Implementation and Effectiveness Evaluation of the iPeer2Peer Support Mentorship Program Within Pediatric Thoracic Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Feasibility: Semi-structured Interview (Mentees)
研究概览
简要总结
With the on-going presence of a chronic illness, daily immunosuppressive medications, and the need for continuous medical supervision, pediatric transplant recipients face considerable psychosocial stresses. Treatment nonadherence is a major issue in pediatric transplantation and can lead to increased rates of hospitalization, rejection episodes, graft loss and death. An online peer support mentorship program (iPeer2Peer) is proposed as one intervention that could enhance patient care management, increase treatment adherence, reduce social isolation and improve health outcomes for this highly vulnerable population. The proposed trial will determine 1) implementation outcomes of the iPeer2Peer intervention in terms of: (a) feasibility and adoption, (b) acceptability and appropriateness and (c) level of engagement with the program, and 2) effectiveness of the iPeer2Peer intervention on improving health outcomes including disease self-management skills, treatment adherence, quality of life, perceived social support, stress and coping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart and/or lung transplant recipient,
- •at least 4 months post-transplant,
- •between the ages of 12 and 25 years,
- •able to speak and read English,
- •willingness to commit to 5-10 texts and/or calls of 20-30 minutes each over a period of 15 weeks.
排除标准
- •have a significant cognitive impairments as assessed by a qualified healthcare provider,
- •have a diagnosis of an active psychological disorder (e.g., Major Depressive Disorder, Generalized Anxiety Disorder) likely to influence assessment of health-related quality of life and/or interfere with their ability to manage their transplant regimen (a diagnosis of an active psychological disorder will be determined for mentees through medical chart review and self-reported by mentors), and
- •are participating in other peer support or self-management interventions
结局指标
主要结局
Feasibility: Semi-structured Interview (Mentees)
时间窗: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Appropriateness (Mentors)
时间窗: Study completion, an average of 1 year
Semi-structured Interview
Acceptability: Semi-structured Interview (Mentors)
时间窗: Study completion, an average of 1 year
Semi-structured Interview
Level of Engagement (Mentors)
时间窗: Study completion, an average of 1 year
Semi-structured Interview
Acceptability: Semi-structured Interview (Mentees)
时间窗: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Adoption (Mentees)
时间窗: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Adoption (Mentors)
时间窗: Study completion, an average of 1 year
Semi-structured Interview
Feasibility: Semi-structured Interview (Mentors)
时间窗: Study completion, an average of 1 year
Semi-structured Interview
Feasibility: Accrual and dropout rates
时间窗: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Accrual and dropout rates
Feasibility: Compliance with iPeer2Peer program (Mentees)
时间窗: 12 weeks post-program completion
Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)
Feasibility: Compliance with iPeer2Peer program (Mentors)
时间窗: Study completion, an average of 1 year
Compliance with iPeer2Peer program (an 80% rate of completion of five calls and online outcome measures)
Appropriateness (Mentees)
时间窗: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Level of Engagement (Mentees)
时间窗: 15 weeks after baseline/immediately after the intervention
Semi-structured Interview
Adoption
时间窗: Mentees - 12 weeks post-program completion; Mentors - study completion, an average of 1 year
Accrual and dropout rates
次要结局
- Quality of Life (Mentees)(Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion)
- Resiliency (Mentees)(Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion)
- Quality of Mentor Behaviour (Mentees)(15 weeks after baseline/immediately after the intervention)
- Change in Physical and Emotional Symptoms (Mentors)(Baseline, pre-intervention; study completion, an average of 1 year)
- Disease self-management skills (Mentees)(Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion)
- Perceived Social Support (Mentees)(Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion)
- Change in Self-efficacy (Mentors): Chronic Disease Self-Efficacy Scale(Baseline, pre-intervention; study completion, an average of 1 year)
- Emotional Distress (Mentees)(Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion)
- Change in Perceived Social Role Satisfaction (Mentors)(Baseline, pre-intervention; study completion, an average of 1 year)
- Treatment adherence (Mentees)(Baseline, 15 weeks after baseline/immediately after the intervention, 12 weeks post-program completion)
研究者
Samantha Anthony
Principal Investigator
The Hospital for Sick Children