We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00358033
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : April 16, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Dyslipidemia Hypertension Coronary Atherosclerosis Behavioral: Counseling Behavioral: Interactive Education Behavioral: Group Support Procedure: Pharmacologic case management Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2003
Primary Completion Date : May 2008
Study Completion Date : May 2008

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358033


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

Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT00358033     History of Changes
Other Study ID Numbers: 12712
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Atherosclerosis
Dyslipidemias
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Coronary Disease
Heart Diseases