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

Tracking Information
First Submitted Date ICMJE	July 24, 2006
First Posted Date ICMJE	July 28, 2006
Last Update Posted Date	April 16, 2014
Study Start Date ICMJE	July 2003
Actual Primary Completion Date	May 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 19, 2007)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: July 26, 2006)	The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.
Change History	Complete list of historical versions of study NCT00358033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
Official Title ICMJE	Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Diabetes; Dyslipidemia; Hypertension; Coronary Atherosclerosis
Intervention ICMJE	Behavioral: Counseling; Behavioral: Interactive Education; Behavioral: Group Support; Procedure: Pharmacologic case management Provided by clinical pharmacists
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 26, 2006)	200
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	May 2008
Actual Primary Completion Date	May 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC); Eligible for CRRC discharge: For DM patients: HbA1c < 7.0 %, BP < 130/85 mm Hg , and LDL < 100 mg/dl; 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00358033
Other Study ID Numbers ICMJE	12712
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Wen-Chih Wu, Providence VA Medical Center
Study Sponsor ICMJE	Providence VA Medical Center
Collaborators ICMJE	Merck Sharp & Dohme Corp.
Investigators ICMJE	Principal Investigator: Wen-Chih Wu, MD Providence VAMC
PRS Account	Providence VA Medical Center
Verification Date	April 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP