New Ways to Help Patients Improve Their Diabetes Control
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 17, 2010 | ||||
| Last Updated Date | January 3, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in hemoglobin A1C 6 months following enrollment [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01143870 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | New Ways to Help Patients Improve Their Diabetes Control | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diabetes Mellitus | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 177 | ||||
| Estimated Completion Date | March 2011 | ||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01143870 | ||||
| Other Study ID Numbers ICMJE | 811355 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Kevin Volpp, University of Pennsylvania | ||||
| Study Sponsor ICMJE | University of Pennsylvania | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pennsylvania | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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