Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation (SMP-NEP)
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
研究概览
地位
详细说明
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.
Design: Randomised controlled trial, not blinded
Setting and time: The study will take place at the Nephrology Clinic, University Hospital Zürich, from 1 May 2012 through 31 April 2015.
Variables and Measurement: Physical, behavioural, and clinical outcomes will be measured at baseline, before randomization and then 8 and 12 months later. Medication adherence, physical activity, symptoms of depression and anxiety, quality of life and patients' perception of health care provided will be measured with validated questionnaires. Body weight, height, waist to hip ratio and body composition (BCM Fresenius) will be measured at the Nephrology Clinic. Physical activity will be measured with the pedometer StepWatchTM.
Intervention
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Zurich、瑞士、8091
- University Hospital Zurich
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- received a kidney or a kidney-pancreas transplant in the University Hospital Zürich
Exclusion Criteria:
- unstable psychiatric disorder
- cognitive impairment
- multi-organ transplantation with lung
- liver or heart
- illiteracy
- not able to speak and understand German
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:控制
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Session takes place within the first three months after transplantation
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实验性的:Intervention
The intensity of the intervention follows a defined algorithm during the first eight months after renal transplantation. Behaviours are classified in three groups:
All patients (group 1-3) will receive an assessment, education and a monthly reassessment. Patients from group 2 und 3 will receive additionally behavioral education and peer involvement. Patients from group 3 will receive additionally a consilium of specialized healthcare professionals such as a nutritionist, physiotherapist, or psychologist. |
Patients participate in 9 sessions during the first 8th month after transplantaiton
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change from baseline BMI at 8 months
大体时间:8th month
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BMI
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8th month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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difference of activity between control and intervention group at month 8
大体时间:month 8
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differences in steps measured with pedometer (Stepwatch)
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month 8
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difference of activity between control and intervention group at month 12
大体时间:month 12
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differences in steps measured with pedometer (Stepwatch)
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month 12
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change from baseline BMI at 12 months
大体时间:12th month
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BMI
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12th month
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difference of self-reported adherence between control and intervention group at month 8
大体时间:month 8
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month 8
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difference of self-reported adherence between control and intervention group at month 12
大体时间:month 12
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month 12
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change from baseline LTM at 8 months
大体时间:8 months
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LTM measured with Body Composition Analysis
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8 months
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change from baseline LTM at 12 months
大体时间:12 months
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LTM measured with Body Composition Analysis
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12 months
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合作者和调查者
调查人员
- 首席研究员:Rebecca Spirig, PHD, RN、Nursing Director, Head Office of Nursing and Allied Health Professionals
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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