Juvenile Idiopathic Arthritis Clinical Trial
— iPeer2PeerOfficial title:
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
Verified date | November 2023 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Children's Hospital of Eastern Ontario, IWK Health Centre, Provincial Health Services Authority |
Canada,
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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