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

This study is ongoing, but not recruiting participants.

First Received: July 24, 2006 Last Updated: September 19, 2007 History of Changes

Sponsors and Collaborators:	Providence VA Medical Center Rhode Island Foundation
Information provided by:	Providence VA Medical Center
ClinicalTrials.gov Identifier:	NCT00357955

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

MedlinePlus related topics: Diabetes High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

Percent of compliance to the ADA guidelines 3-months after completion of the study programs in any one of the following measures: smoking, LDL-C, BP, and Hb-A1c. [ Time Frame: 4 months ]

Estimated Enrollment:	120
Study Start Date:	August 2004
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
MEDIC: Experimental 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
usual care: No Intervention usual care

Arms

Assigned Interventions

MEDIC: Experimental

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

usual care: No Intervention

usual care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	12733
Study First Received:	July 24, 2006
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00357955 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Arteriosclerosis

Ischemia
Coronary Disease
Metabolic Disorder
Dyslipidemias
Coronary Artery Disease
Hypertension
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Coronary Disease
Arterial Occlusive Diseases
Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Arteriosclerosis
Dyslipidemias
Coronary Artery Disease
Lipid Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009