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
  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:


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

  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):
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 April 15, 2014