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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoglobin A1C | Other | Diabetes control related to patients using standard hemoglobin A1C |
|
| Face | Experimental | Face expressing emotion used to depict diabetes control |
|
| Letter grade | Experimental | Letter grade used to express diabetes control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment | 6 months from enrollment |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Volpp, M.D., PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24567202 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Received information on diabetes control using the standard hemoglobin A1c value |
| FG001 | Letter Grades | Received information on diabetes control translated into a letter grade, ranging from A-F |
| FG002 | Faces | Received information on diabetes control translated into a emoticon, ranging from smiling to crying |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Received information on diabetes control using the standard hemoglobin A1c value |
| BG001 | Letter Grades | Received information on diabetes control translated into a letter grade, ranging from A-F |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment | Posted | Mean | Standard Error | Percent of glycosylated hemoglobin | 6 months from enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Received information on diabetes control using the standard hemoglobin A1c value |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anjali Gopalan | University of Pennsylvania | 575-640-3893 | agopalan@upenn.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 6 months |
| Change in Hemoglobin A1C Over 12 Months From Enrollment | 12 months |
| BG002 | Faces | Received information on diabetes control translated into a emoticon, ranging from smiling to crying |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Change in Patient Understanding of Disease State | Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention. | Not Posted | 2 weeks on average | Participants |
| Secondary | The Number of Hemoglobin A1C Values Checked During 6 Month Study Period | Not Posted | 6 months | Participants |
| Secondary | Change in Hemoglobin A1C Over 12 Months From Enrollment | Not Posted | 12 months | Participants |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Letter Grades | 0 | 58 | 0 | 58 |
| EG002 | Faces | 0 | 61 | 0 | 61 |
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