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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00357955
First Posted: July 28, 2006
Last Update Posted: May 13, 2014
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.
Collaborator:
Rhode Island Foundation
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center
  Purpose
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
Diabetes Hypertension Dyslipidemia 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: None (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 Wen-Chih Wu, 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Rhode Island
Providence VAMC
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Providence VA Medical Center
Rhode Island Foundation
Investigators
Principal Investigator: Wen-Chih Wu, MD Providence VAMC
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wen-Chih Wu, Staff Cardiologist, 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
Last Verified: April 2014

Additional relevant MeSH terms:
Dyslipidemias
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Lipid Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases