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OpenTrials
Completed

NCT Number: NCT00357955

Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients

The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.

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Key information

Conditions

Diabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Arteriosclerosis Coronary Artery Disease 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

Not applicable

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

  • All diabetic veterans with a Hb-A1c between 7.0- 9.0 % within the last 6 months will be eligible for the study

Exclusion criteria

  • Patients without an Hb-A1c checked within the last 6 months.
  • Patients who are unable to attend the group sessions, either because of lack of transportation, psychiatric instability (suicidal, psychotic), or organic brain injury that preclude them from diabetes self-care.

Treatment and study plan

Behavioral counseling and peer support

Behavioral

Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention

Interactive Education

Behavioral

interactive lectures with hands-on learning

Role modeling

Behavioral

learning from peers with similar disease and problems

Pharmacologic case management

Procedure

provided by clinical pharmacists following pre-established algorithms

Primary outcomes

  1. Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg

    Time frame: 4 months

    The major outcome was the percentage of participants who attain the target goals for A1C, blood pressure,and ldl cholesterol lipids set by the American Diabetes Association guidelines, defined as A1C <7%, SBP <130 mm Hg, diastolic blood pressure (DBP) <80 mm Hg, and LDL cholesterol <100 mg/dL (2.6 mmol/L).

Sponsors and collaborators

Lead sponsor

Providence VA Medical Center

Fed

Collaborators

  • Rhode Island Foundation

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jul 28, 2006
Registry last updated
Nov 7, 2024

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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