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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357955
• Other study ID #: 12733
• Status: Completed
• Phase: N/A
• First received: July 24, 2006
• Last updated: April 14, 2014
• Start date: August 2004
• Est. completion date: May 2008

Study information

• Verified date: April 2014
• Source: Providence VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Diabetes
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Myocardial Ischemia

Intervention

Behavioral:
• Behavioral counseling and peer support
Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention
• Interactive Education
interactive lectures with hands-on learning
• Role modeling
learning from peers with similar disease and problems

Procedure:
• Pharmacologic case management
provided by clinical pharmacists following pre-established algorithms

Locations

Country	Name	City	State
United States	Providence VAMC	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Providence VA Medical Center	Rhode Island Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1177/0145721709352383. Epub 2009 Dec 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg	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).	4 months	No