Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 272
- 试验地点
- 2
- 主要终点
- Self-management behaviors
研究概览
简要总结
The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms.
详细描述
The purpose of this study is to test the effectiveness of and identify barriers and facilitators to the implementation of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD). Specifically, the investigators propose to determine the effect of the intervention on the primary outcome of self-management behaviors and the secondary outcomes of quality of life, transition readiness, healthcare utilization, and pain interference. In addition, the investigators will explore how patient activation moderates development of self-management behaviors and systemic, structural, and social variables that moderate relationships between patient activation, the primary outcome, and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •documentation in the electronic health record of any type of SCD
- •owns mobile device compatible with the intervention
- •access to the internet
排除标准
- •Plans to relocate outside of study site area in the next 12 months
- •Plans to transition to adult care in 12 months or less
- •Parent/caregiver or provider report of neurocognitive impairment that precludes ability to use intervention and participate in study
- •non-English speaking
结局指标
主要结局
Self-management behaviors
时间窗: baseline and 1, 3, 6, 9, 12 months
Adolescent and young adult self-report using the Transition Readiness Assessment Questionnaire 5th version (TRAQ-5; 20 items). The instrument consists of 5 scales. Individual item scores range from 1 - 5. Scale scores are determined by calculating the average of the item scores within each scale. Higher scores indicate greater transition readiness and self-management behaviors.
次要结局
- Transition readiness(baseline and 1, 3, 6, 9, and 12 months)
- Number of hospitalizations(baseline and 1, 3, 6, 9, and 12 months)
- Engagement in intervention/control (categorical)(baseline and 1, 3, 6, 9, 12 months)
- Number of ED visits(baseline and 1, 3, 6, 9, and 12 months)
- Number of attended SCD clinic visits(baseline and 1, 3, 6, 9, and 12 months)
- Pain interference(baseline and 1, 3, 6, 9, and 12, months)
- Engagement in intervention/control (continuous)(Ongoing)
- Health-related quality of life(baseline and 1, 3, 6, 9, and 12 months)
研究者
Shannon Phillips
Associate Professor-Faculty
Medical University of South Carolina