Diabetes Scorecard Educational Intervention Study

August 10, 2017 updated by: Michael Irwig, George Washington University

Use of a Card to Improve Risk Factor Control in Patients With Type II Diabetes

The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20037
        • Medical Faculty Associates, George Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Uncontrolled Type II diabetes (HbA1c ≥ 8%)

Exclusion Criteria:

  • Type I Diabetes
  • HbA1c < 8%
  • Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier
  • Pregnancy
  • Planning to move within the next year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scorecard
Score of points for variables.
Behavioral: Scorecard
Points were assigned for blood pressure, HbA1c level, LDL-cholesterol level, aspirin use and exercise level.
Behavioral: Control
Standard of care for diabetes subjects
No Intervention: Control
Standard of care for diabetes subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total score
Time Frame: 9 months
The total score was calculated by points assigned to variables (systolic blood pressure, diastolic blood pressure, HbA1c, aspirin usage and daily exercise). The maximal score of 100 corresponds to all variables at target. Fewer points were assigned to higher blood pressure, worse HbA1c levels, less exercise, etc.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-cholesterol
Time Frame: 9 months
9 months
HbA1c
Time Frame: 9 months
Measure of glycemic control
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiabetesScorecardStudy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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