TRACER - Transition to Adult Care Through Coaching and Empowerment in Rheumatology: A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- PROMIS (Patient-Reported Outcomes Measurement Information System)
研究概览
简要总结
The period leading up to and following transfer from pediatric to adult care for youth with rheumatic disease is a vulnerable time leaving youth at risk of poor self-efficacy (confidence in ability to manage all aspects of their health). Adult rheumatologists face barriers in providing the complex medical, developmental and socially supportive care required for this population. Youth have expressed preference for individualized coaching during this period which involves education and support around skills and confidence-building related to their disease. The investigators have completed a feasibility trial of a Transition Coach Intervention (TCI) to help youth with rheumatic diseases gain self-efficacy and better navigate transition to adult care. The investigators will now conduct a randomized-control trial (RCT) at six centres to demonstrate TCI efficacy.
详细描述
Our primary aim is to determine the impact of a TCI on improving self-efficacy in managing medications and treatments in youth with chronic rheumatic diseases, compared to an attention control group. Our secondary aim is to explore whether a TCI improves other domains of the PROMIS Self-Efficacy for Managing Chronic Disease questionnaire (Daily Activities, Emotions, Medications, Social Interactions, and Symptoms), transition readiness and attendance at healthcare appointments in youth with chronic rheumatic diseases, compared to an attention control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •will be transferred to adult rheumatology care in the next 12 months
排除标准
- •do not expect to live independently
研究组 & 干预措施
Transition coaching
8 monthly sessions with a transition coach
干预措施: transition coaching (Behavioral)
Attention-control
Participants receive transition toolkit and 8-monthly phone calls with the research coordinator as a reminder of their participation in the study.
结局指标
主要结局
PROMIS (Patient-Reported Outcomes Measurement Information System)
时间窗: baseline, 8 and 11 months
Self-efficacy for managing chronic conditions - Self-efficacy is a "positively framed" domain. This means a higher T-score represents greater confidence in managing your condition.
次要结局
未报告次要终点
研究者
Michelle Batthish
Associate Professor
McMaster University