The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis (iPeer2Peer)
2022年10月24日 更新者：Jennifer Stinson、The Hospital for Sick Children
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
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).
研究概览
详细说明
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).
研究类型
介入性
注册 (预期的)
262
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Stephanie Luca, HBSc, MA
- 电话号码：309133 416-813-7654
- 邮箱：stephanie.luca@sickkids.ca
学习地点
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Alberta
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Calgary、Alberta、加拿大、T3B 6A8
- 尚未招聘
- Alberta Children's Hospital
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接触：
- Nadia Luca, MD
- 邮箱：Nadia.Luca@albertahealthservices.ca
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British Columbia
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Vancouver、British Columbia、加拿大
- 招聘中
- BC Children's Hospital
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接触：
- Lori Tucker, MD
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Nova Scotia
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Halifax、Nova Scotia、加拿大
- 招聘中
- The IWK Health Centre
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接触：
- Adam Huber, MSc, MD
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Ontario
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London、Ontario、加拿大、N6A 5W9
- 尚未招聘
- Children's Hospital - London Health Sciences
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接触：
- Roberta Berard, MD
- 邮箱：Roberta.Berard@lhsc.on.ca
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Ottawa、Ontario、加拿大
- 招聘中
- Children's Hospital of Eastern Ontario (CHEO)
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接触：
- Ciaran Duffy, MSc, FRCPC
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接触：
- Karen Watanabe Duffy, MD, FRCPC
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副研究员：
- Paula Forgeron, MD
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副研究员：
- Karen Watanabe Duffy, MD, FRCPC
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Toronto、Ontario、加拿大
- 招聘中
- The Hospital for Sick Children
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接触：
- Jennifer Stinson, CPNP, PhD
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副研究员：
- Sara Ahola Kohut, PhD, CPsych
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副研究员：
- Brian Feldman, MD, FRCPC
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副研究员：
- Lynn Spiegel, MD, FRCPC
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副研究员：
- Myla Moretti, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：iPeer2Peer Mentorship
In addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease).
Mentors will encourage participants to develop and engage in self-management skills and provide social support.
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10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
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有源比较器：Control Group
The control group will receive standard care but without the iPeer2Peer program.
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The control group will receive standard care but without the iPeer2Peer program.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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TRANSITION-Q (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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PedsQL Arthritis Module (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Health-related quality of life
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
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PROMIS Pain Interference (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Pain
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
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Screen for Child Anxiety Related Disorders (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Emotional distress
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
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Center for Epidemiologic Studies Depression Scale Revised (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Emotional distress
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
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Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Disease knowledge
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
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Children's Arthritis Self-Efficacy (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Self-efficacy
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Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
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PROMIS Pediatric Peer Relationship Scale (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Perceived social support
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
|
AQoL-6D, interview (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Cost utility analysis
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
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Health service use and costs (measuring change)
大体时间：Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
|
Cost utility analysis
|
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
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Mentor Behavior Scale (measuring change)
大体时间：Post-Intervention (approximately following 12 weeks of calls)
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Mentor quality
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Post-Intervention (approximately following 12 weeks of calls)
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PROMIS Adult Profile (measuring change)
大体时间：At beginning of study and at end of study (approximately 3 years later)
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For mentors only: mentor physical and emotional symptoms
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At beginning of study and at end of study (approximately 3 years later)
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PROMIS Satisfaction with Social Roles and Activities (measuring change)
大体时间：At beginning of study and at end of study (approximately 3 years later)
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For mentors only: perceived social role satisfaction
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At beginning of study and at end of study (approximately 3 years later)
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Chronic Disease Self-Efficacy Scale (measuring change)
大体时间：At beginning of study and at end of study (approximately 3 years later)
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For mentors only: self-efficacy
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At beginning of study and at end of study (approximately 3 years later)
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Mentor interaction form
大体时间：Following completion of each mentee's calls (approximately following 12 weeks of calls)
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Record of interactions with mentees
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Following completion of each mentee's calls (approximately following 12 weeks of calls)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jennifer N Stinson, CPNP, PhD、The Hospital for Sick Children
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月28日
初级完成 (预期的)
2023年5月31日
研究完成 (预期的)
2023年9月30日
研究注册日期
首次提交
2017年3月31日
首先提交符合 QC 标准的
2017年4月11日
首次发布 (实际的)
2017年4月17日
研究记录更新
最后更新发布 (实际的)
2022年10月25日
上次提交的符合 QC 标准的更新
2022年10月24日
最后验证
2022年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
iPeer2Peer Mentorship的临床试验
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The Hospital for Sick ChildrenUniversity of Alberta/Stollery Children's Hospital; The Centre Hospitalier Universitaire Sainte-Justine招聘中
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The Hospital for Sick ChildrenChildren's Hospital of Eastern Ontario; Royal University Hospital Foundation; Connecticut Children...主动，不招人
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The Hospital for Sick ChildrenEnduring Hearts; University of Alberta/Stollery Children's Hospital完全的