此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

The Effects of Self-management Education Based on Theory of Planned Behavior on Patients With Type 2 Diabetes

2016年10月24日 更新者：FangFang Zhao、University of Turku

The Effects of Self-management Education Based on Theory of Planned Behavior on Self-management and Quality of Life of Patients With Type 2 Diabetes and the Other Influencing Factors of Quality of Life

The aims of the study are as follows:

  • To improve self-management intention and behavior of patients with type 2 diabetes (T2 DM).
  • To promote patients to make plans for their self-management and gradually integrate the self-management plan into their daily life.
  • To improve resilience, well-being, fatigue and quality of life of patients with T2 DM

In order to achieve the aims, we have set the following objectives:

  • To develop and apply self-management education program based on the extended theory of planned behavior.

  • To evaluate the efficacy of the educational program:

    1. Self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).

研究概览

地位

暂停

条件

干预/治疗

详细说明

This study employs a quasi-experimental study design with an intervention and comparison group and follow-up of 3 months; there will be two measuring points (baseline and 3 months after the intervention) , and 9 measures.

研究类型

介入性

注册 (预期的)

280

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

  • 中国
    • Jiangsu
      • Nantong、Jiangsu、中国、226001
        • The First People Hospital, Affiliated hospital of Nantong University

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 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. age ≥18 years
  2. duration of type 2 diabetes ≥3 months
  3. without any severe complication and impaired cognition.

Exclusion criteria are:

  1. severe physical handicap or mental illness
  2. presence of other serious disease such as cancer and stroke.

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：支持治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental group
Intervention is administered to patients in this Arm. The intervention is self-management education based on the theory of planned behavior(TPB). The intervention of experimental group is individual guide and face to face education based on TPB.
行为的：Self-management education
The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .
有源比较器：Comparison group
The comparison group will receive routine care
行为的：Routine care
They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital

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 in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
大体时间：baseline and at three months.
Measure the impact and important of 19 life domains.
baseline and at three months.

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in Fatigue-14 scale at 3-month follow up.
大体时间：Baseline,3-month follow up.
Baseline,3-month follow up.
Change from baseline in Well-Being Index (WHO-5)
大体时间：Baseline,3-month follow up.
Baseline,3-month follow up.
Change from baseline in The Summary of Diabetes Self-Care Activities Measure at 3-month follow up.
大体时间：Baseline,3-month follow up.
The scale include diet, exercise, medication, foot care and blood sugar monitoring
Baseline,3-month follow up.
Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.
大体时间：Baseline,3-month follow up.
It is based on theory of planned behavior according to the following guideline. Including attitude, subjective norm, perceived behavior control, intention and behavior, action planning and coping planning.The response used likert 1-7 format.
Baseline,3-month follow up.
Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.
大体时间：Baseline,3-month follow up.
Baseline,3-month follow up.
Change from baseline in HbA1c at 3-month follow up.
大体时间：Baseline, 3-month follow up.
HbA1c will be measured at outpatient of hospital.
Baseline, 3-month follow up.
Change from baseline in BMI at 3-month follow up.
大体时间：Baseline,3-month follow up.
BMI will be measured at hospital and participants' home.
Baseline,3-month follow up.
Change from baseline in Blood sugar at 3-month follow up.
大体时间：Baseline,3-month follow up.
Blood sugar will be measured at hospital and participants' home.
Baseline,3-month follow up.

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。

赞助

University of Turku

调查人员

  • 学习椅：Helena leino-kilpi, PhD、Department of Nursing Science, Universtiy of Turku

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。

一般刊物

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

2015年7月1日

初级完成 (预期的)

2017年6月1日

研究完成 (预期的)

2019年12月1日

研究注册日期

首次提交

2015年10月27日

首先提交符合 QC 标准的

2015年10月31日

首次发布 (估计)

2015年11月3日

研究记录更新

最后更新发布 (估计)

2016年10月25日

上次提交的符合 QC 标准的更新

2016年10月24日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BK2014011

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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.

订阅