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

Primary Purpose

Diabetes, Hypertension, Dyslipidemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral counseling and peer support

Interactive Education

Role modeling

Pharmacologic case management

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Providence VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MEDIC

usual care

Arm Description

Multidisciplinary education and diabetes intervention for cardiac risk reduction

usual care

Outcomes

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

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT00357955

First Posted

July 24, 2006

Last Updated

April 14, 2014

Sponsor

Providence VA Medical Center

Collaborators

Rhode Island Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00357955

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Providence VA Medical Center

Collaborators

Rhode Island Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Hypertension, Dyslipidemia, Coronary Arteriosclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MEDIC

Arm Type

Experimental

Arm Description

Multidisciplinary education and diabetes intervention for cardiac risk reduction

Arm Title

usual care

Arm Type

No Intervention

Arm Description

usual care

Intervention Type

Behavioral

Intervention Name(s)

Behavioral counseling and peer support

Intervention Description

Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

Intervention Type

Behavioral

Intervention Name(s)

Interactive Education

Intervention Description

interactive lectures with hands-on learning

Intervention Type

Behavioral

Intervention Name(s)

Role modeling

Intervention Description

learning from peers with similar disease and problems

Intervention Type

Procedure

Intervention Name(s)

Pharmacologic case management

Intervention Description

provided by clinical pharmacists following pre-established algorithms

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wen-Chih Wu, MD

Organizational Affiliation

Providence VAMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence VAMC

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02908

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19966072

Citation

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.

Results Reference

result

PubMed Identifier

19614793

Citation

Khatana SA, Taveira TH, Choudhary G, Eaton CB, Wu WC. Change in hemoglobin A(1c) and C-reactive protein levels in patients with diabetes mellitus. J Cardiometab Syndr. 2009 Spring;4(2):76-80. doi: 10.1111/j.1559-4572.2008.00042.x.

Results Reference

derived

Learn more about this trial

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

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