenhaeghe.
Subjects who are involved in the study will be followed for approximately 12
months for the intervention group and 6 months for subjects in the CAU control
group.

MULTICOMPONENT INTERVENTION
The components of the MCI are methods of enhancing self-management skills &
usages of different eHealth tools, which can be used to (self) monitor their
condition.

Group sessions
The MCI intervention will last 9 weeks. During the first 5 weeks group sessions
will take place. Followed 4 weeks later by a booster session.
The first session is aimed at providing information about the course, including
materials, and to get to know the other participants and therapists. During the
next sessions participants will practice with the 5-step model (Aspinwall &
Taylor) and three fixed themes. 19
The first theme is self-monitoring and self-monitoring (eHealth) tools. The
last two themes will be risk-management and shared decision-making. The group
sessions will have the same basic structure. The start will always be looking
back at the goals set in the previous meeting and how that worked out in the
last week. Then the theme of the session will be introduced. Patients and
caregivers will be invited to share their beliefs, emotions and experiences
with regard to the theme. Subsequently, patients and caregivers will formulate
their own action plan in order to attain a goal relevant for the theme. The
goals will be limited and feasible and caregivers are stimulated to select
their own goals. Group members will give feedback on the quality of the goals
in terms of concreteness and attainability. They will help each other to
recognize additional conditions and barriers which need to be addressed. After
the feedback discussion, patients and caregivers will formulate their final
plan in a SMART-form (i.e. what are they going to do, how, when and where).
The group sessions last for 2-2,5 hours and 4-6 patients with their possible
caregivers will be present (total 4-12 participants). The group sessions are
led by a nurse practitioner, with experience in working in groups and with
epilepsy patients.
The eHealth tools used in the intervention consists of 3 elements; 1) the
Medication Event Monitoring System (MEMS), 2) a smart phone app 20 3) an
internet accessible patient database. The Medication Event Monitoring System
(MEMS) (AARDEX Ltd., Switzerland) operates as follows; MEMS caps are electronic
caps that fit on standard pill bottles. They register date and time of every
opening of the pill bottle, and the data can be downloaded from the MEMS cap
with a communication device and a computer. The Powerview software presents the
data in simple plots. These plots can be used to provide feedback about
behaviour, and to identify suboptimal adherence patterns.21 The smart phone
contains a special smartphone application (app) for persons with epilepsy in
order to register seizure frequency and other facts, which can influence the
condition. Information gathered this way can be used through a website
application, to provide feedback for a shared decision making process with the
health care professional.20

Booster session
During this session de nurse practitioner will rehearse the theory around the
5-step model. Patients and caregivers will have the possibility to discuss
their experiences related to their goals and other aspects of the course.

The nurse practitioners offering the MCI will receive training beforehand on
motivational interviewing (MI), as a technique to empower patients to set their
own sustainable goals and look into conflicting believes. The intervention will
be explained in a detailed protocol for the nurse practitioner and a workbook
for patients and caregivers.
Motivational Interviewing (MI) a client-centred counselling method will be
used. This counselling style, used by the group leaders, will help patients to
explore and revolve ambivalence and bring about changes in their behaviour.22

CARE AS USUAL
The control condition will be a waiting list control condition with
unrestricted access to CAU. As this will be a pragmatic trial, CAU will not
follow a standardised protocol. Medical support provided in the control group
might be variable but is expected to be in agreement with the
multi-disciplinary epilepsy guidelines.23
In (economic) evaluation studies preferred as naturalistic in comparison with
real situation

Next to the investment in the programme there are no disadvantages by
particating in this study. There are no risks.
The possible positive results from the Multi component intervention (MCI) are,
subjects
1) will receive information about epilepsy and the use of eHealth-tools, 2)
have contact with peers and health care professionals, 3) have a forum to
discuss their feelings, cognitions and experiences with others and 4) have a
(possibly) shared activity with their caregiver and. The subjects of the CAU
control group will receive the same intervention after T2 (6 months).There are
no known risks for subjects participating in this study.
Their are no risks