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临床试验/NCT01143870
NCT01143870已完成不适用

Examining Ways to Increase Patient Understanding of Diabetes Control and Disease Severity Through Reinterpretation of Hemoglobin A1C Values With the Goal of Improved Diabetes Control

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2010年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
177
试验地点
2
主要终点
Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment

研究概览

简要总结

The percent of glycosylated hemoglobin, also known as a hemoglobin A1C value, is the standard way that clinicians assess a patient's diabetes control. Numerous studies have shown that maintaining a hemoglobin A1C value less than 7% is associated with lower rates of diabetes-related complications. Clinicians use this value to determine whether a patient with diabetes requires changes in their disease management. The main problem with this practice is that many patients do not understand what this number means. The goal of this project is to examine ways to make feedback about glycemic control easier for patients to understand. The hope is that improved patient understanding will result in an improvement in diabetic control and thus a reduction in disease-associated complications. Patients with a diagnosis of diabetes and a hemoglobin A1C value greater than 8% within the preceding three months will be eligible for the study. Pregnant women will be excluded. Given the nature of the intervention we will also exclude patients with cognitive deficits. In this study, patients will be randomized to three groups. The first group with be told their HgbA1C value only, the second group will be told a letter grade interpretation of that value, and the third group will be shown a face. The face emotions will range from happy to sad reflecting the level of control. The main outcome will be trend in hemoglobin A1C values over time. Secondary outcomes will include patient understanding of disease state and the number of hemoglobin A1C values checked following the intervention.

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
None

入排标准

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

入选标准

  • Patients over the age of 18 with diabetes mellitus listed as a problem list or in their past medical history on their electronic medical record who have a hemoglobin A1C value greater than 8% within three months of study enrollment.

排除标准

  • Pregnant patients
  • Illiterate patients
  • Patients with known cognitive deficits affecting ability to participate in study
  • Any current participants in another active research study

研究组 & 干预措施

Hemoglobin A1C

Other

Diabetes control related to patients using standard hemoglobin A1C

干预措施: "Diabetes Report Card" (Other)

Face

Experimental

Face expressing emotion used to depict diabetes control

干预措施: "Diabetes Report Card" (Other)

Letter grade

Experimental

Letter grade used to express diabetes control

干预措施: "Diabetes Report Card" (Other)

结局指标

主要结局

Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment

时间窗: 6 months from enrollment

次要结局

  • The Number of Hemoglobin A1C Values Checked During 6 Month Study Period(6 months)
  • Change in Patient Understanding of Disease State(2 weeks on average)
  • Change in Hemoglobin A1C Over 12 Months From Enrollment(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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