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

This study has been completed.
Rhode Island Foundation
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center Identifier:
First received: July 24, 2006
Last updated: April 14, 2014
Last verified: April 2014
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 Intervention
Coronary Arteriosclerosis
Behavioral: Behavioral counseling and peer support
Behavioral: Interactive Education
Behavioral: Role modeling
Procedure: Pharmacologic case management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients

Further study details as provided by Providence VA Medical Center:

Primary Outcome Measures:
  • 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).

Enrollment: 118
Study Start Date: August 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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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Please refer to this study by its identifier: NCT00357955

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center Identifier: NCT00357955     History of Changes
Other Study ID Numbers: 12733
Study First Received: July 24, 2006
Results First Received: January 14, 2014
Last Updated: April 14, 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Lipid Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases processed this record on April 28, 2017