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

NCT02694042 | Terminated

• 1 other identifier: MIR-1018164
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric Crohn's Disease; Pediatric Ulcerative Colitis

Keywords

Pediatric inflammatory bowel disease; Crohn's disease; Ulcerative colitis; Web-based teaching and support; disease self-management; peer support

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Medication Taking Behavior Questionnaire

  Baseline, 3 months and 6 months

• Questionnaire to Assess Disease Activity

  Baseline, 3 months and 6 months

• Questions to Assess Disease Knowledge

  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)

• Questions to Assess Physical & Social Activity Participation

  Baseline, 3 months and 6 months

• Questions to Assess Transition Readiness

  Baseline and 6 months

Other Outcomes (1)

• Economic Outcome Assessment - Questions to Assess How Having a Child with IBD Affects a Parent's Life

  Baseline and 6 months

Study Arms (2)

Mission is Remission® Group

EXPERIMENTAL

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®

Control Group

NO INTERVENTION

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.

Interventions

Mission is Remission® BEHAVIORAL

A web-based teaching a support program for adolescents living with inflammatory bowel disease (IBD).

Mission is Remission® Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• Patient is between 12-18 years of age, inclusive;
• Meets screening criteria for low self-efficacy;
• Signed informed consent from parent and assent from patient.

You may not qualify if:

• Not English speaking;
• Children with cognitive impairment.

Sponsors & Collaborators

• IWK Health Centre: lead
• The Hospital for Sick Children: collaborator
• Stollery Children's Hospital: collaborator
• Alberta Children's Hospital: collaborator

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MeSH Terms

Conditions

Pediatric Crohn's disease; Pediatric ulcerative colitis; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Anthony R Otley, MD MSc

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: February 29, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share