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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center
ClinicalTrials.gov Identifier:
NCT00358033
First received: July 24, 2006
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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
Diabetes
Dyslipidemia
Hypertension
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center
ClinicalTrials.gov 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:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Dyslipidemias
Hypertension
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014