Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Chronic Pain: A Feasibility Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 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 chronic pain.
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 chronic pain 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
- 否
入选标准
- •males and females 12-18 years old
- •diagnosed chronic pain condition (e.g., neuropathic pain, Complex Regional Pain Syndrome, chronic musculoskeletal pain, chronic daily headache, chronic widespread pain)
- •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., WebMap).
研究组 & 干预措施
Virtual Peer-to-Peer Support Mentoring
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 chronic pain aged 16-25 years who have learned to function successfully with their chronic pain to the mentored participants).
干预措施: Virtual Peer-to-Peer Support Mentoring (Behavioral)
Waitlist Control
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 Chronic Pain VP2P Program - the acceptability of and satisfaction with the Chronic Pain 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
- Self-Management(Baseline, 2 months)
- Emotional Symptoms(Baseline, 2 months)
- Health-Related Quality of Life (HRQL)(Baseline, 2 months)
- Self-Efficacy(Baseline, 2 months)
- Social Support(Baseline, 2 months)
- Pain(Baseline, 2 months)
- Pain Coping(Baseline, 2 months)
- Disability(Baseline, 2 months)
研究者
Jennifer Stinson
Principal Investigator
The Hospital for Sick Children