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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2007 by Providence VA Medical Center.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Rhode Island Foundation

Information provided by:

Providence VA Medical Center

ClinicalTrials.gov Identifier:

NCT00357955

First received: July 24, 2006

Last updated: September 19, 2007

Last verified: September 2007

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Diabetes High Blood Pressure

U.S. FDA Resources

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
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

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

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 by Providence VA Medical Center

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

Taveira TH, Friedmann PD, Cohen LB, Dooley AG, Khatana SA, Pirraglia PA, Wu WC. Pharmacist-led group medical appointment model in type 2 diabetes. Diabetes Educ. 2010 Jan-Feb;36(1):109-17. Epub 2009 Dec 4.

Khatana SA, Taveira TH, Choudhary G, Eaton CB, Wu WC. Change in hemoglobin A(1c) and C-reactive protein levels in patients with diabetes mellitus. J Cardiometab Syndr. 2009 Spring;4(2):76-80.

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

Additional relevant MeSH terms:

Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Hypertension
Dyslipidemias
Arterial Occlusive Diseases

Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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