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iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iPeer2Peer program
Waitlist control
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BC Children's Hospital
  • The IWK Health Centre
  • Children's Hospital of Eastern Ontario
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iPeer2Peer Mentorship

Waitlist Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

TRANSITION-Q (measuring change)
14-item scale that measures self-management skills in health and healthcare in adolescents with chronic health conditions.

Secondary Outcome Measures

Disease Activity Survey (measuring change)
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.
IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change)
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.
Brief Resiliency Scale (measuring change)
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.
Revised Child Anxiety and Depression Scale (measuring change)
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
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.
IMPACT-III: A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease (measuring change)
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.
Assessment of Quality if Life (AQoL-6D) (measuring change)
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)
53-item self-report measure to assess health service use and out of pocket expenses
Mentor Behavior Scale (measuring change)
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)
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.
PROMIS Satisfaction with Social Roles and Activities (measuring change)
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)
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.
Mentor Interaction form
Record of interactions with mentees

Full Information

First Posted
August 9, 2018
Last Updated
April 11, 2023
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT03630146
Brief Title
iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
Official Title
iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iPeer2Peer Mentorship
Arm Type
Experimental
Arm Description
10 sessions of 20-30 minute Skype video calls conducted over 5-12 weeks.
Arm Title
Waitlist Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive standard care but without the iPeer2Peer program.
Intervention Type
Behavioral
Intervention Name(s)
iPeer2Peer program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist control
Intervention Description
The control group will receive standard care but without the iPeer2Peer Program.
Primary Outcome Measure Information:
Title
TRANSITION-Q (measuring change)
Description
14-item scale that measures self-management skills in health and healthcare in adolescents with chronic health conditions.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Secondary Outcome Measure Information:
Title
Disease Activity Survey (measuring change)
Description
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.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change)
Description
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.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
Brief Resiliency Scale (measuring change)
Description
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.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
Revised Child Anxiety and Depression Scale (measuring change)
Description
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.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
PROMIS Pediatric Item Bank v.1.0 - Peer Relationships - Short Form 8a
Description
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.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
IMPACT-III: A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease (measuring change)
Description
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.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
Assessment of Quality if Life (AQoL-6D) (measuring change)
Description
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.
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
Health Services Use and Out-of-Pocket Expense Diary (measuring change)
Description
53-item self-report measure to assess health service use and out of pocket expenses
Time Frame
Baseline; up to 12 weeks after baseline; 6 months post program
Title
Mentor Behavior Scale (measuring change)
Description
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.
Time Frame
post-intervention (approximately following 12 weeks of calls)
Title
PROMIS Adult Profile v2.0 (measuring change)
Description
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.
Time Frame
At beginning of study and at end of study (approximately 3 years later)
Title
PROMIS Satisfaction with Social Roles and Activities (measuring change)
Description
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.
Time Frame
At beginning of study and at end of study (approximately 3 years later)
Title
Chronic Disease Self-Efficacy scale (measuring change)
Description
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.
Time Frame
At beginning of study and at end of study (approximately 3 years later)
Title
Mentor Interaction form
Description
Record of interactions with mentees
Time Frame
Following completion of each mentee's calls (approximately following 12 weeks of calls)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Ahola Kohut, PhD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
The IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease

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