Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
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ClinicalTrials.gov Identifier: NCT00358033 |
Recruitment Status
:
Completed
First Posted
: July 28, 2006
Last Update Posted
: April 16, 2014
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Sponsor:
Providence VA Medical Center
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center
Tracking Information | ||||
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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 |
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 |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |