Clinical Trial: Mission is Remission®: How Can a Disease Self-management Website Change Care?

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Mission is Remission®: How Can a Disease Self-management Website Change Care?

Brief Summary: 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.

Detailed Summary:

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 famil
Sponsor: IWK Health Centre

Current Primary Outcome:

• Questionnaire to Assess Self-Efficacy - Changes from baseline [ Time Frame: Baseline, 3 months and 6 months ]
  Adolescents will complete a questionnaire to assess self-efficacy. This will be done at three time points: baseline, 3 months into the study, and at 6 months (at the end of the study).
• Questionnaire to Assess Health Related Quality of Life - Changes from baseline [ Time Frame: Baseline, 3 months and 6 months ]
  Adolescents will complete the IMPACT-III questionnaire which is a health-related quality of life questionnaire for pediatric patients with inflammatory bowel disease. The questionnaire will be completed at three time points: baseline, 3 months into the study, and at 6 months (at the end of the study).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Medication Taking Behavior Questionnaire [ Time Frame: Baseline, 3 months and 6 months ]
  Adolescents will complete a"Medication Taking Behavior" questionnaire to look at medication adherence in this patient population.
• Questionnaire to Assess Disease Activity [ Time Frame: Baseline, 3 months and 6 months ]
  The Pediatric Crohn's Disease Activity Index (PCDAI) (Hymans, Markowitz, Otley et al., 2005) will be used to assess disease activity in study participants who have Crohn's disease.This measure assesses disease severity, based on subjective items (e.g, patients's report of abdominal pain, stooling pattern, general well-being) and objective data (e.g. weight and height). The Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007) will be completed to assess disease activity in study participants who have ulcerative colitis. This measure also assesses disease severity, based on subjective items (e.g, patients's report of abdominal pain, stooling pattern, general well-being).
• Questions to Assess Disease Knowledge [ Time Frame: Over the course of 6 months (on average we expect participants in the intervention group to complete a learning module every one to two weeks) ]
  Experimental group participants will answer 3-6 questions before and after the completion of each learning module in addition to 37 embedded assessment questions. The control group will complete a subset of these questions on two occasions.
• Questions to Assess Physical & Social Activity Participation [ Time Frame: Baseline, 3 months and 6 months ]
  Questions from the 2008/2009 National Longitudinal Survey of Children and Youth were modified for use in the current study. This includes questions on participation in school-based activities (sports, clubs, art), as well as participation in activities outside of school. Other questions ask teenagers to report the frequency of computer use, watching television, and playing video games.
• Questions to Assess Transition Readiness [ Time Frame: Baseline and 6 months ]
  The Transition Readiness Assessment Questionnaire 5.0 will be administered to determine how ready teenagers are for adult care. Though variance is expected as a function of age, greater gains in transition readiness are expected for intervention group participants.

Original Secondary Outcome: Same as current

Information By: IWK Health Centre

Dates:
Date Received: August 25, 2015
Date Started: April 2016
Date Completion: April 2017
Last Updated: September 1, 2016
Last Verified: September 2016