Effectiveness of an Advanced Practice Nurse-led Self-management Program on Prevention of Weight Gain, Physical Activity and Medication Adherence in Patients in the First Year After Renal Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- change from baseline BMI at 8 months
研究概览
简要总结
The aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. Physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later.
详细描述
Renal transplant recipients have to integrate preventive behaviours into their everyday lives. From the literature it is known that patients can only partially adhere to the recommended behaviours. An evidence-based self-management program to support patients in behaviour change was developed with a main focus on prevention of weight gain and increasing physical activity and medication adherence.
The aim of this study is to investigate the effectiveness of the program in patients in the first year after renal transplantation.
The specific aims of this study are:
- Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).
- Compare differences in the amount of physical exercise between subjects in the IG group and the CG.
- Compare differences in self-reported medication adherence between the subjects of the IG group and the CG.
Secondarily, differences in self-reported quality of life, anxiety and depression, and differences in patients' perception of health care provision regarding chronic illness between the subjects of the IG group and the CG will be compared.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •received a kidney or a kidney-pancreas transplant in the University Hospital Zürich
排除标准
- •unstable psychiatric disorder
- •cognitive impairment
- •multi-organ transplantation with lung
- •liver or heart
- •illiteracy
- •not able to speak and understand German
结局指标
主要结局
change from baseline BMI at 8 months
时间窗: 8th month
BMI
次要结局
- difference of activity between control and intervention group at month 8(month 8)
- difference of activity between control and intervention group at month 12(month 12)
- change from baseline BMI at 12 months(12th month)
- difference of self-reported adherence between control and intervention group at month 8(month 8)
- difference of self-reported adherence between control and intervention group at month 12(month 12)
- change from baseline LTM at 8 months(8 months)
- change from baseline LTM at 12 months(12 months)