Empowering Patients to Better Manage Diabetes Through Self-Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Change in Hemoglobin A-1C From Baseline
研究概览
简要总结
This study will look at the impact of health insurance benefits on self management of diabetes for people with this condition. Studies have shown that when people with diabetes manage their disease better, they stay healthier. Our goal in this study is to help those with diabetes better manage their disease (self-care). We will compare two types of health insurance benefits in this study. We want to see if one set of benefits improves self-care more than the other one.
详细描述
The objective of this particular study is to determine if the addition of regular pharmacist visits to usual care can improve clinical outcomes in patients with diabetes. The central hypothesis is that a program overseen by community pharmacists that empowers patients to self-manage their diabetes will lead to improved clinical and humanistic outcomes and will be cost-effective. Strong preliminary data collected from other sites suggests that patient empowerment programs are effective at reducing hemoglobin A1C after 12 months and in reducing the total cost of care. This hypothesis will be tested by pursuing three specific aims to evaluate the impact of a pharmacist-administered diabetes patient empowerment program on:
- clinical markers for diabetes and related metabolic disorders;
- the cost of care and resource utilization; and
- patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes (Type I or Type II)
- •enrolled in health plan with participating employer
- •age 18 or older
- •willing and able to provide informed consent
排除标准
- •gestational diabetes
结局指标
主要结局
Change in Hemoglobin A-1C From Baseline
时间窗: baseline and 12 months
Compare changes in Hemoglobin A-1C from baseline between the two groups.
次要结局
- Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months(From baseline to 12 months)
- Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides(baseline and 12 months)
- Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months(baseline to 12 months)
研究者
Dale F Kraemer
Associate Professor
University of Florida