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

Phase 3

Completed

• Conditions: Dyslipidemia; Diabetes; Hypertension; Coronary Atherosclerosis
• Interventions: Behavioral: Counseling; Behavioral: Interactive Education; Behavioral: Group Support; Procedure: Pharmacologic case management

• Registration Number: NCT00358033
• Lead Sponsor: Providence VA Medical Center

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 available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-28
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group intervention	Counseling	pharmacist-led group intervention in behavioral and pharmacologic therapy
group intervention	Interactive Education	pharmacist-led group intervention in behavioral and pharmacologic therapy
group intervention	Group Support	pharmacist-led group intervention in behavioral and pharmacologic therapy
group intervention	Pharmacologic case management	pharmacist-led group intervention in behavioral and pharmacologic therapy
individual	Counseling	pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction
individual	Pharmacologic case management	pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction

Primary Outcome Measures

Name	Time	Method
The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.	12 months

Trial Locations

Locations (1)

Providence VAMC; 🇺🇸 Providence, Rhode Island, United States