New Ways to Help Patients Improve Their Diabetes Control

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: "Diabetes Report Card"

• Registration Number: NCT01143870
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2016-01-11
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-26
• Last Update Submitted: 2018-02-26
• Results First Posted: 2018-02-28
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letter grade	"Diabetes Report Card"	Letter grade used to express diabetes control
Hemoglobin A1C	"Diabetes Report Card"	Diabetes control related to patients using standard hemoglobin A1C
Face	"Diabetes Report Card"	Face expressing emotion used to depict diabetes control

Primary Outcome Measures

Name	Time	Method
Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment	6 months from enrollment

Secondary Outcome Measures

Name	Time	Method
The Number of Hemoglobin A1C Values Checked During 6 Month Study Period	6 months
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.
Change in Hemoglobin A1C Over 12 Months From Enrollment	12 months

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States