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Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation (SMP-NEP)

2021年4月30日 更新者:University of Zurich

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

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.

研究概览

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:

  1. Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).
  2. Compare differences in the amount of physical exercise between subjects in the IG group and the CG.
  3. 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

介入性

注册 (实际的)

122

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Zurich、瑞士、8091
        • University Hospital Zurich

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
其他:控制
Session takes place within the first three months after transplantation
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:

  • Group 1: Patients with optimal behaviour in all three behaviours.
  • Group 2: Patients with slight deviation (defined) from optimal behaviour in one or more behaviours.
  • Group 3: Patients with larger deviation (defined) from optimal behaviour in one or more behaviours.

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

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
BMI
8th month

次要结果测量

结果测量
措施说明
大体时间
difference of activity between control and intervention group at month 8
大体时间:month 8
differences in steps measured with pedometer (Stepwatch)
month 8
difference of activity between control and intervention group at month 12
大体时间:month 12
differences in steps measured with pedometer (Stepwatch)
month 12
change from baseline BMI at 12 months
大体时间:12th month
BMI
12th month
difference of self-reported adherence between control and intervention group at month 8
大体时间:month 8
month 8
difference of self-reported adherence between control and intervention group at month 12
大体时间:month 12
month 12
change from baseline LTM at 8 months
大体时间:8 months
LTM measured with Body Composition Analysis
8 months
change from baseline LTM at 12 months
大体时间:12 months
LTM measured with Body Composition Analysis
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年5月1日

初级完成 (实际的)

2018年1月1日

研究完成 (实际的)

2018年2月1日

研究注册日期

首次提交

2014年10月27日

首先提交符合 QC 标准的

2014年11月3日

首次发布 (估计)

2014年11月4日

研究记录更新

最后更新发布 (实际的)

2021年5月3日

上次提交的符合 QC 标准的更新

2021年4月30日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • KEK-ZK-Nr. 2011-0411

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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