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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03116763
Other study ID # 1000054878
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2017
Est. completion date April 16, 2023

Study information

Verified date November 2023
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date April 16, 2023
Est. primary completion date April 16, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Canada Alberta Children's Hospital Calgary Alberta
Canada The IWK Health Centre Halifax Nova Scotia
Canada Children's Hospital - London Health Sciences London Ontario
Canada Children's Hospital of Eastern Ontario (CHEO) Ottawa Ontario
Canada The Hospital for Sick Children Toronto Ontario
Canada BC Children's Hospital Vancouver British Columbia

Sponsors (4)

Lead Sponsor Collaborator
The Hospital for Sick Children Children's Hospital of Eastern Ontario, IWK Health Centre, Provincial Health Services Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary PedsQL Arthritis Module (measuring change) Health-related quality of life Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary PROMIS Pain Interference (measuring change) Pain Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary Screen for Child Anxiety Related Disorders (measuring change) Emotional distress Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary Center for Epidemiologic Studies Depression Scale Revised (measuring change) Emotional distress Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change) Disease knowledge Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary Children's Arthritis Self-Efficacy (measuring change) Self-efficacy Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary PROMIS Pediatric Peer Relationship Scale (measuring change) Perceived social support Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary AQoL-6D, interview (measuring change) Cost utility analysis Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary Health service use and costs (measuring change) Cost utility analysis Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary Mentor Behavior Scale (measuring change) Mentor quality Post-Intervention (approximately following 12 weeks of calls)
Secondary PROMIS Adult Profile (measuring change) For mentors only: mentor physical and emotional symptoms At beginning of study and at end of study (approximately 3 years later)
Secondary PROMIS Satisfaction with Social Roles and Activities (measuring change) For mentors only: perceived social role satisfaction At beginning of study and at end of study (approximately 3 years later)
Secondary Chronic Disease Self-Efficacy Scale (measuring change) For mentors only: self-efficacy At beginning of study and at end of study (approximately 3 years later)
Secondary Mentor interaction form Record of interactions with mentees Following completion of each mentee's calls (approximately following 12 weeks of calls)
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