Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic

NCT ID: NCT00358033

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.

Detailed Description

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Conditions

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Diabetes Dyslipidemia Hypertension Coronary Atherosclerosis

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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group intervention

pharmacist-led group intervention in behavioral and pharmacologic therapy

Group Type EXPERIMENTAL

Counseling

Intervention Type BEHAVIORAL

Interactive Education

Intervention Type BEHAVIORAL

Group Support

Intervention Type BEHAVIORAL

Pharmacologic case management

Intervention Type PROCEDURE

Provided by clinical pharmacists

individual

pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction

Group Type ACTIVE_COMPARATOR

Counseling

Intervention Type BEHAVIORAL

Pharmacologic case management

Intervention Type PROCEDURE

Provided by clinical pharmacists

usual care

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Counseling

Intervention Type BEHAVIORAL

Interactive Education

Intervention Type BEHAVIORAL

Group Support

Intervention Type BEHAVIORAL

Pharmacologic case management

Provided by clinical pharmacists

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)
* Eligible for CRRC discharge:

1. For DM patients:

* HbA1c \< 7.0 %,
* BP \< 130/85 mm Hg , and
* LDL \< 100 mg/dl;
2. For Non-DM patients:

* BP \< 140/90 mm Hg, and
* LDL \< 100 mg/dl;
* Able and willing to sign informed consent.

Exclusion Criteria

* Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder);
* Metastatic disease or terminal illness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

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

Other Identifiers

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12712

Identifier Type: -

Identifier Source: org_study_id

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