Clinical trial NCT03630146: iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
Official title: iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: TRANSITION-Q (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
Secondary outcomes:
measure: Disease Activity Survey (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: Brief Resiliency Scale (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: Revised Child Anxiety and Depression Scale (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: PROMIS Pediatric Item Bank v.1.0 - Peer Relationships - Short Form 8a
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: IMPACT-III: A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: Assessment of Quality if Life (AQoL-6D) (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: Health Services Use and Out-of-Pocket Expense Diary (measuring change)
timeFrame: Baseline; up to 12 weeks after baseline; 6 months post program
measure: Mentor Behavior Scale (measuring change)
timeFrame: post-intervention (approximately following 12 weeks of calls)
measure: PROMIS Adult Profile v2.0 (measuring change)
timeFrame: At beginning of study and at end of study (approximately 3 years later)
measure: PROMIS Satisfaction with Social Roles and Activities (measuring change)
timeFrame: At beginning of study and at end of study (approximately 3 years later)
measure: Chronic Disease Self-Efficacy scale (measuring change)
timeFrame: At beginning of study and at end of study (approximately 3 years later)
measure: Mentor Interaction form
timeFrame: Following completion of each mentee's calls (approximately following 12 weeks of calls)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: The IWK Health Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Sara Ahola Kohut, PhD
role: PRINCIPAL_INVESTIGATOR
References: