iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- TRANSITION-Q (measuring change)
研究概览
简要总结
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD 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
The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older mentor who has learned to manage their IBD 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).
The proposed trial aims to examine the impact of the iPeer2Peer program on self-management skills of youth with IBD (mentees) as well as health outcomes of peer mentors in the program. This innovative program leverages the Internet, commonly used by youth, to improve access and acceptability of self-management interventions while fostering social engagement in youth with IBD, thereby potentially improving HRQL.
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
- 否
入选标准
- •males and females 12-18 years old,
- •gastroenterologist-diagnosed IBD,
- •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 devices),
- •willing and able to complete online measures.
排除标准
- •significant cognitive impairments or
- •severe co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment (e.g., psychosis, active suicidal ideation),
- •participating in other peer support or self-management interventions
研究组 & 干预措施
iPeer2Peer Mentorship
10 sessions of 20-30 minute Skype video calls conducted over 5-12 weeks.
干预措施: iPeer2Peer program (Behavioral)
Waitlist Control Group
The control group will receive standard care but without the iPeer2Peer program.
干预措施: Waitlist control (Other)
结局指标
主要结局
TRANSITION-Q (measuring change)
时间窗: Baseline; up to 12 weeks after baseline; 6 months post program
14-item scale that measures self-management skills in health and healthcare in adolescents with chronic health conditions.
次要结局
- Brief Resiliency Scale (measuring change)(Baseline; up to 12 weeks after baseline; 6 months post program)
- Disease Activity Survey (measuring change)(Baseline; up to 12 weeks after baseline; 6 months post program)
- Mentor Behavior Scale (measuring change)(post-intervention (approximately following 12 weeks of calls))
- PROMIS Adult Profile v2.0 (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))
- IMPACT-III: A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease (measuring change)(Baseline; up to 12 weeks after baseline; 6 months post program)
- PROMIS Satisfaction with Social Roles and Activities (measuring change)(At beginning of study and at end of study (approximately 3 years later))
- Chronic Disease Self-Efficacy scale (measuring change)(At beginning of study and at end of study (approximately 3 years later))
- IBD Self-efficacy Scale for Adolescents and Young Adults (measuring change)(Baseline; up to 12 weeks after baseline; 6 months post program)
- Revised Child Anxiety and Depression Scale (measuring change)(Baseline; up to 12 weeks after baseline; 6 months post program)
- PROMIS Pediatric Item Bank v.1.0 - Peer Relationships - Short Form 8a(Baseline; up to 12 weeks after baseline; 6 months post program)
- Assessment of Quality if Life (AQoL-6D) (measuring change)(Baseline; up to 12 weeks after baseline; 6 months post program)
- Health Services Use and Out-of-Pocket Expense Diary (measuring change)(Baseline; up to 12 weeks after baseline; 6 months post program)
研究者
Sara Ahola Kohut
Psychologist
The Hospital for Sick Children