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

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center Identifier:
First received: July 24, 2006
Last updated: April 14, 2014
Last verified: April 2014

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.

Condition Intervention Phase
Coronary Atherosclerosis
Behavioral: Counseling
Behavioral: Interactive Education
Behavioral: Group Support
Procedure: Pharmacologic case management
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic

Resource links provided by NLM:

Further study details as provided by Providence VA Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: July 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: usual care
usual care


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00358033

United States, Rhode Island
Providence VAMC
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Providence VA Medical Center
Merck Sharp & Dohme Corp.
Principal Investigator: Wen-Chih Wu, MD Providence VAMC
  More Information

No publications provided

Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center Identifier: NCT00358033     History of Changes
Other Study ID Numbers: 12712
Study First Received: July 24, 2006
Last Updated: April 14, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases processed this record on April 16, 2014