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

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.
 
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:
Rhode Island Foundation
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center

Study Description
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Brief Summary:
The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.

Condition or disease Intervention/treatment Phase
Diabetes Hypertension Dyslipidemia Coronary Arteriosclerosis Behavioral: Behavioral counseling and peer support Behavioral: Interactive Education Behavioral: Role modeling Procedure: Pharmacologic case management Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients
Study Start Date : August 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MEDIC
Multidisciplinary education and diabetes intervention for cardiac risk reduction
 Behavioral: Behavioral counseling and peer support
Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

Behavioral: Interactive Education
interactive lectures with hands-on learning

Behavioral: Role modeling
learning from peers with similar disease and problems

Procedure: Pharmacologic case management
provided by clinical pharmacists following pre-established algorithms
No Intervention: usual care
usual care


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All diabetic veterans with a Hb-A1c between 7.0- 9.0 % within the last 6 months will be eligible for the study

Exclusion Criteria:

  • Patients without an Hb-A1c checked within the last 6 months.
  • Patients who are unable to attend the group sessions, either because of lack of transportation, psychiatric instability (suicidal, psychotic), or organic brain injury that preclude them from diabetes self-care.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357955


Locations
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United States, Rhode Island
Providence VAMC
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Providence VA Medical Center
Rhode Island Foundation
Investigators
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Principal Investigator: Wen-Chih Wu, MD Providence VAMC
More Information
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Publications of Results:

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

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Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT00357955    
Other Study ID Numbers: 12733
First Posted: July 28, 2006    Key Record Dates
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
 Lipid Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases