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

Hypertension Clinical Trial

Official title:

Effectiveness of Different Strategies in Maintaining Target Goals of Cardiovascular Risk Factors in Patients Discharged From Cardiovascular Risk Reduction Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358033
• Other study ID #: 12712
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2006
• Last updated: April 14, 2014
• Start date: July 2003
• Est. completion date: May 2008

Study information

• Verified date: April 2014
• Source: Providence VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Diabetes
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Myocardial Ischemia

Intervention

Behavioral:
• Counseling

• Interactive Education

• Group Support

Procedure:
• Pharmacologic case management
Provided by clinical pharmacists

Locations

Country	Name	City	State
United States	Providence VAMC	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Providence VA Medical Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.		12 months	No