Pharmacist-led Group Medical Visits to Help With Diabetes Management (MEDIC-1 year)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00554671
First received: November 5, 2007
Last updated: April 6, 2015
Last verified: October 2014
Results First Received: December 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Cardiovascular Diseases
Interventions: Other: Algorithm driven medication titration
Behavioral: Monitoring
Behavioral: Group support
Behavioral: Self efficacy

  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
Pharmacist-led Group Medical Visits

Pharmacist-led group medical visits which consists of medication titration and behavioral modification

Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes

Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals

Group support: Peer support are provided in the group setting

Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision

Usual Care Patients continued on usual care without pharmacist-led group medical visits

Participant Flow:   Overall Study
    Pharmacist-led Group Medical Visits     Usual Care  
STARTED     117     133  
COMPLETED     97     117  
NOT COMPLETED     20     16  



  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
Pharmacist-led Group Medical Visits

Pharmacist-led group medical visits which consists of medication titration and behavioral modification

Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes

Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals

Group support: Peer support are provided in the group setting

Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision

Usual Care Patients continued on usual care without pharmacist-led group medical visits
Total Total of all reporting groups

Baseline Measures
    Pharmacist-led Group Medical Visits     Usual Care     Total  
Number of Participants  
[units: participants]
  117     133     250  
Age  
[units: years]
Mean ± Standard Deviation
  65.8  ± 8.7     65.0  ± 9.8     65.4  ± 9.3  
Gender  
[units: participants]
     
Female     112     128     240  
Male     5     5     10  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     88     104     192  
African American     12     15     27  
Asian Pacific Islander     15     8     23  
Hispanic     0     4     4  
Unknown     2     2     4  
Hemoglobin A1c  
[units: percentĀ HemoglobinĀ A1c]
Mean ± Standard Deviation
  8.2  ± 1.5     8.2  ± 1.3     8.2  ± 1.4  
Systolic Blood Pressure  
[units: mmHg]
Mean ± Standard Deviation
  136.5  ± 19.0     136.2  ± 17.4     136.3  ± 18.1  
LDL cholesterol  
[units: mg/dL]
Mean ± Standard Deviation
  87.6  ± 29.8     93.7  ± 33.7     91.0  ± 32.1  



  Outcome Measures
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1.  Primary:   Hemoglobin A1c   [ Time Frame: 6 months ]

2.  Primary:   Hemoglobin A1c   [ Time Frame: 13 months ]

3.  Secondary:   Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment   [ Time Frame: 13 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   Safety Issue:   No

4.  Secondary:   Health-care Costs to the VHA   [ Time Frame: 13 months (during study) and 13 months (after the study) = 26 months ]
Results not yet reported.   Anticipated Reporting Date:   04/2015   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:  
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: Wen-Chih Wu, MD
Organization: Providence VA Medical Center
phone: 4012737100 ext 6237
e-mail: wen-chih.wu@va.gov


Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00554671     History of Changes
Other Study ID Numbers: IAB 06-269
Study First Received: November 5, 2007
Results First Received: December 4, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government