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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
Sponsor:
Collaborators:
The Hospital for Sick Children
Stollery Children's Hospital
Alberta Children's Hospital
Information provided by (Responsible Party):
IWK Health Centre

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.

Condition or disease Intervention/treatment Phase
Pediatric Crohn's Disease Pediatric Ulcerative Colitis Behavioral: Mission is Remission® Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
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


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
IWK Health Centre
The Hospital for Sick Children
Stollery Children's Hospital
Alberta Children's Hospital
Investigators
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Principal Investigator: Anthony R Otley, MD MSc IWK Health Centre

Publications:
Tanner, J., Fetus into Man: Physical growth from conception to maturity, revised edition. 1990, Cambridge, MA: Harvard University Press. 288.
Levitt, M.J., N. Guacci-Franco, and J.L. Levitt, Convoys of social support in childhood and early adolescence: Structure and function. Developmental Psychology, 1993. 29(5): p. 811-818.
Haynes, R.B., Introduction, in Compliance in Health Care, R. Haynes, D. Taylor, and D. Sackett, Editors. 1979, Johns Hopkins University Press: Baltimore. p. 1-7.
Otley, A.R., P. McGrath, and B. Christensen, The Mission Is Remission(C): a web-enabled self-management program for pediatric IBD targeting health-related quality of life: 158. Journal of Pediatric Gastroenterology and Nutrition, 2005. 41(4): p. 542.
Otley, A.R., et al., IMPACT-III is a valid, reliable and responsive measure of health-related quality of life in pediatric Crohn's disease. Journal of Pediatric Gastroenterology and Nutrition, 2006. 43(Suppl 2): p. S49
Statistics Canada. Canadian Internet Use Survey. 2010 [cited 2013 October 28th ]; Available from: http://www.statcan.gc.ca/daily-quotidien/130419/dq130419d-eng.htm.
Bronfenbrenner, U., The Ecology of Human Development: Experiments by Nature and Design. 1979, Cambridge, MA: Harvard University Press.

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Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT02694042     History of Changes
Other Study ID Numbers: MIR-1018164
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All collected data is self-reported. Participants will be offered the option of receiving a summary of the study results when they are available. These results are presented as group results (not individual).
Keywords provided by IWK Health Centre:
Pediatric inflammatory bowel disease
Crohn's disease
Ulcerative colitis
Web-based teaching and support
disease self-management
peer support
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes