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

NCT00358033 | Completed Phase 3 DMC

• 1 other identifier: 12712
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Dyslipidemia; Hypertension; Coronary Atherosclerosis

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (3)

group intervention

EXPERIMENTAL

pharmacist-led group intervention in behavioral and pharmacologic therapy

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

individual

ACTIVE COMPARATOR

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

Behavioral: Counseling; Procedure: Pharmacologic case management

usual care

NO INTERVENTION

usual care

Interventions

Counseling BEHAVIORAL

group intervention; individual

Interactive Education BEHAVIORAL

group intervention

Group Support BEHAVIORAL

group intervention

Pharmacologic case management PROCEDURE

Provided by clinical pharmacists

group intervention; individual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)
• Eligible for CRRC discharge:
• For DM patients:
• HbA1c \< 7.0 %,
• BP \< 130/85 mm Hg , and
• LDL \< 100 mg/dl;
• For Non-DM patients:
• BP \< 140/90 mm Hg, and
• LDL \< 100 mg/dl;
• Able and willing to sign informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Providence VA Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Providence VAMC

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Dyslipidemias; Hypertension; Coronary Artery Disease

Interventions

Counseling; Self-Help Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Organizations; Health Care Economics and Organizations

Study Officials

• Wen-Chih Wu, MD

  Providence VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 28, 2006
• Study Start: July 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

US (1)