iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Other: Waitlist controlBehavioral: iPeer2Peer program
- Registration Number
- NCT03630146
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer program and those in the control group (no mentor).
- Detailed Description
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer program and those in the control group (no mentor).
The proposed trial aims to examine the impact of the iPeer2Peer program on self-management skills of youth with IBD (mentees) as well as health outcomes of peer mentors in the program. This innovative program leverages the Internet, commonly used by youth, to improve access and acceptability of self-management interventions while fostering social engagement in youth with IBD, thereby potentially improving HRQL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- males and females 12-18 years old,
- gastroenterologist-diagnosed IBD,
- able to speak and read English,
- access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet devices),
- willing and able to complete online measures.
- significant cognitive impairments or
- severe co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment (e.g., psychosis, active suicidal ideation),
- participating in other peer support or self-management interventions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waitlist Control Group Waitlist control The control group will receive standard care but without the iPeer2Peer program. iPeer2Peer Mentorship iPeer2Peer program 10 sessions of 20-30 minute Skype video calls conducted over 5-12 weeks.
- Primary Outcome Measures
Name Time Method TRANSITION-Q (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 14-item scale that measures self-management skills in health and healthcare in adolescents with chronic health conditions.
- Secondary Outcome Measures
Name Time Method Disease Activity Survey (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 21-item survey to measure disease activity and alternative resources therapies used by patients. The scale used in this study is from the Brief Pain Inventory. The scale ranges from 0 to 10 and the higher the value the worse the outcome.
Brief Resiliency Scale (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 6-item measure that assesses an individual's ability to bounce back or recover from stress. The total range is a score from 6 to 30. A higher final score represents a better outcome.
Mentor Behavior Scale (measuring change) post-intervention (approximately following 12 weeks of calls) 15-item measure of 4 factors that affect mentor quality: structure, engagement, autonomy support, and competency support. The scale ranges in values from 1 to 5. The higher the score the higher the mentor is rated.
PROMIS Adult Profile v2.0 (measuring change) At beginning of study and at end of study (approximately 3 years later) For mentors only. 29-item collection of short forms from 7 health domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. The scale is scored from 1 to 5. The higher the score the worse the outcome.
Mentor Interaction form Following completion of each mentee's calls (approximately following 12 weeks of calls) Record of interactions with mentees
IMPACT-III: A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 35-item quality of life measure specific to pediatric IBD populations. Domain scores include: bowel symptoms, systemic symptoms, emotional functioning, social functioning, body image, and treatment/interventions.
PROMIS Satisfaction with Social Roles and Activities (measuring change) At beginning of study and at end of study (approximately 3 years later) For mentors only. 44-item questionnaire that measures satisfaction with one's social functioning (e.g., ability to participate in social roles and activities, and satisfaction with social roles and responsibilities) and social relationships (e.g., companionship, emotional, informational and instrumental support, and social isolation) The scale ranges from scores 1 to 5. The higher the score the better the outcome.
Chronic Disease Self-Efficacy scale (measuring change) At beginning of study and at end of study (approximately 3 years later) For mentors only. 33-item measure with 10 subscales. The scale ranges from scores of 1 to 10. The higher the score the better the outcome.
subscales are conceptually divided into 3 types of self-efficacy: 1). ability to self-management behaviors, 2) ability to manage disease in general, and 3) ability to achieve outcomes.IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 13-item disease-specific scale to assess SE toward disease management for adolescents and young adults with IBD. Scale scores range from 1 to 5. The higher value represents a better outcome.
Revised Child Anxiety and Depression Scale (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 25-item self-report measure of anxiety and depression characteristics. Measure includes a score for total anxiety, total depression, and total anxiety and depression. The scale ranges from a minimum score of 0 to a maximum score of 3. A higher score represents a worse outcome.
PROMIS Pediatric Item Bank v.1.0 - Peer Relationships - Short Form 8a Baseline; up to 12 weeks after baseline; 6 months post program 15-item measure of social health via social function and overall sociability. The scale ranges from value of 0 to 4. The higher the value the better the outcome.
Assessment of Quality if Life (AQoL-6D) (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 20-item self-report measure for six separately scored dimensions and a simple global "utility" score. The scores range from 1 to 5. The higher the score the worse the outcome.
Health Services Use and Out-of-Pocket Expense Diary (measuring change) Baseline; up to 12 weeks after baseline; 6 months post program 53-item self-report measure to assess health service use and out of pocket expenses
Trial Locations
- Locations (4)
BC Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
The IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
BC Children's Hospital🇨🇦Vancouver, British Columbia, Canada