Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Dyslipidemia; Hypertension
• Interventions: Other: MEDIC

• Registration Number: NCT00409240
• Lead Sponsor: Providence VA Medical Center

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-12-07
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2014-01-14
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-06
• Last Update Submitted: 2014-03-06
• Results First Posted: 2014-04-11
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEDIC Intervention	MEDIC	Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction

Primary Outcome Measures

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

Trial Locations

Locations (1)

Providence VAMC; 🇺🇸 PRovidence, Rhode Island, United States