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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
History of Changes

July 24, 2006
April 14, 2014
July 2003
May 2008   (final data collection date for primary outcome measure)
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 ]
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
Complete list of historical versions of study NCT00358033 on ClinicalTrials.gov Archive Site
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Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Dyslipidemia
  • Hypertension
  • Coronary Atherosclerosis
  • Behavioral: Counseling
  • Behavioral: Interactive Education
  • Behavioral: Group Support
  • Procedure: Pharmacologic case management
    Provided by clinical pharmacists
  • Experimental: group intervention
    pharmacist-led group intervention in behavioral and pharmacologic therapy
    Interventions:
    • Behavioral: Counseling
    • Behavioral: Interactive Education
    • Behavioral: Group Support
    • Procedure: Pharmacologic case management
  • Active Comparator: individual
    pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction
    Interventions:
    • Behavioral: Counseling
    • Procedure: Pharmacologic case management
  • No Intervention: usual care
    usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00358033
12712
Yes
Not Provided
Not Provided
Wen-Chih Wu, Providence VA Medical Center
Providence VA Medical Center
Merck Sharp & Dohme Corp.
Principal Investigator: Wen-Chih Wu, MD Providence VAMC
Providence VA Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP