New Ways to Help Patients Improve Their Diabetes Control

University of Pennsylvania

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: "Diabetes Report Card"

Study type: Interventional

Funder types: Other

Identifiers

NCT01143870

811355

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

177 participants in 3 patient groups

Hemoglobin A1C

Other group

Description:

Diabetes control related to patients using standard hemoglobin A1C

Treatment:

Other: "Diabetes Report Card"

Face

Experimental group

Description:

Face expressing emotion used to depict diabetes control

Treatment:

Other: "Diabetes Report Card"

Letter grade

Experimental group

Description:

Letter grade used to express diabetes control

Treatment:

Other: "Diabetes Report Card"