Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Conditions
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Diabetes, Hypertension, Dyslipidemia

Intervention / Treatment
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* Other: MEDIC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEDIC Intervention<br>Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction | Other: MEDIC<br>* Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.<br>|
| No Intervention: Usual Care<br>Patient continued on usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group Intervention, Pharmacotherapy, Behavioral Modification, Diabetes