Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Hypertension Clinical Trial

Official title:

Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409240
• Other study ID #: 1127912
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2006
• Last updated: March 6, 2014
• Start date: October 2006
• Est. completion date: June 2008

Study information

• Verified date: March 2014
• Source: Providence VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Other:
• MEDIC
Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.

Locations

Country	Name	City	State
United States	Providence VAMC	PRovidence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Providence VA Medical Center	Sandra A. Daugherty Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1177/01457217114239 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No