New Ways to Help Patients Improve Their Diabetes Control
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus |
Other: "Diabetes Report Card" |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Change in hemoglobin A1C 6 months following enrollment [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
- Change in patient understanding of disease state [ Time Frame: 2 weeks on average ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in hemoglobin A1C over 12 months from enrollment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 177 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Hemoglobin A1C
Diabetes control related to patients using standard hemoglobin A1C
|
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.
|
|
Experimental: Face
Face expressing emotion used to depict 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.
|
|
Experimental: Letter grade
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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:
- Pregnant patients
- Illiterate patients
- Patients with known cognitive deficits affecting ability to participate in study
- Any current participants in another active research study
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Kevin Volpp, M.D., PhD | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Dr. Kevin Volpp, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01143870 History of Changes |
| Other Study ID Numbers: | 811355 |
| Study First Received: | May 17, 2010 |
| Last Updated: | January 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013