Can Group Visits Improve Outcomes of Veterans With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00286741
First received: February 1, 2006
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: July 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes
Hypertension
Intervention: Other: Diabetes Group Management Visits

  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
Medical Group Visits

Medical group visits

Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.

Control control

Participant Flow:   Overall Study
    Medical Group Visits     Control  
STARTED     133     106  
COMPLETED     122     89  
NOT COMPLETED     11     17  



  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.
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Reporting Groups
  Description
Arm 1

Medical group visits

Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.

Arm 2 control
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  133     106     239  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 9.4     60.8  ± 10     62.0  ± 9.8  
Gender  
[units: participants]
     
Female     6     4     10  
Male     127     102     229  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     72     71     143  
White     57     29     86  
More than one race     0     0     0  
Unknown or Not Reported     4     6     10  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     3     2     5  
Not Hispanic or Latino     128     103     231  
Unknown or Not Reported     2     1     3  



  Outcome Measures
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1.  Primary:   Hemoglobin A1c, Systolic Blood Pressure   [ Time Frame: 12 months ]

2.  Primary:   Systolic Blood Pressure   [ Time Frame: 12 months ]

3.  Secondary:   Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).   [ Time Frame: one year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: David Edelman
Organization: Durham VA Medical Center
phone: 919-286-6936
e-mail: dedelman@duke.edu


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00286741     History of Changes
Other Study ID Numbers: IIR 03-084
Study First Received: February 1, 2006
Results First Received: July 31, 2014
Last Updated: September 3, 2014
Health Authority: United States: Federal Government