- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03116763
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis (iPeer2Peer)
October 24, 2022 updated by: Jennifer Stinson, The Hospital for Sick Children
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
262
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephanie Luca, HBSc, MA
- Phone Number: 309133 416-813-7654
- Email: stephanie.luca@sickkids.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Not yet recruiting
- Alberta Children's Hospital
-
Contact:
- Nadia Luca, MD
- Email: Nadia.Luca@albertahealthservices.ca
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Recruiting
- BC Children's Hospital
-
Contact:
- Lori Tucker, MD
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- Recruiting
- The IWK Health Centre
-
Contact:
- Adam Huber, MSc, MD
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- Not yet recruiting
- Children's Hospital - London Health Sciences
-
Contact:
- Roberta Berard, MD
- Email: Roberta.Berard@lhsc.on.ca
-
Ottawa, Ontario, Canada
- Recruiting
- Children's Hospital of Eastern Ontario (CHEO)
-
Contact:
- Ciaran Duffy, MSc, FRCPC
-
Contact:
- Karen Watanabe Duffy, MD, FRCPC
-
Sub-Investigator:
- Paula Forgeron, MD
-
Sub-Investigator:
- Karen Watanabe Duffy, MD, FRCPC
-
Toronto, Ontario, Canada
- Recruiting
- The Hospital for Sick Children
-
Contact:
- Jennifer Stinson, CPNP, PhD
-
Sub-Investigator:
- Sara Ahola Kohut, PhD, CPsych
-
Sub-Investigator:
- Brian Feldman, MD, FRCPC
-
Sub-Investigator:
- Lynn Spiegel, MD, FRCPC
-
Sub-Investigator:
- Myla Moretti, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iPeer2Peer Mentorship
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.
|
10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
|
Active Comparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.
|
The control group will receive standard care but without the iPeer2Peer program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TRANSITION-Q (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PedsQL Arthritis Module (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Health-related quality of life
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
PROMIS Pain Interference (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Pain
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Screen for Child Anxiety Related Disorders (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Emotional distress
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Center for Epidemiologic Studies Depression Scale Revised (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Emotional distress
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Disease knowledge
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Children's Arthritis Self-Efficacy (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Self-efficacy
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
PROMIS Pediatric Peer Relationship Scale (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Perceived social support
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
AQoL-6D, interview (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Cost utility analysis
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Health service use and costs (measuring change)
Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Cost utility analysis
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Mentor Behavior Scale (measuring change)
Time Frame: Post-Intervention (approximately following 12 weeks of calls)
|
Mentor quality
|
Post-Intervention (approximately following 12 weeks of calls)
|
PROMIS Adult Profile (measuring change)
Time Frame: At beginning of study and at end of study (approximately 3 years later)
|
For mentors only: mentor physical and emotional symptoms
|
At beginning of study and at end of study (approximately 3 years later)
|
PROMIS Satisfaction with Social Roles and Activities (measuring change)
Time Frame: At beginning of study and at end of study (approximately 3 years later)
|
For mentors only: perceived social role satisfaction
|
At beginning of study and at end of study (approximately 3 years later)
|
Chronic Disease Self-Efficacy Scale (measuring change)
Time Frame: At beginning of study and at end of study (approximately 3 years later)
|
For mentors only: self-efficacy
|
At beginning of study and at end of study (approximately 3 years later)
|
Mentor interaction form
Time Frame: Following completion of each mentee's calls (approximately following 12 weeks of calls)
|
Record of interactions with mentees
|
Following completion of each mentee's calls (approximately following 12 weeks of calls)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer N Stinson, CPNP, PhD, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2017
Primary Completion (Anticipated)
May 31, 2023
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
March 31, 2017
First Submitted That Met QC Criteria
April 11, 2017
First Posted (Actual)
April 17, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 24, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000054878
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Juvenile Idiopathic Arthritis
-
University of AarhusAarhus University HospitalCompletedPolyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, OligoarthritisDenmark
-
Institut National de la Santé Et de la Recherche...CompletedSystemic-Onset Juvenile Idiopathic ArthritisFrance
-
GeneScience Pharmaceuticals Co., Ltd.Not yet recruitingActive Systemic Juvenile Idiopathic ArthritisChina
-
Novartis PharmaceuticalsCompletedSystemic Juvenile Idiopathic Arthritis (SJIA)Italy, Russian Federation, Turkey, Belgium, Spain, Germany, France, Israel, Canada, United States, Hungary, Austria, Brazil, Sweden, Netherlands, Poland
-
Novartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompletedSystemic Juvenile Idiopathic Arthritis With Active FlareUnited States, Argentina, Canada, Switzerland, Germany, Israel, South Africa, Belgium, Italy, Spain, France, Brazil, Turkey, Hungary, Poland, Norway, Sweden, Netherlands, Peru
-
University of British ColumbiaUniversity of Manitoba; The Hospital for Sick Children; McGill University Health... and other collaboratorsRecruiting
-
AbbVieCompletedPolyarticular Juvenile Idiopathic Arthritis
-
NovartisCompletedArthritis, Juvenile RheumatoidItaly
-
Assistance Publique - Hôpitaux de ParisRecruitingJuvenile Idiopathic Arthritis (JIA)France
-
AbbVieRecruitingJuvenile Idiopathic Arthritis (JIA)United States, Germany, Hungary, Israel, Puerto Rico, Spain, Japan, Canada, Italy, Sweden
Clinical Trials on iPeer2Peer Mentorship
-
The Hospital for Sick ChildrenChildren's Hospital of Eastern Ontario; Royal University Hospital Foundation; Connecticut Children's Medical CenterActive, not recruiting
-
The Hospital for Sick ChildrenEnduring Hearts; University of Alberta/Stollery Children's HospitalCompleted
-
The Hospital for Sick ChildrenBritish Columbia Children's Hospital; University of Alberta/Stollery Children... and other collaboratorsRecruiting
-
The Hospital for Sick ChildrenCompletedInflammatory Bowel DiseasesCanada
-
New York State Psychiatric InstituteCompletedAnorexia Nervosa | Binge-Eating Disorder | Bulimia Nervosa | Eating DisorderUnited States
-
Albert Einstein College of MedicineVanderbilt University Medical CenterCompleted
-
Unity Health TorontoCovenant House Toronto; The Living Rock Ministries; The Resource Association...CompletedHomeless PersonsCanada
-
Rush University Medical CenterCompleted
-
Beth Israel Deaconess Medical CenterPatient-Centered Outcomes Research Institute; Medical University of South CarolinaCompletedChronic Kidney Disease | End-Stage Renal DiseaseUnited States
-
University of ManitobaHeart and Stroke Foundation of Canada; Children's Hospital Research Institute...Not yet recruitingCardiovascular Diseases | Type2diabetesCanada