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

Providence VA Medical Center

Status and phase: Completed; Phase 3

Conditions: Hypertension; Diabetes; Coronary Atherosclerosis; Dyslipidemia

Treatments: Behavioral: Interactive Education; Procedure: Pharmacologic case management; Behavioral: Group Support; Behavioral: Counseling

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT00358033

12712

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

group intervention

Experimental group

Description:

pharmacist-led group intervention in behavioral and pharmacologic therapy

Treatment:

Behavioral: Interactive Education

Behavioral: Counseling

Procedure: Pharmacologic case management

Behavioral: Group Support

individual

Active Comparator group

Description:

pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction

Treatment:

Behavioral: Counseling

Procedure: Pharmacologic case management

usual care

No Intervention group

Description:

usual care