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Trial record 6 of 33 for:    Recruiting, Not yet recruiting, Available Studies | "Arthritis, Juvenile Rheumatoid"

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

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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

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).

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Behavioral: iPeer2Peer Mentorship Other: Active Comparator: Control Group Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: iPeer2Peer Mentorship
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.
Other: Active Comparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. PedsQL Arthritis Module (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Health-related quality of life

  2. PROMIS Pain Interference (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Pain

  3. Screen for Child Anxiety Related Disorders (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Emotional distress

  4. 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

  5. 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

  6. Children's Arthritis Self-Efficacy (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Self-efficacy

  7. PROMIS Pediatric Peer Relationship Scale (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Perceived social support

  8. AQoL-6D, interview (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Cost utility analysis

  9. Health service use and costs (measuring change) [ Time Frame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post ]
    Cost utility analysis

  10. Mentor Behavior Scale (measuring change) [ Time Frame: Post-Intervention (approximately following 12 weeks of calls) ]
    Mentor quality

  11. 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

  12. 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

  13. 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

  14. Mentor interaction form [ Time Frame: Following completion of each mentee's calls (approximately following 12 weeks of calls) ]
    Record of interactions with mentees



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116763


Contacts
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

Locations
Canada, Alberta
Alberta Children's Hospital Not yet recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Nadia Luca, MD       Nadia.Luca@albertahealthservices.ca   
Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Lori Tucker, MD         
Canada, Nova Scotia
The IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada
Contact: Adam Huber, MSc, MD         
Canada, Ontario
Children's Hospital - London Health Sciences Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Roberta Berard, MD       Roberta.Berard@lhsc.on.ca   
Children's Hospital of Eastern Ontario (CHEO) Recruiting
Ottawa, Ontario, Canada
Contact: Ciaran Duffy, MSc, FRCPC         
Contact: Karen Watanabe Duffy, MD, FRCPC         
Sub-Investigator: Paula Forgeron, MD         
Sub-Investigator: Karen Watanabe Duffy, MD, FRCPC         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
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         
Sponsors and Collaborators
The Hospital for Sick Children
Provincial Health Services Authority
IWK Health Centre
Children's Hospital of Eastern Ontario
Investigators
Principal Investigator: Jennifer N Stinson, CPNP, PhD The Hospital for Sick Children

Responsible Party: Jennifer Stinson, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03116763     History of Changes
Other Study ID Numbers: 1000054878
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases