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

Tracking Information

First Received Date ^ICMJE

July 24, 2006

Last Updated Date

April 14, 2014

Start Date ^ICMJE

July 2003

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: 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

Enrollment ^ICMJE

200

Completion Date

May 2008

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:
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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

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