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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
  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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in hemoglobin A1C 6 months following enrollment [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143870

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kevin Volpp, M.D., PhD University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014