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临床试验/NCT03116763
NCT03116763已完成不适用

The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial

The Hospital for Sick Children8 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2017年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
8
主要终点
TRANSITION-Q (measuring change)

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

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
  • 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.

排除标准

  • 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.

结局指标

主要结局

TRANSITION-Q (measuring change)

时间窗: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)

次要结局

  • Screen for Child Anxiety Related Disorders (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • PedsQL Arthritis Module (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • PROMIS Pain Interference (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • Center for Epidemiologic Studies Depression Scale Revised (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • Children's Arthritis Self-Efficacy (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • AQoL-6D, interview (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • Health service use and costs (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • Chronic Disease Self-Efficacy Scale (measuring change)(At beginning of study and at end of study (approximately 3 years later))
  • PROMIS Pediatric Peer Relationship Scale (measuring change)(Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post)
  • Mentor Behavior Scale (measuring change)(Post-Intervention (approximately following 12 weeks of calls))
  • PROMIS Adult Profile (measuring change)(At beginning of study and at end of study (approximately 3 years later))
  • PROMIS Satisfaction with Social Roles and Activities (measuring change)(At beginning of study and at end of study (approximately 3 years later))
  • Mentor interaction form(Following completion of each mentee's calls (approximately following 12 weeks of calls))

研究者

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

Jennifer Stinson

Senior Scientist

The Hospital for Sick Children

研究点 (8)

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