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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014