New Ways to Help Patients Improve Their Diabetes Control

NCT01143870 | Completed Results

• 1 other identifier: 811355
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment

  6 months from enrollment

Secondary Outcomes (3)

• Change in Patient Understanding of Disease State

  2 weeks on average

• 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

Study Arms (3)

Hemoglobin A1C

OTHER

Diabetes control related to patients using standard hemoglobin A1C

Other: "Diabetes Report Card"

Face

EXPERIMENTAL

Face expressing emotion used to depict diabetes control

Other: "Diabetes Report Card"

Letter grade

EXPERIMENTAL

Letter grade used to express diabetes control

Other: "Diabetes Report Card"

Interventions

"Diabetes Report Card" OTHER

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.

Face; Hemoglobin A1C; Letter grade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Pregnant patients
• Illiterate patients
• Patients with known cognitive deficits affecting ability to participate in study
• Any current participants in another active research study

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Gopalan A, Tahirovic E, Moss H, Troxel AB, Zhu J, Loewenstein G, Volpp KG. Translating the hemoglobin A1C with more easily understood feedback: a randomized controlled trial. J Gen Intern Med. 2014 Jul;29(7):996-1003. doi: 10.1007/s11606-014-2810-4. Epub 2014 Feb 25.

  PMID: 24567202 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Anjali Gopalan
• Organization: University of Pennsylvania

agopalan@upenn.edu

575-640-3893

Study Officials

• Kevin Volpp, M.D., PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: June 14, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 28, 2018
• Results First Posted: February 28, 2018

Record last verified: 2018-02

Locations

US (1)