Mission is Remission®: How Can a Disease Self-management Website Change Care?
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|ClinicalTrials.gov Identifier: NCT02694042|
Recruitment Status : Terminated (Recruitment challenges and lack of intervention engagement by participants.)
First Posted : February 29, 2016
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Crohn's Disease Pediatric Ulcerative Colitis||Behavioral: Mission is Remission®||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mission is Remission®: How Can a Disease Self-management Website Change Care?|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Mission is Remission® Group
Participants in this group will be given access to the Mission is Remission® web-based teaching and support site. They will also be emailed a link to complete online questionnaires at set time points throughout the study.
Behavioral: Mission is Remission®
A web-based teaching a support program for adolescents living with inflammatory bowel disease (IBD).
No Intervention: Control Group
Participants in this group will continue to receive standard care without access to the Mission is Remission® website. They will also be emailed a link to complete online questionnaires. At the end of the 6 month study period, participants in this group will be given access to the study website.
- 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).
- 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.
- Economic Outcome Assessment - Questions to Assess How Having a Child with IBD Affects a Parent's Life [ Time Frame: Baseline and 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694042
|Principal Investigator:||Anthony R Otley, MD MSc||IWK Health Centre|