The cost-effectiveness of fatigue management in patients with Inflammatory Bowel Disease (IBD)

Background: Inflammatory bowel diseases (IBD) are chronic inflammatory
conditions that can affect the entire gastro-intestinal tract. IBD is still
divided into 2 subcategories: Ulcerative Colitis (UC) and CD. Annually, 1400
patients with IBD are visiting the IBD out-patient clinic in the Erasmus MC.
The average frequency of these visits is twice a year but this frequency rises
to once per month in about 60% of patients. Reasons for increased frequency of
visits are: relapse of the disease, side-effects of medication, and fatigue. It
is known that about 41% patients with quiescent IBD (UC and CD) suffer from
fatigue .They often score their symptoms similar to what is reported by cancer
patients.The fatigue has a high impact on the quality of life, and leads to low
employment and high disability rates. The costs related to IBD consist of
direct costs (32%; inpatient care, outpatient care, self-care, medications and
tests/procedures) and productivity costs (work absence, decreased incomes,
premature death and decreased health related quality of life (HQoL). The direct
costs vary between 6.000 euro- 40.000 euro per patient year, and are expected
to be higher in IBD patients with fatigue than in those without, as shown
previously in IBS patients. Fatigue may result in a defensive and ineffective
use of medical attention and resources and therefore to more frequent visits,
more tests and often variable treatment. If an effective treatment would be
offered to deal with the fatigue, this would redirect the medical attention
seeking behaviour of the patient, and could result in a more cost effective way
of treating these patients. No studies specifically aim to treat IBD patients
with fatigue have been performed so far.
Furthermore we aim to explore the mechanisms which lead to fatigue in IBD
patients because of the lack of knowledge on the pathogenesis of fatigue. We
hypothesize that the ongoing inflammation in the gut plays an important role in
the pathogenesis in fatigue even in IBD patients in remission and on medical
therapy, which can be determined by different cytokine levels. Increased levels
of the anti-inflammatory cytokine TGF-beta have been detected in sera from
patients suffering from Chronic Fatigue Syndrome (CFS). Interestingly this
cytokine is also increased in sera of IBD patients in clinical remission.
Another study showed that endotoxin-stimulated ex vivo production of tumor
necrosis factor-alpha and IL-beta was significantly lower in CFS compared to
healthy controls. The question remains whether this effect was the result of a
shift in leukocyte subpopulations or defective function of the TNF/IL-1b
producing cells. Other studies demonstrated increased leucocyte apoptosis of
which one study pointed this phenomenon down to the neutrophil population. The
latter also showed that neutrophils from CFS expressed more TNFRI death
receptor molecules. Together these data show that there is evidence for
involvement of the immune system in patients suffering from chronic fatigue.
Therefore we will measure a wide variety of cytokines known to be involved in
IBD before, during and after the psychological intervention. We will measure
these cytokines in fatigue patients, in fatigue controls waiting for the
intervention and in non-fatigue controls with IBD.

Study of the cost-effectiveness of fatigue management in patients with Crohn*s
disease (CD) and Ulcerative Colitis (UC)

Prospective, cross-over intervention study in CD and UC patients

The training is Solution - Focused Cognitive Therapy (SFT). SFT is a brief
psychological intervention based on the solution - focused model of solving
problems.
Although problems, in this study caused by CD, can be overwhelming, there are
always moments when the problem is not there or when the problem is less severe
or slightly different than at other times. In other words, there are always
exceptions to the problems. These exceptions interest the solution - focused
therapist because they indicate that there are partial solutions that can be
enlarged into total solutions. Even amidst the worst possible mess there are
always things to be found that still work or can be made to work.
Solutions belong to the future while problems belong to the past. The solution
- focused model offers a wide range of interventions that channel your
attention towards constructing possible solutions. Instead of concentrating on
the (why of the) problems in the past, the solution - focused model
concentrates on the desired outcome.
The method has been empirically validated and shown to be successful in other
patient groups with chronic diseases. For the purposes of this study the SFT
will be modified to focus on fatigue management (SFT).

The training is done in 7 group sessions during 3 months, and the patients have
to do *home work* in between. The Solution - Focused Principles:
1. If it*s not broken, don*t fix it.
2. If something is working, do more of it.
3. If it is not working, do something different.
4. Small steps can lead to large changes.
5. The solution is not necessarily directly related to the problem.
6. The language requirements for solution development are different from those
needed to describe a problem.
7. No problem happens all the time. There are always exceptions that can be
utilized.
8. The future is both created and negotiable.

Study Rationale and Relevance to IBD patients: IBD patients are suffering from
a disabling chronic disorder which affects their daily lives negatively. A
large group of this patients experience extreme fatigue which leads to a lower
quality of life. Often no active disease is underlying this fatigue and no
treatment options are available in improving this fatigue and subsequently
their quality of life. This study is not aiming at finding the underlying
pathogenesis of fatigue, however is designed to improve the coping of fatigue
in IBD patients and aims to lower health care costs due to this intervention.