Diabetes Mellitus
Conditions
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.
Interventions
OTHERDiabetes 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment | 6 months from enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Understanding of Disease State | 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 | 6 months | — |
| Change in Hemoglobin A1C Over 12 Months From Enrollment | 12 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Received information on diabetes control using the standard hemoglobin A1c value | 58 |
| Letter Grades Received information on diabetes control translated into a letter grade, ranging from A-F | 58 |
| Faces Received information on diabetes control translated into a emoticon, ranging from smiling to crying | 61 |
| Total | 177 |
Baseline characteristics
| Characteristic | Control | Letter Grades | Faces | Total |
|---|---|---|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 3.3 | 57.8 years STANDARD_DEVIATION 3.1 | 55 years STANDARD_DEVIATION 3.5 | 56.4 years STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 50 Participants | 48 Participants | 146 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 6 Participants | 9 Participants | 23 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 41 Participants | 45 Participants | 44 Participants | 130 Participants |
| Sex: Female, Male Male | 17 Participants | 13 Participants | 17 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 58 | 0 / 61 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 | 0 / 61 |
Outcome results
Primary
Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment
Time frame: 6 months from enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment | -0.74 Percent of glycosylated hemoglobin | Standard Error 0.37 |
| Letter Grades | Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment | -0.55 Percent of glycosylated hemoglobin | Standard Error 0.3 |
| Faces | Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment | -0.89 Percent of glycosylated hemoglobin | Standard Error 0.3 |
Secondary
Change in Hemoglobin A1C Over 12 Months From Enrollment
Time frame: 12 months
Secondary
Change in Patient Understanding of Disease State
Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention.
Time frame: 2 weeks on average
Secondary
The Number of Hemoglobin A1C Values Checked During 6 Month Study Period
Time frame: 6 months