Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatment "diabetes report card"
Sponsor University of Pennsylvania
Start date April 2010
End date October 2010
Trial size 177 participants
Trial identifier NCT01143870, 811355

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Diabetes control related to patients using standard hemoglobin A1C
"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.
(Experimental)
Face expressing emotion used to depict diabetes control
"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.
(Experimental)
Letter grade used to express diabetes control
"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.

Primary Outcomes

Measure
Change in hemoglobin A1C 6 months following enrollment
time frame: 6 months from enrollment

Secondary Outcomes

Measure
Change in patient understanding of disease state
time frame: 2 weeks on average
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official 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
Principal investigator Kevin Volpp, M.D., PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by University of Pennsylvania.