NCT03630146

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

August 9, 2018

Last Update Submit

April 11, 2023

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • TRANSITION-Q (measuring change)

    14-item scale that measures self-management skills in health and healthcare in adolescents with chronic health conditions.

    Baseline; up to 12 weeks after baseline; 6 months post program

Secondary Outcomes (13)

  • Disease Activity Survey (measuring change)

    Baseline; up to 12 weeks after baseline; 6 months post program

  • IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change)

    Baseline; up to 12 weeks after baseline; 6 months post program

  • Brief Resiliency Scale (measuring change)

    Baseline; up to 12 weeks after baseline; 6 months post program

  • Revised Child Anxiety and Depression Scale (measuring change)

    Baseline; up to 12 weeks after baseline; 6 months post program

  • PROMIS Pediatric Item Bank v.1.0 - Peer Relationships - Short Form 8a

    Baseline; up to 12 weeks after baseline; 6 months post program

  • +8 more secondary outcomes

Study Arms (2)

iPeer2Peer Mentorship

EXPERIMENTAL

10 sessions of 20-30 minute Skype video calls conducted over 5-12 weeks.

Behavioral: iPeer2Peer program

Waitlist Control Group

ACTIVE COMPARATOR

The control group will receive standard care but without the iPeer2Peer program.

Other: Waitlist control

Interventions

iPeer2Peer programBEHAVIORAL

In addition to standard care, youth in the experimental group will receive the iPeer2Peer Program. The iPeer2Peer program is a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with IBD aged 18-25 years) who have learned to function successfully with their disease. Mentors will encourage youth to develop and engage in disease self-management skills and provide social support.

iPeer2Peer Mentorship
Waitlist controlOTHER

The control group will receive standard care but without the iPeer2Peer Program.

Waitlist Control Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

The IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Sara Ahola Kohut, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

May 17, 2018

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)