跳至主要内容
临床试验/NCT00250731
NCT00250731已完成1 期

Improving Diabetes Outcomes: a Couples Intervention

State University of New York - Upstate Medical University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
blood glucose control (hemoglobin A1c)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

blood glucose control (hemoglobin A1c)

时间窗: 2 and 14 weeks post

blood pressure

时间窗: 2 and 14 weeks post

diabetes regimen adherence

时间窗: at 2 and 14 weeks post

次要结局

  • lipids(at 2 and 14 weeks post intervention)
  • weight/BMI(at 2 and 14 weeks post intervention)
  • food habits(at 2 and 14 weeks post intervention)
  • activity habits(at 2 and 14 weeks post intervention)
  • health-related quality of life(at 2 and 14 weeks post)
  • relationship quality(at 2 and 14 weeks post intervention)
  • diabetes self-efficacy(at 2 and 14 weeks post intervention)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other

研究点 (2)

Loading locations...

相似试验