New Ways to Help Patients Improve Their Diabetes Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01143870
First received: May 17, 2010
Last updated: January 3, 2011
Last verified: June 2010

May 17, 2010
January 3, 2011
April 2010
October 2010   (final data collection date for primary outcome measure)
Change in hemoglobin A1C 6 months following enrollment [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01143870 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
New Ways to Help Patients Improve Their Diabetes Control
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
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.
  • Hemoglobin A1C
    Diabetes control related to patients using standard hemoglobin A1C
    Intervention: Other: "Diabetes Report Card"
  • Experimental: Face
    Face expressing emotion used to depict diabetes control
    Intervention: Other: "Diabetes Report Card"
  • Experimental: Letter grade
    Letter grade used to express diabetes control
    Intervention: Other: "Diabetes Report Card"
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
177
March 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01143870
811355
No
Dr. Kevin Volpp, University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Kevin Volpp, M.D., PhD University of Pennsylvania
University of Pennsylvania
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP