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

Not Applicable

Completed

• Conditions: Diabetes; Hypertension; Dyslipidemia; Coronary Arteriosclerosis
• Interventions: Behavioral: Behavioral counseling and peer support; Behavioral: Interactive Education; Behavioral: Role modeling; Procedure: Pharmacologic case management

• Registration Number: NCT00357955
• Lead Sponsor: Providence VA Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-28
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2014-01-14
• Results First Submitted QC: 2014-04-14
• Results First Posted: 2014-05-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDIC	Behavioral counseling and peer support	Multidisciplinary education and diabetes intervention for cardiac risk reduction
MEDIC	Interactive Education	Multidisciplinary education and diabetes intervention for cardiac risk reduction
MEDIC	Role modeling	Multidisciplinary education and diabetes intervention for cardiac risk reduction
MEDIC	Pharmacologic case management	Multidisciplinary education and diabetes intervention for cardiac risk reduction

Primary Outcome Measures

Name	Time	Method
Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg	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).

Trial Locations

Locations (1)

Providence VAMC; 🇺🇸 Providence, Rhode Island, United States