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Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT00357955
Recruitment Status : Completed
First Posted : July 28, 2006
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Hypertension
Dyslipidemia
Coronary Arteriosclerosis
Interventions: Behavioral: Behavioral counseling and peer support
Behavioral: Interactive Education
Behavioral: Role modeling
Procedure: Pharmacologic case management

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible patients were identified by a combination of the review of the VA Medical Center’s electronic medical record system and referral by primary care providers. Recruitment started July 2004 and enrollment was completed by May 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once eligibility confirmed and consent signed, participants were randomized. There were no wash-out or run-in period.

Reporting Groups
  Description
MEDIC

Multidisciplinary education and diabetes intervention for cardiac risk reduction

Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms

Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

Role modeling : learning from peers with similar disease and problems

Interactive Education : interactive lectures with hands-on learning

Usual Care usual care

Participant Flow:   Overall Study
    MEDIC   Usual Care
STARTED   64   54 
COMPLETED   58   51 
NOT COMPLETED   6   3 



  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.
Age, mean in years; Gender, % male; Baseline level of glycemic control

Reporting Groups
  Description
MEDIC

Multidisciplinary education and diabetes intervention for cardiac risk reduction

Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms

Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

Role modeling : learning from peers with similar disease and problems

Interactive Education : interactive lectures with hands-on learning

Usual Care usual care
Total Total of all reporting groups

Baseline Measures
   MEDIC   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   51   109 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   39   20   59 
>=65 years   19   31   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (10.3)   66.8  (10.2)   64.4  (10.5) 
Gender 
[Units: Participants]
     
Female   5   0   5 
Male   53   51   104 
Region of Enrollment 
[Units: Participants]
     
United States   58   51   109 


  Outcome Measures

1.  Primary:   Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg   [ Time Frame: 4 months ]


  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
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  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: Wen-Chih Wu, MD; Principal Investigator
Organization: Providence VA Medical Center
phone: 4012737100 ext 6237
e-mail: wen-chih.wu@va.gov


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

Responsible Party: Wen-Chih Wu, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT00357955     History of Changes
Other Study ID Numbers: 12733
First Submitted: July 24, 2006
First Posted: July 28, 2006
Results First Submitted: January 14, 2014
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014