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The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis (iPeer2Peer)

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iPeer2Peer Mentorship
Active Comparator: Control Group
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • males and females 12-18 years old
  • rheumatologist-diagnosed JIA according to ILAR criteria
  • 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 sticks)
  • willing and able to complete online measures.

Exclusion Criteria:

  • significant cognitive impairments
  • major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment
  • participating in other peer support or self-management interventions.

Sites / Locations

  • Alberta Children's Hospital
  • BC Children's HospitalRecruiting
  • The IWK Health CentreRecruiting
  • Children's Hospital - London Health Sciences
  • Children's Hospital of Eastern Ontario (CHEO)Recruiting
  • The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iPeer2Peer Mentorship

Control Group

Arm Description

In addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease). Mentors will encourage participants to develop and engage in self-management skills and provide social support.

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

Outcomes

Primary Outcome Measures

TRANSITION-Q (measuring change)
14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)

Secondary Outcome Measures

PedsQL Arthritis Module (measuring change)
Health-related quality of life
PROMIS Pain Interference (measuring change)
Pain
Screen for Child Anxiety Related Disorders (measuring change)
Emotional distress
Center for Epidemiologic Studies Depression Scale Revised (measuring change)
Emotional distress
Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
Disease knowledge
Children's Arthritis Self-Efficacy (measuring change)
Self-efficacy
PROMIS Pediatric Peer Relationship Scale (measuring change)
Perceived social support
AQoL-6D, interview (measuring change)
Cost utility analysis
Health service use and costs (measuring change)
Cost utility analysis
Mentor Behavior Scale (measuring change)
Mentor quality
PROMIS Adult Profile (measuring change)
For mentors only: mentor physical and emotional symptoms
PROMIS Satisfaction with Social Roles and Activities (measuring change)
For mentors only: perceived social role satisfaction
Chronic Disease Self-Efficacy Scale (measuring change)
For mentors only: self-efficacy
Mentor interaction form
Record of interactions with mentees

Full Information

First Posted
March 31, 2017
Last Updated
October 24, 2022
Sponsor
The Hospital for Sick Children
Collaborators
Provincial Health Services Authority, IWK Health Centre, Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT03116763
Brief Title
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis
Acronym
iPeer2Peer
Official Title
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Provincial Health Services Authority, IWK Health Centre, Children's Hospital of Eastern Ontario

4. Oversight

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

5. Study Description

Brief Summary
The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis 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
Arthritis is a common childhood illness that makes everyday activities hard for young people. It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This can make it hard for children and teens to see friends and do the activities that they like. The goal of this project is to find out if the newly developed peer mentoring program called iPeer2Peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis. The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
iPeer2Peer Mentorship
Arm Type
Experimental
Arm Description
In addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease). Mentors will encourage participants to develop and engage in self-management skills and provide social support.
Arm Title
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 Mentorship
Intervention Description
10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
Intervention Type
Other
Intervention Name(s)
Active Comparator: Control Group
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 measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary Outcome Measure Information:
Title
PedsQL Arthritis Module (measuring change)
Description
Health-related quality of life
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
PROMIS Pain Interference (measuring change)
Description
Pain
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
Screen for Child Anxiety Related Disorders (measuring change)
Description
Emotional distress
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
Center for Epidemiologic Studies Depression Scale Revised (measuring change)
Description
Emotional distress
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
Description
Disease knowledge
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
Children's Arthritis Self-Efficacy (measuring change)
Description
Self-efficacy
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
PROMIS Pediatric Peer Relationship Scale (measuring change)
Description
Perceived social support
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
AQoL-6D, interview (measuring change)
Description
Cost utility analysis
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
Health service use and costs (measuring change)
Description
Cost utility analysis
Time Frame
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Title
Mentor Behavior Scale (measuring change)
Description
Mentor quality
Time Frame
Post-Intervention (approximately following 12 weeks of calls)
Title
PROMIS Adult Profile (measuring change)
Description
For mentors only: mentor physical and emotional symptoms
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: perceived social role satisfaction
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: self-efficacy
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 rheumatologist-diagnosed JIA according to ILAR criteria 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 sticks) willing and able to complete online measures. Exclusion Criteria: significant cognitive impairments major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment participating in other peer support or self-management interventions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer N Stinson, CPNP, PhD
Phone
416-813-7654
Ext
304514
Email
jennifer.stinson@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Luca, HBSc, MA
Phone
416-813-7654
Ext
309133
Email
stephanie.luca@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer N Stinson, CPNP, PhD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Luca, MD
Email
Nadia.Luca@albertahealthservices.ca
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Tucker, MD
Facility Name
The IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Huber, MSc, MD
Facility Name
Children's Hospital - London Health Sciences
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Berard, MD
Email
Roberta.Berard@lhsc.on.ca
Facility Name
Children's Hospital of Eastern Ontario (CHEO)
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ciaran Duffy, MSc, FRCPC
First Name & Middle Initial & Last Name & Degree
Karen Watanabe Duffy, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Paula Forgeron, MD
First Name & Middle Initial & Last Name & Degree
Karen Watanabe Duffy, MD, FRCPC
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Stinson, CPNP, PhD
First Name & Middle Initial & Last Name & Degree
Sara Ahola Kohut, PhD, CPsych
First Name & Middle Initial & Last Name & Degree
Brian Feldman, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Lynn Spiegel, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Myla Moretti, PhD

12. IPD Sharing Statement

Learn more about this trial

The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis

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