Prediction of Medication Compliance Following Renal Transplantation
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
- Prediction of early medication adherence
研究概览
简要总结
The purpose of this study is to quantitate pre-transplant medication compliance, dialysis compliance, and related psychological variables, and then examine their validity as predictors of post-transplant noncompliant behaviors and clinically relevant outcomes (acute rejection, graft loss, or death).
Hypothesis: Noncompliance with pre-transplant medication or with the dialysis prescription, and specific psychological variables predict similarly noncompliant behaviors after transplantation.
详细描述
This pilot study is intended to provide preliminary data about the feasibility of recruiting a cohort of subjects on hemodialysis and following them prospectively through the transplant procedure. The study will document patient adherence to medications and treatment, both before and after surgery. These preliminary data will permit appropriate design and power calculations for a future study assessing our ability to predict post-transplant compliance, based on pre-transplant behaviors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult hemodialysis patients in renal transplant evaluation
- •Able to read test forms
- •Responsible for their own medications
排除标准
- •Patients with a major risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal segmental glomerulosclerosis with nephrotic syndrome.
- •Patients with active psychosis
- •Patients who do not speak English.
- •Patients who live and will be followed outside the United States, except Canada.
- •Patients who are physically unable to open the Medication Event Monitoring System (MEMS) cap.
- •Patients who are not responsible for taking their own medications, e.g. living in a medical care facility.
- •Patients who are younger than 14 years old
- •Patients who will receive an extra renal organ (except pancreas), either simultaneously or previously.
结局指标
主要结局
Prediction of early medication adherence
时间窗: 3 months
Prediction of declining medication adherence during first three months post kidney transplantation.
次要结局
未报告次要终点