Improving Diabetes Outcome: The Diabetes Support Project
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 4
- 主要终点
- Blood glucose control (hemoglobin AIc)
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. The purpose of this study is to 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
Diabetes is a serious illness that affects an estimated 7% of the US population, and is associated with life-threatening and disabling complications. Research has shown that diabetes affects both the patient and family, and that support from one's spouse has been found to be the most important source of support during illness episodes. Research clearly shows that marital interaction, i.e., how the support is given and received, impacts both marital quality and health functioning. Despite the acknowledged importance of social support, the vast majority of chronic illness interventions target the individual patient. Telephone counseling has been effectively used to enhance feasibility and target patients with many illnesses, and has many benefits including low cost, decreased subject burden, and the ability to reach a broader population. This study proposes a study of a telephone-administered behavior change that promotes couples communication and collaboration.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes
- •A1c level is >=7.5%
- •Age of target subject and spouse/partner is 21 years or older
- •Married or together for > 1 year
- •Able to speak, read, and hear English
- •Have a telephone
排除标准
- •History of diabetes-related medical complications
- •History of active psychosis or dementia
结局指标
主要结局
Blood glucose control (hemoglobin AIc)
时间窗: Baseline, and 3 follow ups (mos 4, 8, 12)
次要结局
- BMI/Waist circumference(Baseline and 3 follow-ups (mos 4, 8, and 12))
- Diabetes-related quality of life outcome (distress)(Baseline and 3 follow-ups (mos 4, 8, and 12))
- Measures of behavior change (diet, physical activity)(Baseline and 3 follow-ups (mos 4, 8, and 12))
研究者
Paula Trief
Professor of Psychiatry and Medicine
State University of New York - Upstate Medical University