Pediatric Crohn's Disease Clinical Trial
Official title:
Mission is Remission®: How Can a Disease Self-management Website Change Care?
NCT number | NCT02694042 |
Other study ID # | MIR-1018164 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | December 2017 |
Verified date | February 2019 |
Source | IWK Health Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 39 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
Inclusion Criteria: 1. Pediatric IBD patients (approximately 100 patients randomly assigned to the Mission is Remission® group or the wait-list control group) and one of their parents/primary caregivers; 2. Patient is between 12-18 years of age, inclusive; 3. Meets screening criteria for low self-efficacy; 4. Signed informed consent from parent and assent from patient. Exclusion Criteria: 1. Not English speaking; 2. Children with cognitive impairment. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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IWK Health Centre | Alberta Children's Hospital, Stollery Children's Hospital, The Hospital for Sick Children |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Economic Outcome Assessment - Questions to Assess How Having a Child with IBD Affects a Parent's Life | Basic questions on the degree to which having a child with IBD affects a parent's life (e.g., work productivity, ability to do regular activities) will be given to parents. This questionnaire contains 5 items, which have been modified from The Work Productivity and Activity Impairment Questionnaire. Other questions have been modified from Coyte and Guerriere (1998)'s Ambulatory Home Care Record, which ask parents about the time taken away from work/home to attend appointments and receive treatment for their child's IBD. | Baseline and 6 months | |
Primary | Questionnaire to Assess Self-Efficacy - Changes from baseline | 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). | Baseline, 3 months and 6 months | |
Primary | Questionnaire to Assess Health Related Quality of Life - Changes from baseline | 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). | Baseline, 3 months and 6 months | |
Secondary | Medication Taking Behavior Questionnaire | Adolescents will complete a"Medication Taking Behavior" questionnaire to look at medication adherence in this patient population. | Baseline, 3 months and 6 months | |
Secondary | Questionnaire to Assess Disease Activity | 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). | Baseline, 3 months and 6 months | |
Secondary | Questions to Assess Disease Knowledge | 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. | 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) | |
Secondary | Questions to Assess Physical & Social Activity Participation | 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. | Baseline, 3 months and 6 months | |
Secondary | Questions to Assess Transition Readiness | 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. | Baseline and 6 months |
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