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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
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 
Overall Participants Analyzed 
[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: Percent Hemoglobin 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: VA Office of Research and Development
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