Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Sandra A. Daugherty Foundation
Information provided by (Responsible Party):
Wen-Chih Wu, Providence VA Medical Center
ClinicalTrials.gov Identifier:
NCT00409240
First received: December 7, 2006
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Hypertension
Dyslipidemia
Other: MEDIC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Providence VA Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 103
Study Start Date: October 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDIC Intervention
Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
Other: MEDIC
Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
No Intervention: Usual Care
Patient continued on usual care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409240

Locations
United States, Rhode Island
Providence VAMC
PRovidence, Rhode Island, United States, 02908
Sponsors and Collaborators
Providence VA Medical Center
Sandra A. Daugherty Foundation
Investigators
Principal Investigator: Wen-Chih Wu, MD Providence VAMC, Brown Medical School
  More Information

Publications:
Responsible Party: Wen-Chih Wu, Staff Cardiologist, Providence VA Medical Center
ClinicalTrials.gov Identifier: NCT00409240     History of Changes
Other Study ID Numbers: 1127912
Study First Received: December 7, 2006
Results First Received: January 14, 2014
Last Updated: March 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Providence VA Medical Center:
Group Intervention
Pharmacotherapy
Behavioral Modification
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on April 16, 2014