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

NCT ID: NCT00357955

Last Updated: 2024-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Diabetes Hypertension Dyslipidemia Coronary Arteriosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEDIC

Multidisciplinary education and diabetes intervention for cardiac risk reduction

Group Type EXPERIMENTAL

Behavioral counseling and peer support

Intervention Type BEHAVIORAL

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

Interactive Education

Intervention Type BEHAVIORAL

interactive lectures with hands-on learning

Role modeling

Intervention Type BEHAVIORAL

learning from peers with similar disease and problems

Pharmacologic case management

Intervention Type PROCEDURE

provided by clinical pharmacists following pre-established algorithms

usual care

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioral counseling and peer support

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

Intervention Type BEHAVIORAL

Interactive Education

interactive lectures with hands-on learning

Intervention Type BEHAVIORAL

Role modeling

learning from peers with similar disease and problems

Intervention Type BEHAVIORAL

Pharmacologic case management

provided by clinical pharmacists following pre-established algorithms

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Foundation

OTHER

Sponsor Role collaborator

Providence VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Wen-Chih Wu

Staff Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen-Chih Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Providence VAMC

Locations

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Providence VAMC

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19966072 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19614793 (View on PubMed)

Other Identifiers

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12733

Identifier Type: -

Identifier Source: org_study_id

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