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

April 14, 2014 updated by: Wen-Chih Wu, Providence VA Medical Center

Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Providence VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care
Experimental: group intervention
pharmacist-led group intervention in behavioral and pharmacologic therapy
Behavioral: Counseling
Behavioral: Interactive Education
Behavioral: Group Support
Procedure: Pharmacologic case management
Provided by clinical pharmacists
Active Comparator: individual
pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction
Behavioral: Counseling
Procedure: Pharmacologic case management
Provided by clinical pharmacists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence VA Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Wen-Chih Wu, MD, Providence VAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 28, 2006

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12712

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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