An interventional study of "Diabetes Report Card" in Diabetes Mellitus, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 177 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diabetes control related to patients using standard hemoglobin A1C
Other: "Diabetes Report Card"
Face expressing emotion used to depict diabetes control
Other: "Diabetes Report Card"
Letter grade used to express diabetes control
Other: "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.
Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment
Time frame: 6 months from enrollment
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
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
| Milestone | Control | Letter Grades | Faces |
|---|---|---|---|
| Started | 58 | 58 | 61 |
| Post-intervention survey | 53 | 50 | 61 |
| Had available 6-month a1c | 27 | 29 | 31 |
| A1c imputed | 31 | 29 | 30 |
| Completed | 58 | 58 | 61 |
| Not completed | 0 | 0 | 0 |
| Percent of glycosylated hemoglobin | Control | Letter Grades | Faces |
|---|---|---|---|
| Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment | -0.74 ± 0.37 | -0.55 ± 0.3 | -0.89 ± 0.3 |
Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/58 (0%) | 0/58 (0%) |
| Letter Grades | — | 0/58 (0%) | 0/58 (0%) |
| Faces | — | 0/61 (0%) | 0/61 (0%) |
| Age, Continuous(years) | Control | Letter Grades | Faces | Total |
|---|---|---|---|---|
| Mean | 56.6 ± 3.3 | 57.8 ± 3.1 | 55 ± 3.5 | 56.4 ± 1.9 |
| Sex: Female, Male(Participants) | Control | Letter Grades | Faces | Total |
|---|---|---|---|---|
| Female | 41 | 45 | 44 | 130 |
| Male | 17 | 13 | 17 | 47 |
| Race (NIH/OMB)(Participants) | Control | Letter Grades | Faces | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 48 | 50 | 48 | 146 |
| White | 2 | 2 | 4 | 8 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 6 | 9 | 23 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pennsylvania