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临床试验/NCT01986400
NCT01986400已完成不适用

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

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Feasibility

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

研究组 & 干预措施

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).

干预措施: 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).

结局指标

主要结局

Feasibility

时间窗: 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)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Stinson

Principal Investigator

The Hospital for Sick Children

研究点 (2)

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