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Clinical Trials/NCT01986400
NCT01986400CompletedNot Applicable

Virtual Peer-to-Peer Support Mentoring for Adolescents With Juvenile Idiopathic Arthritis: A Feasibility Pilot Randomized Controlled Trial

The Hospital for Sick Children2 sites in 1 country30 target enrollmentStarted: July 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Feasibility

Study Overview

Brief Summary

Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes and quality of life in adolescents with Juvenile Idiopathic Arthritis

Detailed Description

The aim of this project is to develop and examine the impact of a virtual peer support program on health outcomes and quality of life of adolescents with Juvenile Idiopathic Arthritis using a waitlist randomized controlled trial. In addition to standard medical care, adolescents in the experimental group will receive a manualized peer mentorship program that will provide modeling and reinforcement by trained young adults aged 16-25 years who have learned to function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45 minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support, and self-management skills.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • males and females 12-18 years old
  • diagnosed with Juvenile Idiopathic Arthritis (JIA) by a Rheumatologist (any sub-type)
  • able to speak and read English
  • access to Internet connection, computer capable of using free Skype software
  • willing and able to complete online measures

Exclusion Criteria

  • significant cognitive impairments
  • major co-morbid illnesses (i.e., psychiatric conditions) likely to influence HRQL assessment
  • participating in peer support or self-management interventions (e.g., Teens Taking Charge).

Arms & Interventions

Virtual Peer-to-Peer Support Mentoring

Experimental

In addition to standard medical care, adolescents in the experimental group will receive the VP2P support program, a manualized peer-mentorship program that will provide modeling and reinforcement by peers (young adults with JIA aged 16-25 years who have learned to function successfully with their JIA to the mentored participants).

Intervention: Virtual Peer-to-Peer Support Mentoring (Behavioral)

Wait-list Control

No Intervention

The control group will receive usual care but without the mentorship intervention. They will be offered the VP2P support program after completion of outcome measures (T1 - to be completed online prior to randomization; T2 - at program completion).

Outcomes

Primary Outcomes

Feasibility

Time Frame: 2 months

1. Accrual and Dropout Rates - recruitment and withdrawal rates will be calculated that the end of the study. 2. Compliance (Level of Engagement) - rates of completion of weekly calls and online outcome measures will be calculated that the end of the study - defined as 100% when the participant completes 10 calls over 8 weeks with all online measures completed. 3. Adolescents' Perception of JIA VP2P Program - the acceptability of and satisfaction with the JIA VP2P support program as measured through semi-structured phone interviews with mentees and focus groups with mentors 4. Estimates of Intervention Effects (e.g., effect sizes, variance measures/standard deviation) on health outcomes to inform the calculation of an appropriate sample size for the future definitive multi-centred randomized controlled trial (RCT)

Secondary Outcomes

  • Health-Related Quality of Life (HRQL)(Baseline, 2 months)
  • Self-Efficacy(Baseline, 2 Months)
  • Pain(Baseline, 2 months)
  • Adherence(Baseline, 2 Months)
  • Knowledge and Social Support(Baseline, 2 Months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Stinson

Principal Investigator

The Hospital for Sick Children

Study Sites (2)

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