New Ways to Help Patients Improve Their Diabetes Control

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Diabetes Report Card


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Pregnant patients Illiterate patients Patients with known cognitive deficits affecting ability to participate in study Any current participants in another active research study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hemoglobin A1C<br>Diabetes control related to patients using standard hemoglobin A1C | Other: Diabetes Report Card<br>* 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.<br>|
| Experimental: Face<br>Face expressing emotion used to depict diabetes control | Other: Diabetes Report Card<br>* 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.<br>|
| Experimental: Letter grade<br>Letter grade used to express diabetes control | Other: Diabetes Report Card<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment |  | 6 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Understanding of Disease State | Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention. | 2 weeks on average | 
| The Number of Hemoglobin A1C Values Checked During 6 Month Study Period |  | 6 months | 
| Change in Hemoglobin A1C Over 12 Months From Enrollment |  | 12 months |