Clinical trial NCT03116763: The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis
Official title: The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
name: IWK Health Centre
name: Children's Hospital of Eastern Ontario
First posted: 2017-04-17
Enrollment: 164
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility 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.

Primary outcomes:
measure: TRANSITION-Q (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Secondary outcomes:
measure: PedsQL Arthritis Module (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: PROMIS Pain Interference (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: Screen for Child Anxiety Related Disorders (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: Center for Epidemiologic Studies Depression Scale Revised (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: Children's Arthritis Self-Efficacy (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: PROMIS Pediatric Peer Relationship Scale (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: AQoL-6D, interview (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: Health service use and costs (measuring change)
timeFrame: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
measure: Mentor Behavior Scale (measuring change)
timeFrame: Post-Intervention (approximately following 12 weeks of calls)
measure: PROMIS Adult Profile (measuring change)
timeFrame: At beginning of study and at end of study (approximately 3 years later)
measure: PROMIS Satisfaction with Social Roles and Activities (measuring change)
timeFrame: At beginning of study and at end of study (approximately 3 years later)
measure: Chronic Disease Self-Efficacy Scale (measuring change)
timeFrame: At beginning of study and at end of study (approximately 3 years later)
measure: Mentor interaction form
timeFrame: Following completion of each mentee's calls (approximately following 12 weeks of calls)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: The IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: Children's Hospital - London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario (CHEO)
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer N Stinson, CPNP, PhD
role: PRINCIPAL_INVESTIGATOR
References: