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Empowering Patients to Better Manage Diabetes Through Self-Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00254501
First Posted: November 16, 2005
Last Update Posted: July 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dale F Kraemer, University of Florida
Results First Submitted: July 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Type I or Type II Diabetes (Excludes Gestational Diabetes)
Interventions: Behavioral: Pharmacist Counseling
Behavioral: Educational materials

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Usual Care Plus Out-of-pocket Cost Waiver Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
EMPOWER Group Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.

Participant Flow:   Overall Study
    Usual Care Plus Out-of-pocket Cost Waiver   EMPOWER Group
STARTED   32   37 
COMPLETED   31   36 
NOT COMPLETED   1   1 
Lost to Follow-up                1                1 



  Baseline Characteristics
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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
Usual Care Plus Out-of-pocket Cost Waiver Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
EMPOWER Group Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
Total Total of all reporting groups

Baseline Measures
   Usual Care Plus Out-of-pocket Cost Waiver   EMPOWER Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   36   67 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.6  (9.2)   55.6  (6.8)   54.2  (8.1) 
Gender 
[Units: Participants]
     
Female   19   14   33 
Male   12   22   34 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   2   2 
Not Hispanic or Latino   31   34   65 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   1   2 
Asian   2   0   2 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   0   1   1 
White   30   32   62 
More than one race   2   0   2 
Unknown or Not Reported   0   0   0 
Education categories 
[Units: Participants]
     
High school graduate   5   4   9 
Some college   17   15   32 
College graduate   8   11   19 
At least a masters degree   0   3   3 
Unspecified   1   3   4 
Income categories 
[Units: Participants]
     
$15 000 to <$30 000   3   3   6 
$30 000 to <$50 000   11   12   23 
$50 000 to <$100 000   11   10   21 
$100 000 or more   2   10   12 
Unspecified   4   1   5 
Hypertension 
[Units: Participants]
     
Yes   16   26   42 
No   15   10   25 
Dyslipidemia 
[Units: Participants]
     
Yes   16   25   41 
No   15   11   26 
Depression 
[Units: Participants]
     
Yes   10   6   16 
No   21   30   51 
On glucose-lowering therapy 
[Units: Participants]
     
Yes   24   28   52 
No   7   8   15 
On oral agents 
[Units: Participants]
     
Yes   20   24   44 
No   11   12   23 
On insulin 
[Units: Participants]
     
Yes   10   5   15 
No   21   31   52 
On other diabetes medications 
[Units: Participants]
     
Yes   2   3   5 
No   29   33   62 
Used diabetic supplies 
[Units: Participants]
     
Yes   18   10   28 
No   13   26   39 
Years since diabetes diagnosis 
[Units: Years]
Mean (Standard Deviation)
 8.0  (7.4)   9.9  (10.3)   9.0  (9.1) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Hemoglobin A-1C From Baseline   [ Time Frame: baseline and 12 months ]

2.  Secondary:   Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides   [ Time Frame: baseline and 12 months ]

3.  Secondary:   Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months   [ Time Frame: baseline to 12 months ]

4.  Secondary:   Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months   [ Time Frame: From baseline to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dale Kraemer
Organization: University of Florida
e-mail: Dale.Kraemer@jax.ufl.edu


Publications of Results:

Responsible Party: Dale F Kraemer, University of Florida
ClinicalTrials.gov Identifier: NCT00254501     History of Changes
Other Study ID Numbers: OSU_COP_PP_0105
IRB Application 2979
First Submitted: November 14, 2005
First Posted: November 16, 2005
Results First Submitted: July 14, 2016
Results First Posted: July 22, 2016
Last Update Posted: July 22, 2016