Next Generation Self Management: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in patient activation scores as measured by Patient Activation Measure
研究概览
简要总结
The purpose of this study is to examine the feasibility and acceptability of a mobile app to improve self-management skills and medication adherence in kidney transplantation, to assess the clinical benefit of mobile app in combination with tailored coaching using text messaging to enhance patient activation, self-management and medication adherence and to determine whether immunological biomarkers such as cell-free DNA and donor specific antibodies are associated with self-management and medication adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
- •have and use a smartphone
- •patients without pre-formed antibodies
排除标准
- •Patients <12 or >40
- •patient with pre-existing antibodies
- •patients with rejection at the time of enrollment
- •patients without a smartphone
- •patients with developmental delay or psychological impairment and unable to use an app
结局指标
主要结局
Change in patient activation scores as measured by Patient Activation Measure
时间窗: baseline, 3 months, 6 months
0-100 scale that segments patients into one of four activation levels
Change in self-management as measured by Partners In Health survey
时间窗: baseline, 3 months, 6 months
次要结局
- Medication adherence as measured by self-tracking(up to 6 months)
- Medication adherence as measured by blood levels(up to 6 months)
- Presence of cell-free DNA(up to 6 months)
- Presence of donor-specific antibodies(up to 6 months)
- Allograft function as measured by urine protein/creatinine ratio(up to 6 months)
- Allograft function as measured by serum creatinine(up to 6 months)