ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03116763
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Provincial Health Services Authority
IWK Health Centre
Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

March 31, 2017
April 17, 2017
July 19, 2018
March 28, 2017
May 31, 2019   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT03116763 on ClinicalTrials.gov Archive Site
  • PedsQL Arthritis Module (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Health-related quality of life
  • PROMIS Pain Interference (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Pain
  • Screen for Child Anxiety Related Disorders (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Emotional distress
  • 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
  • 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
  • Children's Arthritis Self-Efficacy (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Self-efficacy
  • PROMIS Pediatric Peer Relationship Scale (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Perceived social support
  • AQoL-6D, interview (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Cost utility analysis
  • Health service use and costs (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Cost utility analysis
  • Mentor Behavior Scale (measuring change) [ Time Frame: Post-Intervention (approximately following 12 weeks of calls) ]
    Mentor quality
  • 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
  • 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
  • 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
  • Mentor interaction form [ Time Frame: Following completion of each mentee's calls (approximately following 12 weeks of calls) ]
    Record of interactions with mentees
Same as current
Not Provided
Not Provided
 
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis
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).
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).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Juvenile Idiopathic Arthritis
  • Behavioral: iPeer2Peer Mentorship
    10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
  • Other: Active Comparator: Control Group
    The control group will receive standard care but without the iPeer2Peer program.
  • 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.
    Intervention: Behavioral: iPeer2Peer Mentorship
  • Active Comparator: Control Group
    The control group will receive standard care but without the iPeer2Peer program.
    Intervention: Other: Active Comparator: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
262
Same as current
September 30, 2019
May 31, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 18 Years   (Child, Adult)
No
Contact: Jennifer N Stinson, CPNP, PhD 416-813-7654 ext 304514 jennifer.stinson@sickkids.ca
Contact: Stephanie Luca, HBSc, MA 416-813-7654 ext 309133 stephanie.luca@sickkids.ca
Canada
 
 
NCT03116763
1000054878
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Jennifer Stinson, The Hospital for Sick Children
The Hospital for Sick Children
  • Provincial Health Services Authority
  • IWK Health Centre
  • Children's Hospital of Eastern Ontario
Principal Investigator: Jennifer N Stinson, CPNP, PhD The Hospital for Sick Children
The Hospital for Sick Children
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP