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

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ClinicalTrials.gov Identifier: NCT00357955
Recruitment Status : Completed
First Posted : July 28, 2006
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

July 24, 2006
July 28, 2006
January 14, 2014
May 13, 2014
May 13, 2014
August 2004
May 2008   (Final data collection date for primary outcome measure)
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).
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.
Complete list of historical versions of study NCT00357955 on ClinicalTrials.gov Archive Site
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Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients
Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Hypertension
  • Dyslipidemia
  • Coronary Arteriosclerosis
  • 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
  • Experimental: MEDIC
    Multidisciplinary education and diabetes intervention for cardiac risk reduction
    Interventions:
    • Behavioral: Behavioral counseling and peer support
    • Behavioral: Interactive Education
    • Behavioral: Role modeling
    • Procedure: Pharmacologic case management
  • No Intervention: usual care
    usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
May 2008
May 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00357955
12733
Yes
Not Provided
Not Provided
Wen-Chih Wu, Providence VA Medical Center
Providence VA Medical Center
Rhode Island Foundation
Principal Investigator: Wen-Chih Wu, MD Providence VAMC
Providence VA Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP