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New Ways to Help Patients Improve Their Diabetes Control

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ClinicalTrials.gov Identifier: NCT01143870
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Intervention: Other: "Diabetes Report Card"

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Received information on diabetes control using the standard hemoglobin A1c value
Letter Grades Received information on diabetes control translated into a letter grade, ranging from A-F
Faces Received information on diabetes control translated into a emoticon, ranging from smiling to crying

Participant Flow:   Overall Study
    Control   Letter Grades   Faces
STARTED   58   58   61 
Post-intervention Survey   53   50   61 
Had Available 6-month A1C   27   29   31 
A1C Imputed   31   29   30 
COMPLETED   58   58   61 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Received information on diabetes control using the standard hemoglobin A1c value
Letter Grades Received information on diabetes control translated into a letter grade, ranging from A-F
Faces Received information on diabetes control translated into a emoticon, ranging from smiling to crying
Total Total of all reporting groups

Baseline Measures
   Control   Letter Grades   Faces   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   58   61   177 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.6  (3.3)   57.8  (3.1)   55  (3.5)   56.4  (1.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      41  70.7%      45  77.6%      44  72.1%      130  73.4% 
Male      17  29.3%      13  22.4%      17  27.9%      47  26.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      48  82.8%      50  86.2%      48  78.7%      146  82.5% 
White      2   3.4%      2   3.4%      4   6.6%      8   4.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      8  13.8%      6  10.3%      9  14.8%      23  13.0% 


  Outcome Measures

1.  Primary:   Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment   [ Time Frame: 6 months from enrollment ]

2.  Secondary:   Change in Patient Understanding of Disease State   [ Time Frame: 2 weeks on average ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   The Number of Hemoglobin A1C Values Checked During 6 Month Study Period   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in Hemoglobin A1C Over 12 Months From Enrollment   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anjali Gopalan
Organization: University of Pennsylvania
phone: 575-640-3893
e-mail: agopalan@upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01143870     History of Changes
Other Study ID Numbers: 811355
First Submitted: May 17, 2010
First Posted: June 14, 2010
Results First Submitted: January 11, 2016
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018