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Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Providence VA Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Providence VA Medical Center
Information provided by:
Providence VA Medical Center
ClinicalTrials.gov Identifier:
NCT00409240
First received: December 7, 2006
Last updated: September 19, 2007
Last verified: September 2007
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Providence VA Medical Center:

Primary Outcome Measures:
  • Change in hemoglobin A1c, LDL cholesterol and blood pressure from the enrollment until the end of the study [ Time Frame: 6 months ]

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: June 2008
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

Contacts
Contact: Wen-Chih Wu, MD 401-273-7100 ext 2688 wen-chih.wu@va.gov
Contact: Tracey Taveira, Pharm D 401-273-7100 ext 2244 ttaveira76@hotmail.com

Locations
United States, Rhode Island
Providence VAMC Recruiting
PRovidence, Rhode Island, United States, 02908
Contact: Troo Tucker     401-273-7100 ext 3176     troo.tucker@va.gov    
Sub-Investigator: Tracey TAveira, Pharm D            
Sub-Investigator: Peter Friedmann, MD, MPH            
Sub-Investigator: Charles B Eaton, MD, MS            
Sponsors and Collaborators
Sandra A. Daugherty Foundation
Providence VA Medical Center
Investigators
Principal Investigator: Wen-Chih Wu, MD Providence VAMC, Brown Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00409240     History of Changes
Other Study ID Numbers: 1127912
Study First Received: December 7, 2006
Last Updated: September 19, 2007
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 May 16, 2013