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OpenTrials
Completed

NCT Number: NCT00358033

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

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.

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Key information

Conditions

Diabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Providence VAMC

Providence, Rhode Island, 02908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Counseling

Behavioral

Interactive Education

Behavioral

Group support

Behavioral

Pharmacologic case management

Procedure

Provided by clinical pharmacists

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Providence VA Medical Center

Fed

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jul 28, 2006
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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