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Improving Diabetes Outcomes: a Couples Intervention

Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. This is a study to develop and test an intervention that helps partners and patients who have type 2 diabetes better support each other. The intervention will be delivered over the telephone to reach more people. Our hypothesis is that an intervention that targets the couple has a greater effect on health and well-being of patients than one that targets the individual patient alone.

研究概览

详细说明

Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. This is a pilot proposal to develop and test an intervention that aims to both enlist the support of partners of diabetes patients, and enhance and improve the quality of that support. We believe that the intervention will help the relationship and also will have a positive impact on medical (e.g.,blood sugar control), behavioral (e.g., increased exercise, better diet) and emotional (e.g., depression) outcomes. The intervention will be implemented by telephone, in order to enhance the project's ability to reach a broader sample of patients.Forty-five couples will be recruited in which one partner has type 2 diabetes. After initial testing and basic diabetes education, they will be assigned to one of three comparison groups. For those in the intervention groups they will participate in 11 telephone contacts with a diabetes educator and a counselor and will receive education about diabetes, behavior change, emotional issues/couples communication, and problem solving techniques. A manual will include readings, structured homework assignments, and self-monitoring logs. They will be re-tested 2 weeks and 3 months after the intervention.

研究类型

介入性

注册 (预期的)

45

阶段

  • 阶段1

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

    • New York
      • Syracuse、New York、美国、13210
        • State University of New York Upstate Medical 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

21年 至 95年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • greater than 21 years of age.
  • diagnosed with type 2 diabetes for at least 1 year.
  • have no severe complications (on dialysis, blindness, amputations, history of stroke)
  • able to speak, read and hear English.
  • married or cohabiting for > 1 year.
  • have a telephone.

Exclusion Criteria:

  • have a diagnosed psychiatric disorder.
  • refuse audiotaping or other study procedures.

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:治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:1
Telephone support and behavior change for couples
Diabetes self-management education provided over the telephone either for individuals or couples
有源比较器:2
Telephone support and behavior change for individuals
Diabetes self-management education provided over the telephone either for individuals or couples
安慰剂比较:3
Limited diabetes self-management education
通过电话提供有限的糖尿病自我管理教育,作为增强的常规护理控制干预

研究衡量的是什么?

主要结果指标

结果测量
大体时间
blood glucose control (hemoglobin A1c)
大体时间:2 and 14 weeks post
2 and 14 weeks post
blood pressure
大体时间:2 and 14 weeks post
2 and 14 weeks post
diabetes regimen adherence
大体时间:at 2 and 14 weeks post
at 2 and 14 weeks post

次要结果测量

结果测量
大体时间
lipids
大体时间:at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
weight/BMI
大体时间:at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
food habits
大体时间:at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
activity habits
大体时间:at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
health-related quality of life
大体时间:at 2 and 14 weeks post
at 2 and 14 weeks post
relationship quality
大体时间:at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention
diabetes self-efficacy
大体时间:at 2 and 14 weeks post intervention
at 2 and 14 weeks post intervention

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:Paula M Trief, PhD、State University of New York - Upstate Medical University

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

2006年1月1日

初级完成 (实际的)

2009年2月1日

研究完成 (实际的)

2009年2月1日

研究注册日期

首次提交

2005年11月7日

首先提交符合 QC 标准的

2005年11月7日

首次发布 (估计)

2005年11月8日

研究记录更新

最后更新发布 (估计)

2009年6月16日

上次提交的符合 QC 标准的更新

2009年6月15日

最后验证

2009年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1R34DK06799501A2

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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