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

This study has been completed.
Sponsor:
Collaborator:
Rhode Island Foundation
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center
ClinicalTrials.gov Identifier:
NCT00357955
First received: July 24, 2006
Last updated: April 14, 2014
Last verified: April 2014
  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:
  • 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 ] [ Designated as safety issue: No ]
    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

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
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, see Learn About Clinical Studies.

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

Publications:
Additional 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
Study First Received: July 24, 2006
Results First Received: January 14, 2014
Last Updated: April 14, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 20, 2014