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Completed

NCT Number: NCT00409240

Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Our study intends to test the efficacy of pharmacist-led group interventions on a weekly basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Providence VAMC

Providence, Rhode Island, 02908, United States

About this study

Our project intends to study the 6-month efficacy of a pharmacist-led group intervention program that simultaneously target diabetes, hypertension and dyslipidemia. We hypothesize that pharmacist-led group interventions on a weekly basis for 4-weeks then on a monthly basis for 5 additional months may achieve concomitant reductions in hemoglobin A1c, lipids and blood pressure. We are proposing a pilot randomized controlled study to test the efficacy and feasibility of this approach.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes mellitus,
  • >18 years old,
  • with a documented HbA1c more than 7.0%,
  • an LDL cholesterol >100 mg/dl AND a blood pressure >130/80 mm Hg documented at least once in the medical records within the last 6 months, and
  • willing to comply with the study interventions will be eligible for the study.

Exclusion criteria

  • pregnancy,
  • unable to attend the group sessions,
  • disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing diabetes self-care,
  • enrolled in the Providence VAMC's Telehealth program

Treatment and study plan

MEDIC

Other

Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.

Primary outcomes

  1. Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study

    Time frame: 6 months

    Hemoglobin A1C target was < 7% LDL cholesterol goal of < 100mg/dl or <70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of <130mm Hg

Sponsors and collaborators

Lead sponsor

Providence VA Medical Center

Fed

Collaborators

  • Sandra A. Daugherty Foundation

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 8, 2006
Registry last updated
Apr 11, 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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