Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events (composite endpoint)
研究概览
简要总结
Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all eligible patients with follow-up at our outpatient clinic
- •written informed consent
- •sufficient German language skills to read and answer a battery of questionnaires
- •> 18 years
- •minimum 6 mts post HTX
排除标准
- •illiteracy
研究组 & 干预措施
1
intervention group
干预措施: behavioral adaptation and symptom management (Behavioral)
2
control group
结局指标
主要结局
Occurrence of adverse events (composite endpoint)
时间窗: at month 60
次要结局
- Adherence behavior measurement variables from MEMS system(first 3 month)
- Immunosuppression level(at month 60)
- All individual components of the composite endpoint occurence of adverse events(at month 60)
- Immunosuppression level(Month 3, 12 and 60)
- Immunosuppression level(month 12)