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Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Primary Purpose

Diabetes, Hypertension, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MEDIC
Sponsored by
Providence VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Group Intervention, Pharmacotherapy, Behavioral Modification, Diabetes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Providence VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MEDIC Intervention

Usual Care

Arm Description

Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction

Patient continued on usual care

Outcomes

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
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

Secondary Outcome Measures

Full Information

First Posted
December 7, 2006
Last Updated
March 6, 2014
Sponsor
Providence VA Medical Center
Collaborators
Sandra A. Daugherty Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00409240
Brief Title
Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
Official Title
Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Providence VA Medical Center
Collaborators
Sandra A. Daugherty Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Dyslipidemia
Keywords
Group Intervention, Pharmacotherapy, Behavioral Modification, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEDIC Intervention
Arm Type
Experimental
Arm Description
Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patient continued on usual care
Intervention Type
Other
Intervention Name(s)
MEDIC
Intervention Description
Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
Primary Outcome Measure Information:
Title
Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chih Wu, MD
Organizational Affiliation
Providence VAMC, Brown Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VAMC
City
PRovidence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22021025
Citation
Cohen LB, Taveira TH, Khatana SA, Dooley AG, Pirraglia PA, Wu WC. Pharmacist-led shared medical appointments for multiple cardiovascular risk reduction in patients with type 2 diabetes. Diabetes Educ. 2011 Nov-Dec;37(6):801-12. doi: 10.1177/0145721711423980. Epub 2011 Oct 21.
Results Reference
result

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Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

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