Study of the cost-effectiveness of fatigue management in patients with Crohn*s disease (CD)
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aims of study:
1. The primary aim of the study is to assess the cost-effectiveness of a
fatigue coping course in patients with CD.
2. Secondary aims are: improvement of fatigue and quality of life through the
introduction of this specific coping strategy in IBD patients.
Secondary outcome
see above
Background summary
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.
Study objective
Study of the cost-effectiveness of fatigue management in patients with Crohn*s
disease (CD)
Study design
Prospective, cross-over intervention study in CD patients
Intervention
Subjects scoring high on the CIS compared to a healthy norm population (9th
percentile) will be included for the intervention study. Patients randomized
for a fatigue coping strategy will receive a course to learn to cope with
fatigue. Control subjects will receive standard care. The training is based on
the Problem Solving Therapy (PST) or Solution Focused therapy.
PST is a frequently used hands-on psychological intervention based on a general
model of coping with stress. This model assumes that a chronic disease causes a
number of stressful problems in daily living. These stressful problems increase
the chances that the patients become anxious and depressed. The treatment goal
of PST is to increase the capabilities of the patients to deal with the daily
stressful problems caused by CD. In this way the anxiety and depression would
be reduced. This method has been validated and shown to be successful in other
patient groups with chronic diseases. For the purpose of this study the PST
will be modified to focus on fatigue management (PSTF). The training is done in
10 group sessions during 3 months, and the patients have to do *home work* in
between.
Another psychological intervention is Solution - Focused Cognitive Therapy
(SFCT). SFCT is a brief hands-on 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. 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 SFCT
will be modified to focus on fatigue management (SFCTF).
Study burden and risks
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.
s Gravendijkwal 230
3015 CE Rotterdam
NL
s Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
patients, older than 18 years, have to be in remission according to the investigator, based on accepted clinical parameters and medical records (CDAI< 150 and CRP< 10, or at endoscopy).
Exclusion criteria
pregnancy or breastfeeding; subjects likely to require emergency surgery and subjects who have undergone bowel surgery within 3 months prior to this study. Subjects with a short bowel syndrome; with a neoplastic condition; with a history of clinically significant and/or persistent gastrointestinal disorder (other than CD, for example IBS), underlying psychiatric disorder (depression/anxiety disorder).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL22792.078.08 |