Adherence Enhancement for Renal Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- medication adherence
研究概览
简要总结
Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a "bundled" wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons > 21 years of age
- •first time recipient of a solitary kidney transplant
- •prescribed at least 3 medications for immunosuppression and hypertension
- •previous history of non-adherence
- •functioning kidney transplant
- •ability to speak, hear and understand English
- •able to use medication delivery device and self administer medications
- •able to operate blood pressure monitor
- •comfortable using cell phone
- •no other diagnosis that might shorten lifespan
- •transplant physician's assent that the patient can participate
排除标准
- •failure to meet all inclusion criteria
结局指标
主要结局
medication adherence
时间窗: 5 months
adherence to immunosuppressive medications
次要结局
- blood pressure(5 months)
研究者
John W. McGillicuddy
Associate Professor of Surgery
Medical University of South Carolina