New Ways to Help Patients Improve Their Diabetes Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01143870
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
University of Pennsylvania

May 17, 2010
June 14, 2010
January 11, 2016
February 28, 2018
February 28, 2018
April 2010
July 2011   (Final data collection date for primary outcome measure)
Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment [ Time Frame: 6 months from enrollment ]
Change in hemoglobin A1C 6 months following enrollment [ Time Frame: 6 months from enrollment ]
Complete list of historical versions of study NCT01143870 on Archive Site
  • Change in Patient Understanding of Disease State [ Time Frame: 2 weeks on average ]
    Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention.
  • The Number of Hemoglobin A1C Values Checked During 6 Month Study Period [ Time Frame: 6 months ]
  • Change in Hemoglobin A1C Over 12 Months From Enrollment [ Time Frame: 12 months ]
Same as current
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New Ways to Help Patients Improve Their Diabetes Control
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
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.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
Other: "Diabetes Report Card"
Enrolled participants will receive an individualized "diabetes report card" which depicts their current level of diabetes control in one of three ways--hemoglobin A1C, face, or letter grade.
  • Hemoglobin A1C
    Diabetes control related to patients using standard hemoglobin A1C
    Intervention: Other: "Diabetes Report Card"
  • Experimental: Face
    Face expressing emotion used to depict diabetes control
    Intervention: Other: "Diabetes Report Card"
  • Experimental: Letter grade
    Letter grade used to express diabetes control
    Intervention: Other: "Diabetes Report Card"
Gopalan A, Tahirovic E, Moss H, Troxel AB, Zhu J, Loewenstein G, Volpp KG. Translating the hemoglobin A1C with more easily understood feedback: a randomized controlled trial. J Gen Intern Med. 2014 Jul;29(7):996-1003. doi: 10.1007/s11606-014-2810-4. Epub 2014 Feb 25.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

1. 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.

Exclusion Criteria:

  1. Pregnant patients
  2. Illiterate patients
  3. Patients with known cognitive deficits affecting ability to participate in study
  4. Any current participants in another active research study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Pennsylvania
University of Pennsylvania
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Principal Investigator: Kevin Volpp, M.D., PhD University of Pennsylvania
University of Pennsylvania
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP