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

This study is ongoing, but not recruiting participants.

First Received: July 24, 2006 Last Updated: September 19, 2007 History of Changes

Sponsors and Collaborators:	Providence VA Medical Center Merck
Information provided by:	Providence VA Medical Center
ClinicalTrials.gov Identifier:	NCT00358033

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 III

MedlinePlus related topics: High Blood Pressure Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic

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 ]

Estimated Enrollment:	200
Study Start Date:	July 2003
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
group intervention: Experimental 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
individual: Active Comparator pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction	Behavioral: Counseling Procedure: Pharmacologic case management Provided by clinical pharmacists
usual care: No Intervention 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

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

Investigators

Principal Investigator:

Wen-Chih Wu, MD

Providence VAMC

More Information

No publications provided

Study ID Numbers:	12712
Study First Received:	July 24, 2006
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00358033 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Benzocaine
Diabetes Mellitus
Vascular Diseases

Arteriosclerosis
Ischemia
Coronary Disease
Metabolic Disorder
Dyslipidemias
Coronary Artery Disease
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis

Coronary Disease
Cardiovascular Diseases
Coronary Artery Disease
Dyslipidemias
Hypertension
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009