Pediatric Crohn's Disease Clinical Trial
Official title:
Mission is Remission®: How Can a Disease Self-management Website Change Care?
Crohn's disease and ulcerative colitis, known together as inflammatory bowel disease (IBD), are chronic inflammatory conditions of the gastrointestinal tract. Impacts of IBD such as frequent hospital visits, need for surgery and poor growth, can significantly impact a child's social and academic life. Dealing with a chronic disease forces children to rely more heavily on family members for coping strategies to deal with stress. However, a lot of families do not have the resources (emotional or financial) to provide the level of support needed. A self management site called Mission is Remission® has been created to help adolescents and their families deal with the stressors associated with their disease. The site provides a supportive social network that is centred around learning sessions and active forums discussing topics related to disease self-management and coping. This site actively brings together members of the healthcare team and provides support to families who might not be able to travel for additional appointments outside of routine care. The goal of our research is to understand whether the changes this social support will increase disease-specific knowledge, medication adherence, and health-related quality of life. We will also examine whether these changes may reduce some of the demands placed on the Health Care system (e.g., reduced number of calls and visits to gastroenterology (GI) doctors, or time lost from school/work). In addition, this website has been designed to be adapted in the future to other chronic diseases and will help bring healthcare into the digital age.
Background How do health care professionals help children, help themselves? How do patients
become active participants in their own care? The prevalence of chronic conditions, such as
IBD, is increasing in Canada [1, 2]. Health care systems need to look for sustainable and
effective solutions to improve patient care while reducing health care costs. Crohn's disease
(CD) and ulcerative colitis (UC), known collectively as IBD, are chronic relapsing and
remitting diseases associated with significant medical (i.e., number of hospitalizations,
frequent need for surgery, growth failure) and social (i.e., school absences, interference
with pursuit of higher education) morbidity [3]. Medical and social morbidity of IBD are
intertwined, and take a significant toll on the health-related quality of life (HRQOL) of
these patients [4-6].
IBD manifests during childhood or adolescence in 20% to 25% of patients [7]. This is a
crucial time in children's development, both physically [8] and emotionally [9]. Children's
relationships with family and peers change significantly over the course of their childhood.
Normal social development sees children seeking more emotional support from peers over family
members in their adolescent years [10]. However, adolescents with IBD do not follow this
pattern [11] and tend to seek continued support from family members and rely on parents'
coping strategies to deal with stressors [12]. With increased reliance on family support when
dealing with a chronic illness like IBD, children may be faced with additional burden when
their parents' are not able to offer them the emotional support they need or do not have
coping skills that are effective enough to translate into increased care for their children.
Despite this, no interventions (to the authors' knowledge) to benefit psychosocial
functioning have been specifically studied in pediatric patients or families with IBD.
Current medical intervention tends to focus exclusively on the disease, and does not focus on
disease management and coping through self-management skills. Disease self-management
involves ―the interaction of health behaviours and related processes that patients and
families engage in to care for a chronic disease‖ [13]. Studies in both the adult and
pediatric chronic illness literature have shown that comprehensive interventions that augment
medical treatments with self management therapy, lead to better medical outcomes and better
quality of life than care that is strictly medically focused [4-6, 14-24]. These
self-management studies are focused on chronic diseases such as diabetes, asthma and
rheumatoid arthritis. There have been several small studies of psychological interventions in
adult IBD patients with promising results, though issues with design limited the
interpretation of the results [25-28]. Disease self-management is more than simple adherence
to treatment guidelines - it also incorporates psychological and social management of living
with a chronic illness.
―It's something the investigators know intuitively, but it's also supported by evidence: A
child's living conditions and experiences - the determinants of health - shape his or her
physical health, development, and well-being, affecting not only childhood but the foundation
of their health as adults [29, 30].‖ (Stepping it up Report, pg. 23, Health Council of
Canada).
Children's experiences (i.e. access to services), can be directly affected through disease
self-management. Self-management training is often provided by tertiary care clinics, which
includes disease education, and encouragement/support, usually at the time of diagnosis. Most
care is given in concentrated sessions during crises times and is in response to a particular
problem, which is not the best time to teach self-management skills. Families who are
extremely distressed may, in rare cases, receive formal psychological therapy. Although most
families receive excellent medical care in the tertiary care centres, the vast majority of
patients do not receive comprehensive disease education and self-management therapy. Very few
children with IBD receive comprehensive education and self management therapy even when they
attend well organized tertiary care clinics.
Geographic and financial concerns often limit access to psychosocial care and information
sessions. In most areas of Canada, psychosocial treatment is available through private care.
Psychosocial treatment is available for free through public institutions (Canada Health Act,
1984); however, there are long waiting lists and significant time and financial-costs to
patients. Parents would have to travel and take time from work, while children would miss
school and other related activities, which may further prevent access to treatment. Many
families are reluctant to see a psychologist, social worker or psychiatrist due to the social
stigma attached to seeking psychotherapy. For some families, the entire process is perceived
as blaming them for their problems [31].
In the past 20 years, treatments aimed at teaching parents and children to change their
attitudes or behaviour have been developed and evaluated by means of rigorous, randomized
trials [32-41]. Although there is strong evidence that these psychosocial treatments work in
reducing symptoms and increasing health related quality of life (HRQOL), they are typically
delivered only in specialty clinics by highly trained personnel. Few therapists outside of GI
clinics will be knowledgeable enough about the disease to effectively help patients and
families integrate their psychological and medical care. Evidence from a large meta-analysis
has shown that many self-management treatments can be given with as good or better outcomes
by paraprofessionals following evidence-based protocols [42]. The use of web-based programs
to deliver self-management care has taken off in recent years. Recent meta-analyses have
found improved behavioural outcomes for adults using web-based self-management programs [43]
and improvements in symptom and disease control for youth with health conditions [44].
Web-based interventions have been found to be comparable to face-to-face treatments [45], and
have demonstrated increased social support when programs utilize chat rooms. As Stinson et
al. [44] state, many studies have not been able to determine the durability of treatment
effects or the cost-effectiveness of these programs. The current research will attempt to
address some of these shortcomings.
Based on the lack of access to disease-specific care outside of existing medical
intervention, the Mission is Remission® web-based intervention program was created in 2005 as
a pilot study, for use by IBD patients and their families. This is a web-enabled evidence
based home program of self-management, information, and social support for pediatric IBD
patients aged 12-18, with a separate site for their parents. The site was accessed on a
restricted-access web site, and participants worked through the program with help of a coach.
The coaches worked in collaboration with gastroenterologists, nurses and a psychologist, but
the coaches were not medical professionals. This served as an adjunct to routine medical care
but not as prescribed medical therapy by the patient's physician or team. This
individualized, interactive 12 session program incorporated multi-media tools for disease
education and psychological interventions.
The previous research program enrolled two groups of patients—those with inactive disease and
those with active disease, and their parents [46]. Remission was induced in patients with
active disease before beginning use of the Mission is Remission® site. Although participants
demonstrated improvements in main outcome variables such as HRQOL, and Disease Knowledge,
there was no true control group in this study such that statements around the effectiveness
of the program in comparison to routine or standard care could not be made. Based on lessons
learned from the first Mission is Remission® site, a new site was created, which was made
possible from an IWK Auxiliary Grant. The expertise of the web-developer, who has been
involved in the development of multiple sites for teens, was pivotal in guiding the site's
development. The use of social networking, peer support, and parent-to-parent support was
optimized through this process.
The proposed research plans to randomize patients to receive either comprehensive care using
the Mission is Remission® site or to receive routine care (i.e. regular hospital clinic
visits, appointments with clinicians and other specialists as required).
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