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OpenTrials
Completed

NCT Number: NCT01143870

New Ways to Help Patients Improve Their 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

"Diabetes Report Card"

Other

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.

Primary outcomes

  1. Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment

    Time frame: 6 months from enrollment

Secondary outcomes

  1. 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.

  2. The Number of Hemoglobin A1C Values Checked During 6 Month Study Period

    Time frame: 6 months

  3. Change in Hemoglobin A1C Over 12 Months From Enrollment

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2010
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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